Nutritional health product for preventing and treating cognitive impairment

Abstract

The present invention relates to a solid nutraceutical composition for the prevention and treatment of cognitive disorders, consisting of an emulsion and a mixture of seed and oil, all of which are naturally derived. The emulsion contains plukenetia volubilis oil; an extract of plant origin, such as turmeric, pepper or cocoa; an emulsifier selected from lecithin, saponaria or maguey extract, or egg white; the sweetening agent is selected from fructo-oligosaccharide, stevia rebaudiana or maguey extract, Italian bee honey and cane sugar; and air is contained. Seeds and oil include pumpkin seeds and plukenetia volubilis oil. Other ingredients selected from cocoa powder, coconut oil, fruit or seed mass, natural juice and protein are also added. Thus, the nutraceutical comprises 3 to 5 sources of fatty acids, phytosterols and triacylglycerol, 2 to 8 sources of antioxidants, up to 3 sources of hypoglycemic agents, and up to 4 sources of anti-cholesterol and anti-inflammatory compounds. In addition, the nutritional health-care product also contains proteins, vitamins, macroelements, microelements and substances for promoting chewing and swallowing of subjects and patients suffering from cognitive impairment. The nutritional health-care product is suitable for preventing and treating Alzheimer's disease; mental, behavioral and developmental disorders, including depression; neurological, digestive, immune, endocrine and circulatory disorders; cardiovascular, cerebrovascular, infectious, parasitic, neoplastic and blood diseases; fatigue, fatigue and malnutrition.

Description

Detailed Description

[0001] The present invention relates to the field of natural products which are intended to produce certain beneficial physiological effects on the human body, said beneficial effects being prophylactic to avoid the occurrence of diseases or disorders or being used as adjuvants in or for the treatment of diseases or disorders. More specifically, although not limited thereto, the present invention relates to cognitive deficits and neurological disorders, in particular Alzheimer's disease.

[0002] Cognitive impairment is a characteristic phenomenon of the natural process of aging. Cognitive impairment is also associated with neurological diseases and disorders and is considered to be caused by factors such as vascular accidents, excessive alcohol consumption and drug abuse. Cognitive impairment is present in Parkinson's disease, Alzheimer's disease (C. Patterson, MD, FRCPC. Cognitive Impairment in the Elderly: Case Finding in Family Practice. Can. Fam. Physician. March 1989; 35: 621-624) and a number of other diseases.

[0003] The onset of cognitive impairment and Alzheimer's disease is associated with a number of other factors of various natures: advanced age, family history pointing to genetic factors, metabolic disorders, cranial trauma, pathological changes in the brain, and disorders of the cholinergic, noradrenergic and serotonergic neurotransmitter systems (Larson EB, Kukull WA, Katzman RL. Cognitive impairment: dementia and Alzheimer's disease. Annu Rev Public Health. 1992; 13: 431-49; Larson EB, Kukull WA, Katzman RL. Alzheimer’s Disease and Mild Cognitive Impairment. Neurol. Clin. August 2007; 25(3): 577–v).

[0004] Although different hypotheses have been proposed to help understand the complex neurodegenerative process of Alzheimer's disease, the causes that promote its development remain unknown to date (Haass, C.; Kaether, C.; Thinakaran, G.; S. Sisodia (2012). Trafficking and proteolytic processing of APP. Cold Spring Harb Perspect Med., 2 p.; Mucke, L.; Selkoe D.J. (2012). Neurotoxicity of amyloid β-protein: Synaptic and network dysfunction. Cold Spring Harb Perspect Med., 2 p.). Most experts believe that the development of Alzheimer's disease is caused by the combined action of multiple modifiable and non-modifiable risk factors (age, gender, family and genetic history, environment, and in addition lifestyle), rather than a single cause (Castello, M.A.; Soriano, S. (2014). On the origin of Alzheimer's disease. Trials and tribulations of the amyloid hypothesis. Ageing Res Rev, 13 pp. 10-12; Drachman, D.A. (2014). The amyloid hypothesis, time to move on: Amyloid is the downstream result, not cause, of Alzheimer's disease. Alzheimers Dement, 10 pp. 372-380).

[0005] Currently, the two most widely accepted hypotheses for the causes in the scientific community are the overphosphorylation of tau protein and the amyloid cascade reaction. In a neuropathological situation, amyloid precursor protein (APP) is metabolized through the amyloidogenic pathway. During this process, β-secretase generates a soluble N-terminal fragment called APPsβ; in addition, such cleavage produces the C99 fragment. Subsequently, γ-secretase cleaves at the C-terminus of this fragment, generating Aβ40 / 42 fragments. Compared with Aβ40, the Aβ42 peptide is not only more prone to aggregation but also has stronger neurotoxicity, so it is speculated to be the pathogenic Aβ species. Therefore, Aβ42 oligomerizes and accumulates in the limbic system and association cortex in the form of senile plaques, and then exerts a toxic effect on neuronal synapses (Hong-Qi, Y.; Zhi-Kun, S.; Sheng-Di, C. (2012). Current advances in the treatment of Alzheimer’s disease: focused on considerations targeting Aβ and tau. Trans. Neurodeg.; 1:1-21; Selkoe, D. J.; Hardy, J. (2016). The amyloid hypothesis of Alzheimer’s disease at 25 years. EMBO molecular medicine 8:595–608).

[0006] The toxic effects of senile plaques trigger a glial response by activating astrocytes and surrounding microglia. This action causes the release of cytokines or components of the complement system, leading to an inflammatory response. It also induces oxidative stress in neurons, causing changes in calcium ion homeostasis through the overactivation of protein kinases and the inactivation of phosphatases. For this reason, tau protein is overphosphorylated and forms neurofibrillary tangles, which accumulate in synapses and neuronal cell bodies, leading to neuronal death through apoptosis and causing a lack of neurotransmitters. This series of processes leads to the onset of dementia (Selkoe, D. J.; Hardy, J. (2016). The amyloid hypothesis of Alzheimer’s disease at 25 years. EMBO molecular medicine 8:595–608).

[0007] There is a theory that is currently very popular and that relates to disorders at the metabolic level, particularly those related to insulin resistance at the brain level. This disorder is characterized by a decrease in the ability of insulin to perform its normal physiological functions (Serrano M.;Cascales,M.(2015).Resistencia a la insulina,inflamación y obesidad,1:377-399). Studies have found that the receptors for this hormone are mainly present at the hippocampal level and that when these receptors are activated, they allow neurons to use glucose. It seems that a series of enzymes are activated that have a detoxifying effect related to the toxic effects of amyloid plaques, although this phenomenon has only been observed in animal models (Jagua,A.;Avila,A.(2007).Insulina y enfermedad de Alzheimer: diabetes tipo 3?.Rev Med UnivNac Colomb.55(1):p.6-70.). Therefore, a viable treatment option is to add certain nutrients to the diet to obtain alternative energy through metabolic pathways other than glycolysis, to counteract neuronal death due to lack of glucose and to improve the condition of the patient regardless of the stage of the disease. In this context, ketone bodies produced from medium-chain triglycerides (MCTG) constitute an alternative energy source when cells lack glucose (Hu,I.;Ortí,J.E.R.;Sabater,P.S.;Castillo S.S.;Rochina,M.J.(2015).Aceite de coco:tratamientoalternativo no farmacológico frente a la enfermedad de Alzheimer.UniversidadCatólica de Valencia. Nutr Hosp.32(6):2822-2827ISSN 0212-1611).

[0008] Some of the alternative hypotheses proposed so far are as follows: altered mitochondrial activity and neuroinflammation (Felice F.D., Lourenco M, Ferreira S. (2014). How does brain insulin resistance develop in Alzheimer's disease? Alzheimers Dement 10:S26-32). Finally, a dendritic hypothesis of Alzheimer's disease has also been proposed. All of these demonstrate the complexity of this disease and, in addition, confirm the fact that the mechanisms leading to neuronal death through apoptosis have not been fully elucidated (Boada, M.; Ramos-Fernández, E.; Guivernau, B.; F.J.; Costa, M.; Ortiz, A.M. (2016). Tratamiento de la enfermedad de Alzheimer mediante terapia combinada de aféresis terapéutica y hemoféresis con albúmina e inmunoglobulina intravenosa: fundamentos y aproximación terapéutica al estudio AMBAR (Alzheimer Management by Albumin Replacement). Sociedad de Neurología. 31(7):473-481).

[0009] The peroxidation reaction leads to impaired mitochondrial function and may trigger cell death. The damage caused by this reason is considered to be one of the most common damages in the pathogenesis of cognitive impairment (Warren E.B., Morrow E.M. Mitochondrial Function in 22q11 Deletion Syndrome. Neuron. Vol. 102, No. 6, June 19, 2019, 1089 - 1091; Jara C., Torres A.K., Olesen M.A., Tapia - Rojas C. Mitochondrial Dysfunction as a Key Event during Aging: From Synaptic Failure to Memory Loss. Referenced from https: / / www.intechopen.com / predownload / 68488 published on February 28, 2020; Mancuso M., Calsolaro V., Orsucci D., Carlesi C., Choub A., Piazza S., and Siciliano G. Mitochondria, Cognitive Impairment, and Alzheimer's Disease. Int J Alzheimers Dis. 2009; 2009:951548. Published online on July 6, 2009).

[0010] On the other hand, the effects of medium - chain fatty acids have been described in the inflammatory process, particularly in neuroinflammation.

[0011] In subjects with Alzheimer's disease, due to insulin resistance being at the brain level rather than in other parts of the body, brain neurons cannot metabolize glucose. Because of this, the body is unable to synthesize the essential ketone bodies to provide the alternative energy required for neuron survival. Ketone bodies can be derived from medium-chain triglycerides, which are easily ionizable at the pH of human blood, making them more soluble and able to be better emulsified in smaller droplets, which are more easily processed by lipase compared to larger-chain droplets. Additionally, all of these enable better oxidation of medium-chain triglycerides in the liver, resulting in the formation of more ketone bodies. It has been proposed that this process will ultimately improve blood flow and cognitive ability in normal subjects (Hasselbalch S.G., Madsen P.L., Hageman L.P., Olsen K.S., Justesen N., Holm S., Paulson O.B. Changes in cerebral blood flow and carbohydrate metabolism during acute hyperketonemia. American Journal of Physiology-Endocrinology and Metabolism, Vol. 270, No. 5; Veneman T., Mitrakou A., Cryer P, Gerich J.E. Effect of Hyperketonemia and Hyperlacticacidemia on Symptoms, Cognitive Dysfunction, and Counterregulatory Hormone Responses During Hypoglycemia in Normal Humans. Diabetes November 1994; 43(11):1311-1317).

[0012] According to Sloan E., the ingredients of nutraceuticals include fatty acids, vitamins, minerals, antioxidants, and other biologically active substances for the human body, which are contained in foods and can affect the physiology of the brain and the state and vitality of neurons. Sloan pointed out that some of these substances interfere with the synthesis of proteins, carbohydrates, and lipids that form the brain structure, as well as the synthesis of neurotransmitters, and ensure the function of synapses and neurons, thus enabling normal cognitive function to be achieved (Sloan, E. The top 10 trends to watch and work on. Food Technol. 50(7): pp. 55-71, 1996).

[0013] U.S. Patent No. 6,914,071 describes a diet and method for suppressing mental decline in pets. The diet includes antioxidants or a mixture of antioxidants. The invention is shown not to be applicable to humans.

[0014] U.S. Patent No. 6426362 details a composition that improves the effect of stress on energy metabolism by using tocopherols and / or their derivatives and other compounds (such as flavonoids and lactoferrin) or derivatives of these compounds. The compounds contained in these substances are not described in depth, nor is the neuroprotective effect.

[0015] The authors of Patent Application DE 4303214A1 claim the use of a wide range of saponins and sapogenins for viral diseases that have no proven association with neurological diseases or cognitive impairments.

[0016] The authors of Spanish Patent ES2209539T3 disclose the use of plant extracts with antioxidant effects and cosmetic or dermatological drug compositions containing such extracts. Among the plant materials described is Clidemia hirta. The invention does not claim any effect on cognitive impairment or its prevention or as a palliative therapy. The mechanism of action is also not applicable to the indications for such purposes.

[0017] In U.S. Patent No. 5,985,936, the authors claim a method for preventing or delaying the onset of Alzheimer's disease that includes a composition of plant sterols (β-sitosterol, campesterol, and stigmasterol) with antioxidant activity to protect the brain from oxidative stress. However, the invention does not reverse any other causes attributed to the onset of the disease.

[0018] Similarly, Invention Application No. 20170065660 from the United States shows a liquid composition with an alkaline pH formed by combining orange and vanilla extracts, honey, agave syrup, apple cider vinegar, olive oil and coconut oil, multivitamins, Aloe vera juice, and other ingredients, and aims to provide energy and reduce inflammation. The invention does not describe the use of substances with a considerable antioxidant potential or acting on other mechanisms that trigger cognitive impairment and Alzheimer's disease.

[0019] Spanish Patent 2 323 940 describes a method for the treatment and prevention of Alzheimer's disease using medium-chain triglycerides. The product is presented in the form of a food bar, in which medium-chain fatty acids are emulsified together with L-carnitine, glycerol, corn syrup solids, cocoa, and a coating. It involves orally administering a single dose of medium-chain triglycerides to a patient, such that the level of D-β-hydroxybutyric acid in the patient's blood is elevated to 1 - 10 mM, or the excretion of D-β-hydroxybutyric acid in urine is in the range of 5 mg / dl to 160 mg / dl, thereby causing the patient to develop hyperketonemia. This enables the brain to utilize ketone bodies as an energy source in the presence of glucose. This invention has certain limitations. One of them is that the patient or subject needs to have relevant parameters detected in a professional laboratory. Like the previously described technical solutions, it can neither correct or prevent other substance metabolism defects that lead to cognitive impairment, nor does it show antioxidant, cholesterol-lowering effects, nor the ability to lower triglycerides. It also has no effect on the gut microbiota.

[0020] Other patents describe the uses of supplements containing vitamins, carotenoids, ω-3 fatty acids, and other nutrients, which theoretically have antioxidant capabilities and can also supply energy to the brain, but none of them have shown any benefits to the nervous system, the brain, or its functions, let alone having an effect on cognitive impairment and Alzheimer's disease (U.S. Patents Nos. 6,579,544 and 6,140,304).

[0021] Curcumin has been used in several inventions for the prevention and treatment of nervous system diseases. Thus, U.S. Patent No. 5,834,044 describes a method for obtaining a food composed of a turmeric extract containing curcumin, which is mixed with a lipid phase of medium-chain or long-chain saturated fatty acids and also combined with vitamin B. The structure of this product makes it difficult for the elderly to absorb because it has a coating and an uneven structure. In addition, since the product itself does not have natural substances that can prevent the degradation of various compounds, a coating is needed to avoid the degradation of these compounds. Moreover, the product cannot prevent the appearance of unwanted or unacceptable colors, so a coating is required. Additionally, this product is only effective when combined with physical exercise. Finally, no beneficial effects on cognitive impairment or Alzheimer's disease are mentioned.

[0022] On the other hand, the low bioavailability of curcuminoids is well-known. Even when ingesting dozens of grams of these compounds daily in the form of extracts or powdered rhizomes, only micrograms are absorbed. Patent WO2019018445 describes the use of kaysarin as a pharmaceutical ingredient together with curcumin dissolved in coconut oil. It also describes the use of the fatty acids that make up the oil, specifically docosahexaenoic acid, caprylic acid, capric acid, and lauric acid. The drawback of this method is that the concentrations of kaysarin LL-37 and β-amyloid peptide in the subject's tissue must be determined in advance, which not only has an invasive effect on the body but is also not suitable for prevention in subjects with normal levels of these two parameters. In addition, under this form of ingestion, the drawback of low bioavailability of curcumin and other curcuminoids has also been observed.

[0023] Examples of using plant-derived compounds to prevent neurological diseases appear in US Patent Application 20180325842A1. The tablets are composed of a combination of turmeric extract and mannitol in a ratio of 1:1 to 1:3. A system with a particle size of 100 to 250 nm is formed. Soy lecithin is used as the lipid phase to dissolve the extract and improve bioavailability. It is mixed with other ingredients, including piperine, silybin, and stevia extract. The tablets contain very few curcuminoids and are not sufficient to achieve an effective effect. Lecithin is not used as a foaming agent or emulsifier but only as a solubilizer. Tablets are not the most suitable way to provide substances to the elderly, especially for those who have difficulty eating independently, such as those with advanced neurological diseases.

[0024] US Patent No. 4451488 describes a rod-shaped intermediate-moisture food with easy chewability and high stability, which combines at least two purified alcohols (sorbitol and glycerol). Its ingredients include coconut, cocoa, and antioxidants. However, this document does not propose any beneficial effects on cognitive status, neurological health, or the general human health status. The nature of the antioxidant is not described.

[0025] International Application WO 2006 / 053379 A1 discloses a series of plant-derived compositions that contain fatty acids, carotenoids, and other compounds that can prevent Alzheimer's disease or have a therapeutic effect. The source of the fatty acids is palm oil. The presented forms do not include solid forms suitable for the elderly who have difficulties in nutrient absorption. These forms include liquids, tablets, etc., but it is not described how these forms make their ingredients have high bioavailability. Nor is the therapeutic or preventive effect on Alzheimer's disease proven in animal models or humans.

[0026] The patent application WO 2006 / 121985 A1, "Antioxidant food compositions and methods and uses thereof", describes a composition for slowing or preventing cognitive decline, used alone or in combination with physical exercise or cognitive training. Among other forms, the food is in the form of a bar and contains at least one antioxidant in its natural matrix and at least one ingredient in its processed form. In its natural matrix, vitamin E is combined with at least one complex plant antioxidant and optionally with other key nutrients in synthetic or natural form for neuroprotection. Other compounds such as omega-3 fatty acids, phosphatidylserine and indole-3-propionic acid can be added. The composition is combined with physical exercise for preventing cognitive decline and Alzheimer's disease. This invention can be considered the closest prior art solution to the present invention.

[0027] This invention does not provide or describe foods that meet the sensory property requirements (chewability, ease of swallowing, hardness) of the elderly (who are the most common patients with cognitive impairments, especially Alzheimer's disease), such as ease of chewing and ease of swallowing. In addition, this invention does not include ingredients that may affect other mechanisms that trigger the disease, as it is mainly based on the use of antioxidants and omega-3 fatty acids. It does not foresee significant anti-inflammatory effects, while anti-inflammation is both a cause and a result in Alzheimer's disease. In addition, this invention also provides the uses of synthetically obtained substances. This product does not intervene in the triggering mechanisms of Alzheimer's disease and other cognitive impairments and the central nervous system, such as the anti-aggregation activity of beta-amyloid peptides, the anti-degradation of neurofibrillary tangles, the regulation of arterial blood pressure or the protection of cardiovascular function, nor does it have the activity of angiogenesis or activating neuronal synaptic activity. At the same time, it also does not have antibacterial or anti-parasitic activity.

[0028] So far, there has been no drug, dietary supplement, medicinal food or effective food to prevent, stop, eliminate or reverse cognitive impairments or related neurodegenerative diseases or complex metabolic disorders.

[0029] In summary, it can be said that so far, there has been no food, supplement, dietary supplement or drug whose group of substances or compounds in its composition simultaneously has all the activities against cognitive defects, Alzheimer's disease or other diseases and neuronal disorders and the general central nervous system, such as: antioxidant, anti-inflammatory, anti-hypertensive, providing medium-chain fatty acids and omega-3, omega-6, omega-9 fatty acids to promote ketone body formation, antibacterial, antiviral, antitoxin, promoting neuronal synapse formation, hypoglycemic, cholesterol-lowering, antiplatelet aggregation, anti-beta-amyloid peptide formation, anti-neurofibrillary tangle formation and protecting the cardiovascular system, while also providing fatty acids, vitamins, minerals, proteins, carbohydrates and fibers with different compositions.

[0030] From the prior art, it can be summarized that so far, the described prior art solutions have other deficiencies, such as: · Emulsions cannot completely mask the unwanted color or taste of ingredients from plants, so it is necessary to introduce flavorings and colorants, which are artificial in many cases; · Generally, the ingredients in nutraceuticals and supplements cannot achieve maximum bioavailability because complete dissolution at the interface is not achieved, phase separation occurs, and due to dependence on the fat breakdown process, these ingredients cannot be rapidly and completely absorbed in the body; · In a significant number of technical solutions, high foaming capacity is claimed, but very few can achieve 100% foaming capacity, and even fewer cases can achieve 100% emulsion stability. This is mainly because the related inventions prioritize describing the benefits of using medium-chain fatty acids for preventing Alzheimer's disease without considering combining them with other longer-chain fatty acids, which are suitable for forming emulsions, especially for forming foam inside the emulsion; · Many of the products obtained decompose at room temperature or are sensitive to microbial contamination and require coating, which makes them difficult to digest; · As mentioned above, so far, no product disclosed as a nutraceutical or supplement contains ingredients that can intervene in all processes related to the origin of Alzheimer's disease and other neurological diseases (such as anti-inflammatory, hypoglycemic, cholesterol-lowering, antioxidant, providing alternative energy sources to counter insulin resistance at the neuronal level, antibacterial and antifungal, anthelmintic, anti-β-amyloid peptide aggregation, anti-neurofibrillary tangle formation), ingredients that promote neuronal synapse formation, and ingredients with antihypertensive, antiviral, anthelmintic, antitoxin, antiplatelet aggregation, and cardiovascular protective activities; · Generally, the nutraceuticals and related products described contain only one fatty acid, antioxidant, or anti-inflammatory ingredient, or when they contain more than one such ingredient, they have the same synthetic chemical properties and thus the same metabolic or physiological pathways of action; · Nutraceuticals found in the scientific literature, especially products presented in the form of capsules, tablets, and oral liquids, contain only bioactive substances that act on the central nervous system and are particularly relevant to Alzheimer's disease and do not provide other ingredients that help the subjects taking the products stay energetic. In very few cases, these products contain only one category of these substances, such as the addition of some vitamins, amino acids, or proteins, or only scarce macro- and microelements; · There is currently no such nutraceutical that can not only act on Alzheimer's disease and degenerative diseases but also have an effect on other geriatric diseases or age-related conditions, such as inflammatory processes at other levels (e.g., at the prostate level), urinary frequency diseases, which are very common in these age groups in combination with other comorbid conditions; · In the existing literature, no natural nutritional health products containing medium-chain fatty acids as the sole energy source for neurons, combined with other antioxidants and anti-inflammatory substances, have been found; · Commonly, nutritional health products and supplements for the diseases involved in the present invention contain compounds obtained by chemical synthesis or gene recombination, or compounds obtained from animal sources; · Most nutritional health products described in scientific and patent literature and commercial catalogs usually exist in the form of tablets, other types of tablets, liquids, and capsules, which are not suitable for subjects who have difficulty eating independently or are completely unable to eat independently, patients with neurological disorders, and patients with difficulty chewing or swallowing; · The presentation forms of previously developed products are limited by the presentation form and technical or packaging capabilities, such as tablets, hard capsules, or soft capsules. Therefore, in order to provide a high dose of active ingredients to combat Alzheimer's disease, the product needs to be administered multiple times. It should be noted that in a considerable number of technical solutions, no examples of testing on experimental animals are shown to prove the effectiveness of these doses; · In other cases, for the more severe stages of the disease, the aforementioned finished product forms are not sufficient to meet the needs of the subjects even if administered more frequently; · It has been shown that providing supplements in the form of traditional drugs will induce the subjects receiving the supplements to regard them as drugs and strengthen the feeling of being ill. In many cases, this will trigger depressive feelings and does not reflect health; · Many components of nutritional health products are obtained from very scarce sources through complex methods and expensive equipment, and can only be obtained in certain places on the earth, which limits their sustainability; · Finally, in the relevant literature, we have not found any composition that can show effective and significant cognitive improvement in the short term. Generally speaking, the results of reversing cognitive decline have not been shown. Confirmation is only based on the effects shown in a very small number of examples, and only for some of the components; or in a very small number of technical solutions, it is claimed that in experiments on experimental animals, only slight effects are obtained after several months of treatment.

[0031] · For the first time, studies have shown that compared with young animals, the lipid oxidation damage in the brain homogenates of the group of old mice treated with nutritional health products is less.

[0032] · Unexpectedly, compared with the untreated old mice, the group of mice treated with nutritional health products has shown a statistically significant improvement in antioxidant activity. In the existing technical solutions for old animal models, there have been no relevant reports on using products containing the components described in the present invention and observing such phenomena.

[0033] ·Using the technical solution proposed by the present invention, it is first proved that the cognitive state of experimental animals treated with nutritional health products not only exceeds that of elderly animals, but also shows no significant difference compared with young animals.

[0034] ·In other prior art solutions using the said analysis method, there has been no report that the blood glucose levels of untreated young and elderly animals are reduced.

[0035] For the purposes of the present invention, nutritional health products are a group of active chemical or biological substances that can be natural components of food or added to food and are administered in a dose equal to or higher than that present in the food containing them, assuming that the beneficial effects on health are greater than those of ordinary food and can enhance the state of health, assist in care and maintaining health, as well as prevent and treat diseases and improve the physiological functions of the organism.

[0036] The cognitive deficiencies or impairments in the present invention involve but are not limited to the occurrence of one of the following symptoms: impaired short-term, medium-term or long-term memory; impaired learning, attention and concentration.

[0037] The ratios between different components in the present invention are expressed as mass:mass (m / m), and in specific cases as volume:volume (v / v), and all ensure the correct implementation of different variants.

[0038] The following is a detailed description of the present invention.

[0039] Preparation of the emulsion components: To prepare the emulsion, an aqueous liquid phase is first selected, which can consist of water, an aqueous solution of Piper nigrum extract or Theobroma cacao extract or a combination thereof, in a proportion of 3% m / m to 30% m / m relative to the total mass of the nutritional health product.

[0040] The pepper extract was purchased from a commercial supplier or prepared by extracting a commercial powder from peppers grown in Cuba (Fiallo, V.R.F. and Castro, L.P.L. (2000). Apuntes para la flora económica de Cuba III. Plantas condimenticias. Revista del Jardín Botánico Nacional, 21(1), 47–70. http: / / www.jstor.org / stable / 42597069), (Jorge A. Pino, Juan Agüero and Victor Fuentes (2003) Chemical Composition of the Aerial Parts of Piper nigrum L. from Cuba, Journal of Essential Oil Research, 15:3, 209-210, DOI: 10.1080 / 10412905.2003.9712116).

[0041] The cocoa extract was purchased from commercial suppliers or obtained from cocoa powder grown on an industrial scale in Cuba (Damaris de la C. Salgado, Max Monan, J.G.D.P.I.G.R.S.E.G. (2018). Pharmacognostic and Physicochemical Studies of Theobroma cacao bean husk in Cuba. International Invention of Scientific Journal, 2(07). Retrieved from http: / / iisj.in / index.php / iisj / article / view / 54), (Fajardo Rosabal, L., Figueredo Delgado, Y., Rosabal Cordoví, U., Guardia Puebla, Y., Rodríguez Pérez, S., Silva-Pupo, J. and Viera Tamayo, Y. (2020). Contenido de polifenoles totales en callos de Theobroma cacao L. clon ‘UF-650’. Biotecnología Vegetal, 20(1), 63-72. Recuperado de https: / / revista.ibp.co.cu / index.php / BV / article / view / 656).

[0042] If it is desired to prepare an aqueous phase with a solid phase added, the solid phase is selected to consist of a soluble solid or a water-suspendable solid, wherein: - Fructooligosaccharide sweetener, developed by the Center of Genetic Engineering and Biotechnology of Cuba and commercialized by the Research Institute of Sugar Cane and its Derivatives of Cuba, in an amount of 1% m / m to 30% m / m relative to the quality of the nutraceutical (Pérez-Cruz, E.R., Martínez-García, D., Rodriguez-Rico, I., Sobrino-Legón, A. and Hernández, L. (2011). Escalado de la reacción de biosíntesis de fructooligosacáridos, a partir de sacarosa, en bioreactores tipo tanque agitado. Tecnología Química, XXXI(2), 19-25.), (Centro de Ingeniería Genética y Biotecnología. Enzimas Industriales. https: / / www.cigb.edu.cu / research / enzimas-industriales-2 / ).

[0043] - Stevia rebaudiana extract, from plants grown in Cuba (Rodríguez González, Horacio, Acosta de la Luz, Lérida L, Hechevarría Sosa, Isabel, Rivera Amita, María Magdalena, Rodríguez Ferradá, Carlos Alberto, Sánchez Govín, Ester and Milanés Figueredo, Masgloiris. (2007). Comportamiento del cultivo de Stevia rebaudiana (Bertoni) Bertoni en Cuba. Revista Cubana de Plantas Medicinales, 12(4) Recuperado en 21 de marzo de 2023, de http: / / scielo.sld.cu / scielo.php?script=sci_arttext&pid=S1028-47962007000400004&lng=es&tlng=es), (Ulloa Trujillo L. (2021). Proyecto de investigación valida uso de la Stevia como edulcorante. Agencia Cubana de Noticias. 20 Diciembre. http: / / www.acn.cu / medio-ambiente / 88821-proyecto-avileno-de-investigacion-valida-uso-de-la-stevia-como-edulcorante-fotos), in an amount of 1% m / m to 30% m / m.

[0044] - Honey of Apis mellifera (honey from a commercial supplier), in an amount of 15% m / m to 30% m / m relative to the total mass of the nutraceutical.

[0045] - Sucrose (sugar of commercial quality), in an amount of 1% m / m to 30% m / m relative to the total mass of the nutraceutical.

[0046] - Agave fruit wine, preferably Tequila Agave (Agave tequilana) (Paneque Escalona, T.; Polanco Arias, M.; Jiménez Nogueras, C.; Piquera Palomino, Y. (2019). Estudio etnofarmacológico de algunas especies endémicas de agave utilizados en la medicina tradicional. Revista Científica y Tecnológica UPSE, 6(2) pp. 57 - 66. DOI: 10.26423 / rctu.v6i2.471 ISER), (Maidelys et al. Effect of diet supplementation with meal of Agave tequilana stems on hematological indicators and blood biochemistry of fattening rabbits. Cuban Journal of Agricultural Science, [S.l.], v. 53, n. 4, December 2019. ISSN 2079 - 3480. Available at: http: / / www.cjascience.com / index.php / CJAS / article / view / 920 / 913).

[0047] In the present invention, these substances generally act as sweeteners, although they may participate in other biological functions.

[0048] In certain embodiments, the substances are mixed, preferably honey is mixed with an equal amount of sweetening fructooligosaccharides, or only the fructooligosaccharides alone are mixed. If sugar (sucrose) is selected, a syrup of sugar in water is prepared beforehand. For this purpose, at a temperature of 60 °C to 100 °C, preferably 80 °C to 100 °C, without stirring, the mixture is heated at a ratio of sugar: water of 0.2:1 to 2:1 until the sugar is completely dissolved; then it is cooled to 40 °C to 60 °C. This process with the ratio of sugar to the aqueous phase ensures that the mixture does not crystallize or increase in hardness. On the contrary, it maintains the plasticity of the resulting mixture. Citric acid (0.3% to 0.7% by mass) can be added. In embodiments using fructooligosaccharides, the fructooligosaccharides are added to water and not heated.

[0049] To form the emulsion, an aqueous extract, an alcoholic extract or an aqueous-alcoholic extract of turmeric (Curcuma longa) grown in Cuba is added, in an amount of 0.1% m / m to 10% m / m relative to the mass of the nutraceutical (Espinosa Reyes, Silva Pupo, J., Borges García, M., Fajardo Rosabal, L., Pérez Pérez, J., González Paneque, O., and Sariego Frómeta, S. (2009). Establecimiento y multiplicación invitro de Curcuma longa L.. Biotecnología Vegetal, 9(1). Recuperado de https: / / revista.ibp.co.cu / index.php / BV / article / view / 308), (Fernández Izquierdo A. Cúrcuma: una reina, para Cuba y el mundo. (2021). El 16 junio, 2021. http: / / artemisadiario.cu / 2021 / 06 / curcuma-una-reina-para-cuba-y-el-mundo / ), in an amount of 0.1% m / m to 10% m / m relative to the total mass of the nutraceutical.

[0050] In some embodiments, the emulsifier and / or foaming agent is selected from: - Soybean lecithin and egg lecithin from commercial suppliers, such as those sold by Procesadora de Soya de Santiago de Cuba, are present in a proportion of 0.1% m / m to 1% m / m relative to the total mass of the nutraceutical. (Beatón Ruiz B. (2020) Trabajadores. 24 abril. https: / / www.trabajadores.cu / 20200424 / procesadora-de-soya-de-santiago-de-cuba-estable-en-su-quehacer-productivo / ), (Lemus Rodríguez, Martha Zoe, Chong Quesada, Amaury, and Bosch Escobar, Jorge. (2017). Tableta masticable de lecitina de soya: de subproducto a producto farmacéutico. MEDISAN, 21(5), 556 - 563. Recuperado en 21 de marzo de 2023, de http: / / scielo.sld.cu / scielo.php?script=sci_arttext&pid=S1029-30192017000500007&lng=es&tlng=es)).

[0051] - Extracts of Saponaria species, especially extracts of Saponaria officinalis or Saponaria ocymoides, obtained from commercial suppliers or by extraction from the plant roots, are present in a proportion of 0.1% m / m to 10% m / m relative to the total mass of the nutraceutical. (Saponaria officinalis. Ecured. https: / / www.ecured.cu / Saponaria), (Saponaria: propiedades medicinales, mucho más que para hacer jabón. Eco agricultor. https: / / www.ecoagricultor.com / saponaria-jabon / ).

[0052] - Egg white is present in a proportion of 3% to 35% relative to the total mass of the nutraceutical.

[0053] - Extracts of Agave plants, especially extracts of Agave americana, Agave tequilana or Agave fourcroydes, in an amount of 0.1% m / m to 10% m / m relative to the quality of the nutraceutical (de Zayas, A. (1984). Los agaves de Cuba Occidental. Revista Del Jardín Botánico Nacional, 5(3), 3–16. http: / / www.jstor.org / stable / 42596752)(Acevedo-Rodríguez, P. and Strong, M. T. (2012). Catalogue of seed plants of the West Indies. Smithsonian Contributions to Botany 98:1-1192.)(Vinent Serrano E. y Fajardo Gutiérrez O. Estrategia para el mejoramiento genético de Agaves en Cuba. Instituto de Investigaciones Hortícolas “Liliana Dimitrova” (IIHLD). La Habana, Cuba. https: / / www.utm.mx / edi_anteriores / temas037 / N3.pdf)(Valdivia, A., Rubio Fontanills, Y., Hernández L., Jiménez Rabelo, J., Pérez Hernández, Y., and Portilla Tundidor, Y. (2018). Propiedades fitoquímicas y antibacterianas de los extractos de las hojas de Agave fourcroydes Lem. (henequén). Revista Cubana de Plantas Medicinales, 23(2). Recuperado de https: / / revplantasmedicinales.sld.cu / index.php / pla / article / view / 452 / 302).

[0054] The agave extract can be obtained from companies that commercialize it or by extracting the plant material in water at a temperature of 60 °C to 70 °C for 10 minutes to 30 minutes; the material is crushed, washed with water, mixed for 5 - 8 hours to obtain a decoction, which is decanted and filtered. This process is repeated several times while maintaining the level of active ingredients in the extract equal to or greater than 3% (measurable by solids). After completion, the extract is heated to boiling and concentrated to a total solids of approximately 5% to 15% to ensure that the emulsifying and foaming substances contained in the extract form an oil:water:air:suspended or dissolved solid emulsion. To cause no harm to health, the content of these compounds (saponins) in the final product should not exceed 0.03%, so the amount of extract added to the quality of the nutraceutical is always within the specified limits.

[0055] In some embodiments, according to the present invention, when using agave and saponaria extracts, they are mixed with sugar or honey at a slower rate of 100 l / min to 150 l / min at a temperature of 105 °C to 110 °C for 10 minutes to 30 minutes.

[0056] Subsequently, the oil phase of the emulsion is added, or an oil phase with a solid phase soluble in the oil phase, or an oil phase with a solid phase suspended in the oil phase. The oil phase consists of Sacha Inchi oil prepared by the Cuban Research Center for Protein Plants and Natural Bioproducts from plants grown in Cuba (González de la Torre, L, Rodríguez Leyes E.A., Vicente Murillo R.,.González Canavaciolo V.L, Díaz Rivera Y.Yurisley.Caracterización preliminar del aceite de Plukenetia volubilis L. (sacha inchi) cultivada en Cuba.Revista Cubana de Plantas Medicinales.(2022);27(1):e1227.file: / / / C: / Users / claudio / Downloads / 1227 - 6625 - 1 - PB.pdf), and its proportion is 5% to 20% relative to the total mass of the nutraceutical.

[0057] In some cases, substances that are not dissolved but suspended in the oil can be added to the oil phase, as in the case of some concentrated ethanol or hydroalcoholic extracts of turmeric.

[0058] Then, the components are stirred and mixed at a stirring speed of 100 rpm to 13,000 rpm to obtain an emulsion with a larger droplet size of 201 nm to 10,000 nm; to obtain a microemulsion with a droplet size of 101 nm to 200 nm, a speed of 6,000 rpm to 15,000 rpm is used, and for a nanoemulsion with a droplet size of 60 nm to 100 nm, the speed is 12,000 rpm to 45,000 rpm. In other embodiments, other methods for obtaining microemulsion and nanoemulsion droplets can be used, employing a combination of ultrasonic waves and high pressure with stirring.

[0059] When stirring these components, a gas phase (air) is introduced, which accounts for 0.2% v / v to 50% v / v relative to the volume of the emulsion. To obtain the highest volume of air (10% v / v - 50% v / v), it is preferred to use the extract of egg white, saponaria officinalis, saponaria saxatilis, or the extract of agavaceae. In certain embodiments, the air is supplied at a pressure of up to 300,000 Pa.

[0060] In certain embodiments, for this emulsion preparation stage, the temperature is maintained between 20°C and 70°C.

[0061] In certain embodiments, additives that improve the stability of the emulsion can be used, such as pectin, gelatin, or potato starch, and the amount thereof is 1% relative to the mass of the emulsion.

[0062] The final composition of the above emulsion contains 5 to 7 components of different properties.

[0063] In some cases, one component performs several biological or functional functions, and in other embodiments, the component is introduced for a single purpose.

[0064] In some embodiments, for this emulsion preparation stage, the temperature is maintained between 20°C and 70°C. In other embodiments, the entire process is carried out within the said temperature range (20°C to 70°C, preferably 25°C to 50°C).

[0065] In this way, according to the specific implementation plan to be implemented, 10 variants of three-phase or four-phase emulsions can be obtained, including: aqueous phase: oil phase: gas phase; aqueous phase: oil phase: gas phase: solid suspended in the oil phase; aqueous phase: oil phase: gas phase: solid dissolved in the aqueous phase; aqueous phase: oil phase: gas phase: solid dissolved in the aqueous phase and solid dissolved in the oil phase; aqueous phase: oil phase: gas phase: solid dissolved in the aqueous phase and solid dissolved in the oil phase; aqueous phase: oil phase: gas phase: solid dissolved in the aqueous phase and solid suspended in the aqueous phase; aqueous phase: oil phase: solid dissolved in the aqueous phase; aqueous phase: oil phase: solid suspended in the aqueous phase; aqueous phase: oil phase: solid dissolved in the aqueous phase; aqueous phase: oil phase: solid dissolved in the aqueous phase and solid dissolved in the aqueous phase; aqueous phase: oil phase: solid suspended in the aqueous phase and solid dissolved in the aqueous phase.

[0066] At the same time or afterwards, the quality is prepared from seeds selected from pumpkins (Cucurbita moschata) or zucchinis (Cucurbita pepo) grown in Cuba (Características agronómicas del cultivo de la calabaza e importancia nutricional y medicinal.Monographs.https: / / www.monografias.com / trabajos55 / calabaza-cubana / calabaza-cubana). The seeds can be processed in one of the following ways: directly grinding the whole seeds; grinding after shelling; drying the whole seeds first and then grinding; grinding the whole seeds first and then baking; drying, grinding and then baking the whole seeds; drying, grinding and then baking the whole seeds; grinding after shelling and then baking; grinding after shelling, treating with brine, washing, separating and then baking; drying, grinding and then baking after shelling.

[0067] In some embodiments, the seeds are pre-soaked in hot water for 30 minutes to 50 minutes, allowed to stand for 2 hours to 6 hours, and then shelled. In other cases, to obtain a slightly salty taste or to assist the shelling process, the seeds are immersed in 4% to 6% brine (NaCl), and the ratio of the seed mass to the brine volume is 6% to 10%. When seed drying is preset as the final processing step, whether drying with the shell or for shelling, the drying temperature is between 80°C and 115°C for 30 to 60 minutes. The baking temperature of the whole seeds or shelled seeds is between 80°C and 130°C.

[0068] The seeds are ground by any known method until a particle size of 10 μm to 70 μm is reached, preferably 10 μm to 30 μm.

[0069] To obtain the final nutritional composition, a food paste macro-emulsion is formed by mixing the emulsion with the seed and oil mass. To this end, Sacha Inchi oil is added to the seed mass (40% m / m to 65% m / m relative to the total mass of the nutraceutical) in an amount of 1% m / m to 20% m / m relative to the final mass of the nutraceutical, thereby forming a seed and oil mass that accounts for 40% m / m to 70% m / m of the final mass of the nutraceutical.

[0070] The emulsion is added to the seed and oil mass in an amount of 20% m / m to 60% m / m relative to the total mass of the nutraceutical. The addition is carried out under constant or variable speed, manual, mechanized or automated constant stirring, using different mixer propeller structures to ensure uniform mixing and minimize entrained air loss. As already mentioned, the mixture is set such that the concentration of raw or roasted, shelled or whole pumpkin or zucchini seeds is 40% m / m to 65% m / m relative to the total mass of the nutraceutical.

[0071] In certain embodiments, cocoa powder is added to the mixture consisting of the emulsion and the seed and oil mass in an amount of 0.5% m / m to 9% m / m relative to the total mass of the nutraceutical.

[0072] Sometimes, coconut (Cocus nucifera) oil is added to the emulsion mixture with the seed and oil mass in an amount of 5% m / m to 20% m / m relative to the total mass of the nutraceutical (Alvarado-Ruffo K., Blanco-Imbert A., M. de la Noval-Pons B, Martín-Alonso G.M. (2018). Nursery propagation of Cocos nucifera L. Case study: Baracoa. Tropical Crops. 39(4). https: / / ediciones.inca.edu.cu / index.php / ediciones / article / view / 1487 / html), and the coconut oil is from commercial suppliers such as the Baracoa Oil Production Plant in Cuba, or obtained directly from fruits collected in the field.

[0073] In other embodiments, in addition to the above-mentioned seeds, emulsion and cocoa powder, fruit and seed masses from commercial sources or directly harvested from crops can be added in an amount of 1% m / m to 10% m / m relative to the total mass of the nutraceutical, and they are selected from the following fruits: - coconut (preferably); - Almonds (Prunus dulcis) harvested in Cuba (Ecured.Pronus dulcis.https: / / www.ecured.cu / Almendra), (Fiallo, V.R.F. (2003). Apuntes para la flora económica de Cuba VII. Especies Frutales. Revista Del Jardín Botánico Nacional, 24(1 / 2), 177–217. http: / / www.jstor.org / stable / 42597201 ); - Fruits of European hazelnut (Corylus avellana) grown by small producers in Cuba in organic plantations (Ecured.Anexo:Especies de frutales cultivadas en Cuba en la agricultura urbana.https: / / www.ecured.cu / Anexo:Especies_de_frutales_cultivadas_en_Cuba_en_la_agricultura_urbana).

[0074] In some cases, natural juices or fruit concentrates obtained from commercial suppliers or from the fruits are added to the mixture of emulsion with seeds and oil quality, in an amount of 1% m / m to 5% m / m, preferably natural grape concentrate, relative to the total mass of the nutraceutical.

[0075] In other cases, protein sources in the form of isolates, concentrates, extracts or whole powders (preferably from Moringa oleifera) are added to the emulsion mixture together with the seeds and oil quality or whey (MARTíN, C. et al. Potential applications of Moringa oleifera. A critical review. Pastures and Forages, [S.l.], v. 36, n. 2, September 2013. ISSN 2078-8452.https: / / payfo.ihatuey.cu / index.php?journal=pasto&page=article&op=view&path%5B%5D=1539), in an amount of 1% m / m to 10% m / m relative to the total mass of the nutraceutical.

[0076] In some cases, the emulsion is mixed with the remaining ingredients at a rate of 10 l / min to 200 l / min to form a food emulsion-type macroemulsion containing all the ingredients of the final nutraceutical formulation. In other cases, manual stirring is carried out until a nutraceutical macroemulsion in the form of a thick paste is obtained, or manual mixing is carried out with paddles of different materials and a coating movement is applied.

[0077] Subsequently, the macroemulsion of the nutraceutical obtained with all the ingredients is cooled, preferably at a temperature of 2 °C to 10 °C. In certain embodiments, this step is carried out at room temperature for a time interval of 5 hours to 24 hours. In other cases, the cooling is carried out on an automated production line with a ventilation tunnel that has forced cold air circulation or without a tunnel; the cooling is carried out at a shorter time interval. Once the mass has cooled, it is cut and divided into rods or portions.

[0078] The nutraceutical obtained with a solid consistency is packaged in the form of rods or nougat, or individual pieces of various shapes, with a mass of 20 g to 80 g, preferably 20 g to 40 g, more preferably 20 g to 30 g, preferably covered with waterproof paper or placed in a grease-proof container, such as in PVC. The nutraceutical is stored at a temperature of 5 °C to 40 °C, preferably 4 °C to 25 °C.

[0079] As described above, different formulations of nutraceuticals can be obtained by combining the various ingredients to ensure the expected biological effects on different therapeutic targets involved in the triggering of Alzheimer's disease, other diseases, disorders or physiological states. A single ingredient can exhibit several beneficial biological actions to prevent, stop or improve the course of a disease or metabolic disorder, or to improve general health.

[0080] In various embodiments, the nutraceutical contains 3 to 5 different sources of fatty acids, phytosterols and triacylglycerols, including the seeds of pumpkin, zucchini or combinations thereof; oil (Plukenetia volubilis) present in the emulsion or in the seed and oil mass or coconut oil added to the seed mass; soy lecithin or egg lecithin as part of the emulsion; almond and European hazelnut nuts; cocoa powder, which is added to the seed mass once introduced into the emulsion.

[0081] Thus, in all embodiments, there are compounds belonging to the following groups: fatty acids having 6 to 12 carbon atoms, such as caproic acid, caprylic acid, capric acid, and lauric acid; other fatty acids, such as linolenic acid, eicosapentaenoic acid, and docosahexaenoic acid; fatty acids having a greater number of carbon atoms, such as 9,12-octadecadienoic acid, 11,14-eicosadienoic acid, 5,8,11,14-eicosatetraenoic acid, 13,16-docosadienoic acid, 7,10,13,16-docosatetraenoic acid, 4,7,10,13,16-docosapentaenoic acid, and 8e,10e,12z-octadecatrienoic acid, 9-octadecenoic acid, 11-eicosenoic acid, 5,8,11-eicosatrienoic acid, 13-docosenoic acid, and 15-tetracosenoic acid, myristic acid, palmitic acid, Δ-9-cis-hexadecenoic acid, stearic acid, nonadecanoic acid, heptadecanoic acid; in addition, the plant sterols β-sitosterol, campesterol, stigmasterol, stigmastanol, and the triacylglycerols ECN 36 (LnLnLn), ECN 38 (LnLnL), ECN 40 (LnLLL+LnLnP+LnLnO), ECN 42 (LLL+OLLn+PLLn), ECN 44 (LLO+OOLn+LLP+POLn), ECN 46 (OOL+LnPP+PLO), ECN 48 (OOO+POO), ECN 50 (SSO).

[0082] In various embodiments, the final nutraceutical contains 2 to 8 antioxidant-active ingredients, including turmeric or pepper extract or a combination thereof; Sacha Inchi as part of an emulsion; cocoa powder, which is added to the seed mass; tequila agave juice, sisal juice, soapwort juice, Saponaria ocymoides juice, or stevia extract as part of an emulsion. In some embodiments, an extract of turmeric or pepper is combined with one or more extracts or juices of tequila agave, sisal, soapwort, or Saponaria ocymoides as part of an emulsion. In other embodiments, one or more ingredients of the above groups are combined with cocoa powder, which is added to the seed mass or the emulsion. In other embodiments, one or more ingredients of each of the above three groups are combined with stevia extract to form part of an emulsion.

[0083] The final nutraceutical composition includes 1 to 3 sources of hypoglycemic compounds selected from the seeds of pumpkin, zucchini, or a combination thereof; the seeds of coconut, which are added to the seed mass; one of the following ingredients: the juice of Agave cajalbanensis, tequila agave juice, sisal juice, soapwort juice, Saponaria ocymoides juice, or stevia extract that forms part of an emulsion.

[0084] In some embodiments, pumpkin seeds are used, and in other embodiments, zucchini seeds are used. In other formulations of the nutraceutical, pumpkin or zucchini is combined. In certain other formulations, these seeds are mixed with an oil selected from coconut.

[0085] In all embodiments, 1 to 4 different sources of antihypercholesterolemic compounds are used, selected from one of the following: Sacha Inchi oil or coconut oil, which is added to the seed mass; cocoa powder, which is added to the seed mass; soy lecithin or egg lecithin, preferably soy lecithin, and / or sisal agave fruit wine or tequila agave fruit wine, all as part of the emulsion.

[0086] Specifically, in certain nutraceutical compositions, Sacha Inchi oil is combined with coconut oil.

[0087] In other compositions, one of the above two sources is mixed with cocoa powder and soy lecithin or egg lecithin (preferably soy lecithin), and / or with sisal agave fruit wine or tequila agave fruit wine. In other embodiments, the above ingredients are combined in addition to cocoa.

[0088] To form the nutraceutical, 1 to 4 sources of anti-inflammatory compounds are selected from: stevia extract, which forms part of the emulsion; using pumpkin or zucchini seeds or a combination thereof; cocoa powder, which is added to the seed mass; pepper extract, which forms part of the emulsion; sisal agave fruit wine or tequila agave fruit wine, which also forms part of the emulsion.

[0089] In all compositions, different sources of protein are used, preferably protein sources of plant origin, selected from: the seeds of pumpkin, zucchini or a combination thereof; egg white as part of the emulsion; or a combination of a subgroup of seeds and egg white.

[0090] In some embodiments, relative to the nutraceutical, other plant protein sources in an amount of 1% to 10% can be introduced into the seed mass, particularly isolates, concentrates, extracts or whole powders in the form of soybeans, peanuts, canola seeds, pea flour, preferably from Moringa oleifera.

[0091] In other embodiments, the added protein is of animal origin, specifically, whey protein.

[0092] All nutritional formulations contain ingredients that provide vitamins in amounts sufficient to supplement their different deficiencies or maintain necessary physiological levels; among these ingredients, some have been previously mentioned, and given their percentage in the final composition, these ingredients make a unique contribution to the whole by virtue of their proportion. Pumpkin seeds provide vitamins A, K, E, and folic acid, and soy lecithin provides choline; almonds are particularly prominent in providing B1, B2, B3, B6, C, and E. Agave americana fruit wine or tequila agave fruit wine provides vitamins A, C, E, B1, B2, B3, B6, B12, folic acid, and choline. Cocoa powder provides vitamins A, B, and E.

[0093] The formulation contains ingredients that provide important minerals with biological activity, including cocoa powder providing magnesium, iron, potassium, zinc, phosphorus, sodium, calcium, copper, and selenium; the ethanol extract of turmeric provides sodium, potassium, magnesium, calcium, iron, and zinc.

[0094] Seeds of the genus Cucurbita provide nutraceuticals containing calcium, magnesium, iron, phosphorus, potassium, sodium, and zinc. Almonds, on the other hand, provide a significant level of phosphorus. Cocoa powder provides potassium, phosphorus, iron, sodium, magnesium, calcium, copper, zinc, and selenium.

[0095] The nutraceutical composition contains substances that provide sensory characteristics, such as easy chewability (effortless) and easy swallowability (not adhering to the upper digestive tract but sliding down the digestive tract), suitable for the subjects and patients who consume the composition. The ingredients that ensure these properties also have the biological functions described above.

[0096] In certain embodiments, cocoa powder masks the flavor of the turmeric extract and the deep yellow color characteristic of the extract; in other embodiments, in addition to masking the taste of the turmeric extract, Sacha Inchi oil and coconut oil impart a smooth consistency to the nutraceutical, increase adhesiveness, making the nutraceutical easier to swallow and chew; honey from Apis mellifera provides a sweet taste and a unique flavor that is acceptable to most people and increases adhesiveness. On the other hand, stevia extract provides sweetness to the composition, which eliminates or reduces the characteristic flavor of the turmeric extract.

[0097] In other cases, natural juices, concentrates, or fruit extracts are added to the seeds to replace cocoa powder or in combination with cocoa powder, including natural commercial products of grapes, citrus fruits, mint, fennel, anon, preferably grapes.

[0098] The final formulation includes ingredients containing three or more fatty acids selected from fatty acids having 6 to 12 carbon atoms. These fatty acids are present in ingredients in the final formulation that cover other biological functions but determine their role in neurodegenerative diseases, particularly Alzheimer's disease. Among these ingredients, coconut oil and Sacha Inchi oil are the most prominent.

[0099] The nutraceutical composition obtained according to the present invention is used for preventing or treating the following diseases, disorders or syndromes, but not limited to: cognitive deficiencies; Alzheimer's disease; mental, behavioral and developmental disorders, including depression; diseases, disorders or syndromes of the nervous system, such as sclerosis, ataxia, Parkinson's disease; diseases, disorders or syndromes of the digestive system, such as constipation, diarrhea, heartburn; diseases, disorders or syndromes of the immune system, such as diabetes, celiac disease, Crohn's disease; diseases, disorders or syndromes of the endocrine system, particularly diabetes and prediabetes; diseases, disorders or syndromes of the circulatory system, such as venous insufficiency; cardiovascular diseases, including ischemic heart disease, coronary artery disease, peripheral vascular disease and endocarditis; cerebrovascular diseases, such as ischemic cerebrovascular diseases; infectious and parasitic diseases; neoplastic and hematological diseases; and tiredness, fatigue and malnutrition.

[0100] In certain embodiments, the product can be consumed in the regular diet of a person without any apparent injury, disorder or disease.

[0101] The nutraceutical is administered or consumed at a frequency of 1 to 3 times a day, 20 g to 80 g each time, once a day, once every two days, once every three days, for one month, with a break of 3 to 30 days, and the administration cycle is repeated.

[0102] Hereinafter, the situation where the main components of the present invention act in a unique and distinct manner is described. In particular, those active effects not mentioned in all the previous inventions reviewed in the extensive background research are emphasized. These components will be presented with all the uses and effects described in the present invention. In addition, those components that can be used for the same purpose due to related chemical composition or common biological properties are also presented.

[0103] Turmeric extract rich in curcuminoids: - Functional effect: During the experiment, it was unexpectedly determined that this extract masked the bitterness and yerba mate flavor of the total stevia extract and lightened the color of the cocoa, reducing its intensity, so that purification of the extract was not required.

[0104] - Specific biological activities against cognitive impairment and neurological diseases: The extract can cross the blood-brain barrier and stimulate the production of brain-derived neurotrophic factor (BDNF). (Sarraf P, Parohan M, Javanbakht MH, Ranji-Burachaloo S, Djalali M. Short-term curcumin supplementation enhances serum brain-derived neurotrophic factor in adult men and women: a systematic review and dose-response meta-analysis of randomized controlled trials. Nutr Res. September 2019; 69: 1-8. doi: 10.1016 / j.nutres.2019.05.001. Epub May 9, 2019. PMID: 31279955); - The extract is responsible for the establishment of neuronal synapses, has anti-amyloid β-protein aggregation activity, effective antioxidant activity and activation of antioxidant enzymes, and effective anti-inflammatory activity, prevents lipid peroxidation, promotes the degradation of neurofibrillary fibrils and tangles in vitro, and prevents lipid peroxidation (Franco-Robles E, Campos-Cervantes A, Murillo-Ortiz BO, Segovia J, López-Briones S, Vergara P, Pérez-Vázquez V, Solís-Ortiz MS, Ramírez-Emiliano J. Effects of curcumin on brain-derived neurotrophic factor levels and oxidative damage in obesity and diabetes. Appl Physiol Nutr Metab. February 2014; 39(2): 211-8. doi: 10.1139 / apnm-2013-0133. Epub August 23, 2013. PMID: 24476477); - Curcumin reduces tau egg white phosphorylation and, as shown in current studies, improves the learning ability of laboratory animals. This is because it prevents the formation of protein dimers and their oligomerization; - The polyphenols of the present invention maintain better mental health and cognitive status, which has been confirmed in population studies and is also supported by the evidence of reduced aggregation of Aβ peptides and hyperphosphorylated Tau proteins in the hippocampus (Mazzanti G., DiGiacomo S. Curcumin and Resveratrol in the Management of Cognitive Disorders: What Is the Clinical Evidence? Molecules. 2016; 21: 1243. doi:10.3390 / molecules21091243); - The extract contains high contents of minerals such as sodium, potassium, magnesium, calcium, iron, zinc, and contains vitamins such as vitamin C, thiamine, riboflavin, niacin, B6, B12, vitamin A, vitamin D, vitamin E, vitamin K, folic acid; - Activities on general health: increase endothelial function, prevent venous coagulation, elevated blood pressure and heart attacks; it has anti-cancer properties by inhibiting angiogenesis and alleviates or prevents rheumatoid arthritis (due to its anti-inflammatory effect). (Abad, Romina del Carmen, Vasena, María Catalina. 2020. Fresh turmeric: chemical-nutritional composition, use in bakery product and sensory evaluation. https: / / rdu.unc.edu.ar / bitstream / handle / 11086 / 18668 / tesis%20completa%201462.pdf?sequence=1&isAllowed=y).

[0105] Piper extract: - Contains piperine, which is its main active ingredient. Studies have shown that due to the large amount of antioxidants contained in this ingredient, it is effective against inflammation and prevention of premature aging; - Improves the bioavailability of curcuminoids.

[0106] Plukenetia volubilis (Sacha inchi) oil: -Functional role: In the conducted experiments, it dissolves and helps curcuminoid compounds to better suspend, acts as the oil phase in the emulsion, and due to its fatty acid composition, is particularly suitable for forming nanoemulsions and microemulsions; it dissolves fat-soluble vitamins in the ingredients, including properties not previously described and detected during the invention process; the results of the experimental phase of the present invention show that this oil can be better swallowed (the nutraceutical easily passes over the palate and slides along the path towards the stomach), providing the mechanical properties required by the elderly, especially chewability (the nutraceutical of the present invention does not require forceful chewing), hardness (the nutraceutical is soft for the palate), adhesiveness, uniformity, and cohesiveness of the ingredients; it retains a certain volume of air trapped in the emulsion of 3 and 4 ingredients and the nutritional structure; it provides a taste rated as "pleasant" according to the sensory evaluation scale and unexpectedly masks the characteristic flavors (bitter aftertaste) of other ingredients (stevia extract, turmeric extract); -In different examples, it has been proven that this oil has specific biological activity against cognitive impairment and neurological diseases in a very short time. It has been found that the oil contains a large amount of polyunsaturated fatty acids, especially omega-3 fatty acids and omega-6 fatty acids; as already mentioned in the review of the prior art, these fatty acids are easily converted into docosapentaenoic acid, docosahexaenoic acid, and arachidonic acid in the organism, and they significantly intervene in the central nervous system, its development, and the elimination of toxic effects on neurons. In different implementation examples, a reduction in oxidative stress has been confirmed, and as confirmed in the present invention, an improvement in learning and cognitive abilities has been achieved for the first time in the short term; -Activity on general health: Several implemented examples show that it can reduce total cholesterol and low-density lipids in the blood; -It is known that this oil can reduce blood pressure and reduce tissue damage.

[0107] Seeds of processed pumpkins and zucchinis: -Functional role: In the original way of the present invention: it provides a solid phase that helps to determine the shape or uniformity of the nutraceutical, can form a uniform structure, in which the ingredients do not separate (the aqueous phase or the oil phase does not separate) due to its high fat absorption capacity and water absorption capacity; the oil present is introduced into the final emulsion, providing a characteristic roasted flavor acceptable to the sensory evaluation panel, masking the undesirable color (dark brown) of the turmeric extract and the bitterness of the stevia extract; -Specific biological activity against cognitive impairment and neurological diseases: Alpha-lipoic acid can penetrate the blood-brain barrier; in the conducted experiments, its antioxidant and neuroprotective effects on nerve tissue have been proven, and its anti-inflammatory effect on neuronal tissue has been detected experimentally; - Certain amounts of short-chain and medium-chain fatty acids are detected, and these fatty acids can improve mitochondrial function and neuronal energy supply, which may explain the cognitive improvement found in the tests conducted in the research included in the present invention; - The oil contained in the seeds has activities of protecting the heart, reducing blood lipids, lowering blood pressure and reducing blood sugar; - Activities for general health: anti-inflammatory effect; protein supply with a balance of essential and non-essential amino acids, as a dietary supplement; - Provide a significant concentration of tryptophan for nutraceuticals. Tryptophan is an amino acid that produces serotonin and melatonin in the body, and can relieve anxiety and insomnia symptoms in patients with neurological disorders (especially Alzheimer's disease patients).

[0108] - Anti-inflammatory activity on the prostate; regulate urinary frequency, which is very common in the elderly, partly due to cucurbitacin (-)-3-amino-3-carboxypyrrolidine; - The high zinc content can provide anti-inflammatory properties, which are crucial for the activity of thymic hormones used in the anti-inflammatory process and immune response regulators; - Provide iron, magnesium, phosphorus and phytosterols, which act as purifiers of the circulatory system and prevent cardiovascular diseases, and provide physiological amounts of boron, cobalt, iron, magnesium and potassium to nutraceuticals. Thus, the same quantity (20 g - 50 g) as the minimum daily intake can itself meet the physiological needs of the elderly; - Contain vitamins A, K and E as antioxidants, and are a natural source of folic acid, which is considered to prevent myocardial infarction and helps to fix the iron provided by other components in the nutraceuticals; - Provide fiber for nutritional and health supplements, promote the passage of active substances through the intestine, improve their absorption, prevent constipation and protect the microbiota, which has been confirmed in the experiments conducted, as the experimental animals consumed more fiber than the control group and the feces. As has been shown, these fibers stabilize the microbiota, and the deterioration of the microbiota has a crucial impact on the onset of Alzheimer's disease. (Ghosh T.S., Rampelli S., Jeffery I.B., Santoro A., Neto M., Capri M., Giampieri E., Jennings A., Candela M., Turroni S. et al. Mediterranean diet intervention alters the gut microbiome in older people reducing frailty and improving health status: The NU-AGE 1-year dietary intervention across five European countries. Gut. 2020; 69: 1218-1228. doi: 10.1136 / gutjnl-2019-319654).

[0109] - Lycopene in the pericarp has antioxidant properties and is the most active among all carotenoids. Different from other carotenoids in the composition, it does not have provitamin A properties.

[0110] Several of its qualities have been described in the publication: Lemus-Mondaca, Roberto, Marin, Jessami, Rivas, Josefa, Sanhueza, Leyla, Soto, Yasna, Vera, Natalia, and Puente-Díaz, Luis. (2019). Pumpkin seeds (Cucurbita maxima). A review of functional attributes and by-products. Revista chilena de nutrición, 46(6), 783-791. https: / / dx.doi.org / 10.4067 / S0717-75182019000600783.

[0111] Cocoa: -Functional role: It provides a smooth texture and is classified as "pleasant" according to the evaluation grade of the composition by the sensory evaluation panel; its "pleasant" taste unexpectedly masks the bitterness of stevia extract and turmeric; -Specific bioactivities against cognitive impairment and neurological diseases: Anti-inflammatory and antioxidant activities, rich in flavonoids that cross the blood-brain barrier, with effective antioxidant activity, interact with kinases (PI3, ERK), increase the expression of neuroprotective and neuromodulatory proteins, thereby increasing neuronal synapses, potentially preventing neuronal death, preventing β-amyloid peptide aggregation by inhibiting β-secretase and activating α-secretase in vitro, ensuring neuronal synapses, cognitive enhancement, and neurovascular angiogenesis; in animal models, it has been shown to prevent stroke and dementia and stop cognitive decline (David L. Katz, Kim Doughty, and Ather Ali. Cocoa and Chocolate in Human Health and Disease. Antioxidants & Redox Signaling. November 15, 2011; 15(10):2779 - 2811. doi:10.1089 / ars.2010.3697); -Activities for general health: Cardiovascular protection, general antioxidant, general anti-inflammatory, reducing cholesterol and total triglyceride levels, increasing high-density fatty acid levels.

[0112] Soybean lecithin and egg lecithin: -Functional role: Emulsifier, in the present invention, it initially acts as a foaming agent, making it possible for the first time to emulsify a complex multi-component system with at least a three-phase (oil phase, water phase, gas phase) and a four-phase (suspended solids contained in the droplets are introduced into the three-phase system) of 5 to 6 components; -Specific bioactivities against cognitive impairment and neurological diseases: The phosphatidylserine it contains helps improve the cognitive ability and memory of animal models and has a high phosphorus content; -Activities for general health: Rich in ω-3 and ω-6 essential fatty acids, reducing blood cholesterol and improving liver function; -Its combination with extracts of Saponaria, Clidemia hyrta, and Agavaceae prevents the possible hemolysis of red blood cells by these extracts, which ensures the safety of using these extracts to achieve a significant level of air entrapment in the emulsion and the final product, meaning a softer structure for easier chewing.

[0113] Juice of Agavaceae: -Contains saponins and sapogenins; -Functional role: As an emulsifier and foaming agent, and a buffer of the composition. In the present invention, it was initially used to emulsify a complex multi-component system of three or four phases (oil phase, water phase, gas phase, solid) with at least 5 to 6 components; -Specific biological activities against cognitive impairment and neurological diseases: Antioxidant, anti-inflammatory, it provides saponins and sapogenins involved in interneuronal communication and the removal of acetylcholine; provides vitamins A, C, E, B1, B2, B3, B6, B12, folic acid and choline; helps to reduce blood cholesterol levels because it contains sitosterol, which by mimicking its structure prevents its absorption at high levels; regulates the concentration of pro-inflammatory cytokines and improves cognitive function; -Activities for general health: It helps to alkalize the body, absorbs toxins at the intestinal level, provides polysaccharides, protects the intestine from bacterial and viral colonization by helping the formation of macrophages, it has anti-inflammatory activity at the intestinal level, and is an anthelmintic.

[0114] Extracts of Saponaria officinalis and Saponaria saxatilis: -Unexpected foaming ability, which allows to obtain nanoemulsions and microemulsions with a high content of soluble or suspended solids in complex three-phase, four-phase and multi-component emulsions. In addition, integrating this emulsion into an even more complex emulsion of the emulsified food type, maintaining chewability and ensuring the maintenance of the solid structure, so that the solid structure does not break or deform; -Has antioxidant properties due to its content of sapogenins and apiogenin.

[0115] Egg white: -The emulsifying and foaming ability of egg white is known. In the form, concentration evaluated and processing method established in the present invention, it is possible to obtain very stable nanoemulsions and microemulsions with a high percentage of gas phase, which makes it possible to obtain a texture that is very easy to chew and swallow; -Significantly reduces the color intensity of other ingredients, such as stevia extract, turmeric extract and chocolate powder; -Surprisingly, it provides 100% high emulsion stability for 24 days or longer; -Surprisingly, adding raw egg white to the nutraceutical composition does not affect the microbial spoilage and stability of the product, because the product has been stored under refrigeration for more than one year and has not deteriorated due to biochemical or microbial decomposition; this is due to the original innovative combination of raw egg white with other ingredients in the emulsion, and the product has strong bactericidal and antibacterial capabilities.

[0116] Stevia extract: -Used for the treatment of type II diabetes because it contains glycosides; -Calorie-free sweetening property (sweetening ability is 200 - 300 times higher than sugar); - Contributes to blood pressure control; - Hypoglycemic effect, improving glucose absorption; - Beneficial for fat absorption; - Antibacterial and antifungal properties; - Helps improve the taste caused by turmeric extract.

[0117] In some cases, adding the quality of seeds and oil to the emulsion, the quality of fruits and seeds provides flavors and odors acceptable to consumer groups, improves taste and odor, and achieves additional biological functions.

[0118] Coconut fruit and oil: - Functional roles: Its oil dissolves the fat-soluble vitamins in the ingredients, and as a result of the experimental work of the author of the present invention, it was unexpectedly determined that it enables better swallowing of nutritional supplements (it easily slides over the palate and along the path towards the stomach, and together with other ingredients ensures this phenomenon); it provides the mechanical properties characteristic of nougat, especially its chewiness (the nutritional supplement does not require forceful chewing), hardness (the nutritional supplement has a soft texture), adhesiveness, uniformity, and cohesiveness of the ingredients, maintains the amount of air trapped in the structure of the nutritional supplement, provides a characteristic coconut flavor and masks the characteristic flavors of other ingredients (stevia extract, turmeric extract); - Specific biological activities against cognitive impairment and neurological diseases: Among them, the chain fatty acids are easily converted into ketone bodies in the liver and provide alternative energy for the brains of subjects with insulin resistance in this organ; - Activities for general health: Antibacterial activity (derived from its enzymatically digested monolaurin that inhibits pathogenic viruses, bacteria, and yeasts); - Unexpectedly, it can reduce the activity of bacteria, and after being stored for one year under refrigeration conditions, the product will not decompose due to contamination; - Studies on its ingredients by the methods used show that it is rich in phenolic acids (caffeic acid, caffeic acid, p-coumaric acid, etc.) with known antioxidant activity, so it should have the effect of reducing plasma cholesterol and blood sugar levels; - Through its structure, these acids, especially ferulic acid, reduce the aggregation level of amyloid-β protein.

[0119] European hazelnut fruit: - Contains approximately 16% protein; - An important source of cholesterol-lowering, antioxidant, and anti-inflammatory substances; - High content of vitamins (such as thiamine and niacin); - Among the minerals it contains, calcium, phosphorus, magnesium, and potassium are particularly prominent; - Provides fiber and promotes digestion; - Increase neural connections and neuronal tissue; - Reduce platelet breakdown, contributing to reduced thrombus formation; - Contain unsaturated fatty acids ω-3 and ω-6.

[0120] Almond fruit: - Contain protein, fat (monounsaturated fatty acids), dietary fiber, and minerals such as calcium; - Its content in sugars and other carbohydrates is very low, not exceeding 4%; - Contain vitamins E and C; - Contain monounsaturated fatty acids, which help reduce cholesterol levels; - Antioxidant properties; - Provide a pleasant taste for nutraceuticals.

[0121] The following is a brief description of the accompanying drawings: Figure 1 Shows the particle size measurement results of the CO26 composition in the zetasizer device. X-axis: size in nm; Y-axis: intensity measured in %. V26 variant oil: water ratio = 1:1.5 v / v Figure 2 Shows the particle size measurement results of the CO27 composition in the zetasizer device. X-axis: size in nm; Y-axis: intensity measured in %. V27 variant oil: water ratio = 1:1.5 v / v Figure 3 Shows the effect of turmeric extract, pumpkin seeds, and nutraceuticals on oxidative lipid damage in brain homogenates in OF1 mice. * Significantly different from G1. + Significantly different from G2 Figure 4 Shows the effect of turmeric extract, pumpkin seeds, and nutraceuticals on total antioxidant capacity in OF1 mice. * Significantly different from G1. + Significantly different from G2.

[0122] Figure 5 Shows the results of the time spent in the arms in the Y-maze test in the closed arms in OF1 mice supplemented with variant 3 components (V3). * Significantly different from G1. + Significantly different between the closed arm and the other arms in the same group (p < 0.05).

[0123] Figure 6 Discloses the latency results in the quadrant where the target platform is located in the Morris water maze test in male OF1 mice, which were supplemented with V5 variant components (G3) for 5 weeks. G1 is the young control group, and G2 is the group of old animals gavaged with the vehicle (10% Tween-20 dissolved in 0.9% NaCl). * Significantly different from G2.

[0124] Figure 7 Shows the results of the Y-maze test of OF1 mice after 5 weeks of oral nutritional supplements. A) Number of entries. B) Percentage of alternations. Analysis of variance and Tukey's post hoc test were used (p < 0.05). *Significant difference compared with G1. +Significant difference compared with G2.

[0125] Figure 8 Shows the experimental results of the latency in the passive avoidance test (24-hour stay) of OF1 mice evaluated after 5 weeks of oral nutritional supplements. A) Acquisition phase. B) Stay phase. Analysis of variance and Tukey's post hoc test were used (p < 0.05). *Significant difference compared with G1. +Significant difference compared with G2.

[0126] Figure 9 Shows the effects of coconut oil, Sacha Inchi oil, turmeric extract, and nutritional supplements on the serum glucose levels of male OF1 mice. *Significant difference compared with G1 group and G2 group (p < 0.05).

[0127] Figure 10 Shows the experimental results of determining the effects of nutritional supplements and coconut oil on the serum cholesterol and triglyceride levels of male OF1 mice. *Significant difference compared with G2 group (p < 0.05).

[0128] Figure 11 Shows the thermal response time of male OF1 mice in the hot plate test. Different letters a, b indicate differences between groups (p < 0.05).

[0129] The following are several implemented examples: Example 1 This example shows how to obtain the main components of the nutritional supplement, which will be part of different examples of the final formulation. It also shows the components that make up the emulsion and the composition and basic properties of the components of the nutritional supplement that support the core essence of the present invention.

[0130] Testing fatty acid composition The fatty acid content of all fatty acid-producing raw materials included in the claims was evaluated by gas chromatography (Tables 1, 2, and 3).

[0131] It can be seen that all the components provide fatty acids that play a biological role in nutritional health products, and it is demonstrated that they respond to the compositions shown in the claims, as they provide medium-chain fatty acids ω-3, ω-6, and ω-9 in their combination, as well as those fatty acids that enable the stability of the emulsion. Additionally, raw materials containing phytosterols and triacylglycerols are used. The combination of these fatty acids is novel and flexible, achieving a high degree of complementarity by combining the sources of at least 2 or 3 of the claimed groups.

[0132] For example, a nutritional variant combines coconut oil with pumpkin oil, soy lecithin (in the emulsion), turmeric extract (in the emulsion), and Sacha Inchi oil (in the emulsion).

[0133] In another variant, zucchini seeds are combined with the other fatty acid sources described. A new nutritional variant is formed using the first combination described in this paragraph, but using egg white instead of soy lecithin.

[0134] Another example consists of the combination of the first variant described in the previous paragraph (coconut oil with pumpkin oil, soy lecithin, turmeric extract, and Sacha Inchi oil), but with the addition of cocoa butter.

[0135] Table 1. Fatty acid composition of nutritional health product components Fatty acid Coconut oil, sample 1 (%) Coconut oil, sample 2 (%) Coconut oil, industrial sample (%) Cocoa butter (%) C8：0 6.17±0.12 5.17±0.06 5.57±0.15 - C10：0 5.43±0.12 4.87±0.06 5.30±0.0 - C12：0 43.47±0.55 42.70±0.46 44.20±0.10 - C14：0 16.10±0.36 17.63±0.15 16.80±0.10 - C16：0 8.13±0.15 0.17±0.06 0.47±0.10 19.43±0.21 C16：1 0.03±0.02 8.57±0.06 7.93±0.12 0.20±0.00 C18：0 2.50±0.00 2.57±0.15 2.30±0.00 25.17±0.42 C18：1 6.77±0.12 6.20±0.10 6.50±0.10 24.90±0.56 C18：2 1.83±0.06 2.27+0.06 2.87±0.29 2.07±0.12 C18：3 0.08±0.04 - - - C20：0 - - - 0.73±0.06 C20：1 - - - - Total 90.50±1.00 90.27±0.91 91.97±0.15 72.47±1.27

[0136] Table 2. Fatty acid composition of nutritional health product components Fatty acid Soybean lecithin (%) Plukenetia volubilis oil (%) C8：0 - - C10：0 - - C12：0 0.05±0.05 - C14：0 0.13±0.06 0.13±0.06 C16：0 11.33±0.12 0.27±0.12 C16：1 0.08±0.03 4.33±0.06 C18：0 3.23±0.06 2.73±0.21 C18：1 11.57±0.57 10.83±0.23 C18：2 35.93±0.25 34.47±0.46 C18：3 4.17±0.06 44.63±0.12 C20：0 - - C20：1 - - Total 66.43±0.42 97.43±0.78

[0137] Table 4 shows the presence of phytosterols, triacylglycerols, monoacylglycerols, diacylglycerols, and triglycerides measured in the raw materials.

[0138] Table 3. Fatty acid composition of nutritional health product components Fatty acid Roasted pumpkin seeds, (%) Fatty acid Roasted pumpkin seeds, (%) C8：0 - C17：0 26.44±0.55 C10：0 - C18：0 6.33±0.99 C12：0 0.00580±0.0017 C18：1 36.79±0.73 C13：0 0.04453±0.0069 C18：2 45.78±0.83 C14：0 - C18：3 0.28±1.35 C15：0 0.00486±0.0010 C19：0 0.00972±0.00051 C16：0 10.12±0.05 C20：0 0.34±0.66 C16：1 0.04376±0.00239 C20：1 0.03513±0.0005 C24：0 0.02133±0.0069

[0139] All the examples cited above ensure the presence of the fatty acids, phytosterols, and triacylglycerols described in at least three groups selected and described in the present invention, and ensure the original combination of biological effects for the most diverse pathologies and disorders usually involving lipids, highlighting the effects on neuronal diseases and disorders, including Alzheimer's disease.

[0140] It has been proven that even after baking, pumpkin seeds still retain a saturated fatty acid content of 16.79 ± 2.5%, a monounsaturated fatty acid content of 37.15 ± 1.6%, and a polyunsaturated fatty acid content of 46.06 ± 1.8%. As confirmed by the patent, this composition can provide fatty acids that complement the fatty acids provided by other ingredients in nutraceuticals. Specifically, the presence of pentadecanoic acid (C:15), margaric acid (C17:0), nonadecanoic acid (C19:0), and lignoceric acid (C24:0) fatty acids has been determined, which confirms the claims of the present invention.

[0141] Table 4. Composition of phytosterols, triacylglycerols (molecular species), and other fatty acids in the ethanol extracts of Plukenetia volubilis oil and turmeric Fatty acid Plukenetia volubilis oil (%) Curcumin glycolic acid (%) β - Sitosterol 0.06114 - Campesterol 00.424 - Stigmasterol 0.02522 - Stigmastenol 0.0183 - ECN 36 (LnLnLn) 23.3 - ECN 38 (LnLnL) 25.8 - ECN 40 (LnLL + LnLnP + LnLnO) 20.1 - ECN42 (LLL + OLLn + PLLn) 20.3 - ECN44 (LLO + OOLn + LLP + POLn) 7.6 - ECN 46 (OOL + LnPP + PLO) 2.5 - ECN 48 (OOO + POO) 2.1 - ECN 50 (SSO) 1.2 - Total triglycerides - 2.3 Total diglycerides - 3.6 Total monoglycerides - 1.2

[0142] In this example, it is obvious that the combination of fatty acid sources of the present invention provides a nutraceutical composition with a diversity in nutraceutical products from natural sources that has never been described before. Specifically, coconut oil and pumpkin oil provide medium-chain fatty acids; soy lecithin, Plukenetia volubilis oil and coconut oil, cocoa oil, and pumpkin seeds provide long-chain fatty acids up to C18:2. Soy lecithin and Plukenetia volubilis oil provide C18:2 and C18:3 fatty acids, while pumpkin seeds provide heavy-chain fatty acids up to C24. Finally, Plukenetia volubilis oil provides phytosterols and triacylglycerols.

[0143] In addition, based on the relationship between these minerals and the development of Alzheimer's disease, the iron, copper, zinc, magnesium, and calcium contents of the raw materials coconut oil and soy lecithin were determined (Myhre O, Utkilen H, Duale N, Brunborg G, Hofer T. Metal Dyshomeostasis and Inflammation in Alzheimer's and Parkinson's Diseases: Possible Impact of Environmental Exposures. Oxidative Medicine and Cellular Longevity, 2013. ID 726954, 19 pp. doi.org / 10.1155 / 2013 / 726954). The results are shown in Table 5, which confirms the contribution of the raw materials used in the present invention to trace elements and macroelements as claimed.

[0144] Table 5. Mineral contents in some raw materials native to this country

[0145] The total number of microorganisms in these samples was also determined (Table 6). It can be seen that the raw materials tested comply with the microbial standards for use in food.

[0146] Table 6. Total number of microorganisms in some raw materials used in nutraceuticals

[0147] Other quality indicators of the nutritional components (such as pH, loss on drying or total solids) are characteristics of solid nougat-like or bar products and ensure durability (Table 7).

[0148] Table 7. Other indicators of some raw materials that produce fatty acids

[0149] It should be noted that the acid number values of the lipid compound sources used in the present invention do not show evidence of their deterioration. In all cases, this value is lower than the value required by the Codex Alimentarius for edible fats (4 mg KOH / g oil); some examples of these values are shown below (Table 8).

[0150] Table 8. Acid number of some oils used Raw material Acidity index, 4mg KOH / g oil Plukenetia volubilis oil 0.78 Coconut oil 1.45

[0151] Stevia extract was obtained.

[0152] Experiment 1: Take 200 mL of water and 20 g of pre-dried stevia leaves, mix and shake at a speed of 3001 / min at a temperature of 60 °C for 3 hours. Centrifuge the extract to separate the solids. Take 100 mL from the supernatant, add 7.35 g of zeolite, shake for 15 minutes and let stand. Then filter through a filter plate. An extract with a refractive index of 1.343 was obtained. The stevia was from the El Pitirre Farm in the Pinar del Rio province of Cuba.

[0153] Experiment 2: Similar to the previous experiment, but using activated carbon instead of zeolite.

[0154] An ethanol extract of turmeric was obtained. The storage roots of this plant were obtained from the Medicinal Plants Farm in the city of Güines, Cuba and the farm in the city of Arroyo Naranjo.

[0155] Experiment 1: Take 28 kg of turmeric roots, wash them with water, drain, wash with chlorinated water (0.5% chlorine solution), rinse with running water, and drain. Grind the roots in a knife mill and place them on trays at a rate of 2 kg per tray, then place them in a convection drying oven at 80 °C for 10 hours; thus obtaining a humidity of 7%. Obtain 5 kg of the product and crush it in a high-speed blade mill; obtain 4.5 kg of turmeric powder with a water content of 10.05%. Take 200 g of the obtained powder, add 1000 mL of 95% ethanol, shake at 60 °C for 4 hours to obtain an extract; centrifuge the extract at 4300 rpm for 30 minutes to remove the precipitate, and concentrate the supernatant under vacuum at the same temperature to obtain 20 g of a concentrate with a total solid content of 46%. The obtained pH is 4.3.

[0156] Qualitative determination was carried out on most of the components of the obtained extract. For this purpose, the experimental extract was compared with a control commercial extract obtained from Portuguese turmeric roots by thin-layer chromatography. Chloroform: methanol (95:5) was used as the mobile phase and silica was used as the stationary phase. It was proved that the three main components (curcumin, demethoxycurcumin, bisdemethoxycurcumin) in the turmeric extract were all present in the extract. In addition, a standard curve of curcumin dissolved in acetone with a concentration of 1 μg / mL to 6 μg / mL was prepared, and the absorbance was read at 425 nm. This curve allows the quantification of the concentration of curcuminoids in the extract obtained on a laboratory scale, which is 16.81 mg / g of turmeric powder, representing 2% of curcuminoids in the turmeric powder raw material. Literature reports that in Indian turmeric cultures, curcuminoids account for 2.3% to 9.2%. One of the components of the nutraceutical with antioxidant effect claimed in the present invention is the turmeric extract. The concentration of curcuminoids in this extract is 8.43 mg / mL.

[0157] Experiments 2 and 3: Similar to Experiment 1; obtain two batches of turmeric powder with humidities of 10.05% and 6.11% respectively, extract humidities of 20.45% and 12.9% respectively, and pH values of 4.4 and 4.3 respectively. The concentrations of curcuminoids are 8.43 mg / mL and 9.7 mg / mL respectively. The storage roots of the plant were obtained from the Liliana Dmitrova Institute in the Mayabeque Province of Cuba.

[0158] Experiment 3: Prepare a new batch of extract according to the above procedure. The results are shown in Table 9.

[0159] Experiment 4 (industrial scale): Take 11 kg of turmeric powder and process it as described in the previous experiment. In a reactor, mix the powder with 110 L of 95% ethanol, heat at 60 °C for 4 hours, and apply vacuum to evaporate the ethanol and concentrate the extract. The concentration of curcuminoids in this extract was 17.51%, including: 9.12% curcumin; 5.21% demethoxycurcumin; and 3.18% bisdemethoxycurcumin. Additionally, it contained 3.3% triglycerides, 3.6% diglycerides, and 1.2% monoglycerides.

[0160] Table 9. Turmeric extract

[0161] Obtain a hydroalcoholic extract of turmeric Similar to the ethanol extract of Experiment 4, but without using ethanol, instead using a 70% aqueous ethanol solution, with the remaining parameters remaining unchanged. Concentrate the product until the above-mentioned level of curcuminoids is reached.

[0162] Obtain emulsifiers and foaming agents The presence of air in oral products aids the swallowing process and helps form a structure with lower hardness and chewiness, which is an important aspect of nutritional supplements for the elderly. In this case, the air forms part of the emulsion and is generated by using emulsifiers.

[0163] In the present invention, ingredients that have never been described as emulsifiers before, such as extracts of Agave fourcroydes and Agave tequilana, are used because they contain saponins. Strong agitation of the extracts of these ingredients not only introduces air into the emulsion but also creates flow in its aqueous matrix, dragging large protein molecules that may be present, such as in egg white. If this flow is strong enough, it can unravel some of the less stable amino acid tangles, forcing them to lose their original structure and expose their hydrophobic regions outward.

[0164] Due to the bubbles being close to each other, the denatured proteins and other components of the emulsion are adsorbed at the water-air interface, with their non-polar regions facing the inside of the bubbles and their polar regions facing the aqueous matrix, which greatly reduces the surface tension of the bubbles, enabling them to act as effective surfactants. Foaming is a thermodynamically unfavorable process that requires the input of energy in the form of mechanical agitation. The nutritional supplement ingredients claimed in the present invention incorporate air into the final product mixture, which improves its chewiness and also makes its texture softer.

[0165] Agave fourcroydes: Process the leaves and fruits of two henequen clones obtained from the Liliana Dmitrova Institute in Quivicán, Cuba. Wash, chop, and grind them in a pilot sugarcane grinder. The following is a summary of the yields in Table 10.

[0166] Take 20 liters of samples from each clone. It is believed that, despite the low juice yield shown, sufficient foam expansion values can be obtained.

[0167] Table 10. Mass production to obtain Agave fourcroydes extract

[0168] The processing method of Agave tequilana is similar to that of Agave fourcroydes.

[0169] For every 100 g of leaves, add 2000 mL of water, heat to 65 °C, oscillate at a speed of 800 l / min for 4 hours, pour out the residue, and filter the supernatant. A dark, slightly milky extract is obtained, with a total solid content of 1.2% to 5% and a pH of 4.9. Even if the concentration is not very high, the foaming of the extract can be ensured. Considering that the solid percentage is very low, these values are already very high, and it is ensured that the extract can be added to nutraceuticals at different concentrations and higher volumes to obtain very stable foam (the foam affects the sensory quality of the product, especially chewiness), and enables the formation of a four-phase emulsion including the gas phase.

[0170] Egg white as an emulsifier-foaming agent The overrun is also a parameter characterizing the emulsifier, which is calculated by the following formula:

[0171] where: V A = V E - V L ; V A is the volume of air introduced into the foam; V E is the volume of the foam, and V L is the volume of the liquid.

[0172] When the ratio of egg white to water is 0.5:1 and no additional emulsifier is present, keep stirring for 1 to 3 minutes, and the overrun value is very high (83.3), and the foam expansion value is also very high (183.3%).

[0173] Soybean lecithin The purpose of this group of experiments is to determine the possibility of obtaining an emulsion from Plukenetia volubilis oil using soybean lecithin as an emulsifier.

[0174] Three emulsion compositions (1, 2, and 3) were tested in a blender using different concentrations of lecithin as an emulsifier: oil, water, and lecithin were placed in the blender at the desired concentration, and the stirring process was carried out for 2 minutes; the speed of the blender was 12,500 1 / min. The formed emulsion was poured into a 100 mL graduated cylinder, and the amount of emulsified oil and the stability of the emulsion were evaluated after 30 minutes.

[0175] - Composition 1 (water:oil:lecithin ratio = 1:1:0.016 V / V) - Composition 2 (water:oil:lecithin ratio = 1:1:0.012 V / V) - Composition 3 (water:oil:lecithin ratio = 1:1:0.008 V / V) Water:oil ratio: 1:1 (30 mL water: 30 mL oil) It can be seen that for all lecithin concentrations used, the foaming ability is very high, and for the composition including 1% lecithin, the foaming ability reaches 100%. After 30 minutes, the emulsion stability of all variants is 100%.

[0176] The use of egg lecithin is similar because it has the same properties and characteristics as soy lecithin.

[0177] Table 11. Quality indicators of emulsions obtained using soy lecithin as an emulsifier

[0178] Microemulsion compositions and nanoemulsion compositions were obtained.

[0179] Using Sacha inchi oil as the oil phase, water as the water phase, and soy lecithin as the emulsifier, several oil-in-water emulsions were formed.

[0180] Compositions CO24, CO25, CO28, and CO29 were made from soy lecithin, while CO26, CO27, CO30, and CO31 were made from egg white. The compositions CO24, CO26, CO28, and CO30 were formed using a phase ratio of 1:1; in compositions CO25, CO27, CO29, and CO31, the ratio of the oil phase to the water phase was 1:1.5. The stirring speed of compositions CO28, CO29, CO30, and CO31 was 12,500 1 / min, and the rest (CO24, CO25, CO26, CO27) was 15,000 1 / min. The emulsion measurement times were 30, 60, and 90 minutes. As a result, 100% emulsification and stability were obtained at all measurement times, except that compositions CO30 and CO31 obtained stabilities of 99.15% and 97% after 60 minutes.

[0181] These experiments show that, according to the present invention, the basis for forming the emulsion ensures the formation of a stable composite emulsion.

[0182] Since visual observation of the emulsion properties is not sufficient to characterize it, we continued the observation under an optical microscope. When observing samples of compositions CO25, CO24, and CO28, spherical droplets with uniform size and well-formed shape can generally be seen. It is understood that the particle sizes of CO24 and CO28 are approximately 1 μm and 2 μm, respectively. For composition CO25, the particle size is between 3 μm and 7 μm. The sizes achieved are due to the energy consumed at the tested stirring speeds, especially in CO28, where shear may occur and manage to reduce the droplet size to the sub-micron range. In the studied area, the uniformity of the size distribution was observed, indicating the absence of flocculation.

[0183] Figure 1 The droplet size distribution measured in the Z-ziser (laser beam scattering scanning) of composition CO21 is shown, where an average majority size less than 1 micrometer (1 μm) was observed. Figure 2 The size of composition CO27 is shown, and an emulsion with droplet sizes in the nanometer range (100 - 200 nm) can be obtained using this composition. These evidences indicate that the components dissolved or suspended in the oil phase and the water phase will have higher bioavailability in living organisms. This phenomenon has been widely described (Zou L.; Liu, W.; Liu, C.; Xiaob, H.; McClements D.J. (2015). Designing excipient emulsions to increase nutraceutical bioavailability: emulsier type inuences curcumin stability and bioaccessibility by altering gastrointestinal fate. The Royal Society of Chemistre. DOI: 10.1039 / c5fo00606f).

[0184] Processing of zucchini and pumpkin seeds. These seeds were obtained from seed companies in the Mayabeque and Artemisa provinces of Cuba.

[0185] Experiment 1: 1000 g of seeds were baked to obtain 700 g, ground, mixed with water (280 mL), decanted, the shells floating on the surface were removed, the seeds were separated with a sieve, drained, and dried in an oven at 70 °C to a humidity of 11%.

[0186] Take 100 g and grind in two types of grinders: a plastic cup and steel blades, and a sterilizable glass and steel blades.

[0187] Add 400 mL of water and decant for 2 hours. Screen the samples (250 mm) and drain for 5 minutes, obtaining weights of 122 g and 123 g, with no difference between the types of grinders used. The precipitates are dried in an oven at 70 °C for 1.19 hours and 1.49 hours, respectively. The total yields of grains and seeds are 53 g / 100 g and 54 g / 100 g, respectively. The drying loss values are 8.28% and 5.97%, respectively, which allows for their preservation.

[0188] Table 12. Composition of whole and dehulled unroasted seeds

[0189] Experiment 2: Take 2000 g of zucchini seeds, roast them in a cast iron container to obtain 1952 g of roasted seeds (yield 97.6%). Grind them in a plastic cup mill, mix with 800 mL of water, and let stand for decantation for 1 hour. Separate the precipitate with a sieve and let it drain. The weight of the drained wet seeds is 2083 g.

[0190] Dry in a convection oven at a temperature of 80 °C - 90 °C for 6 hours. The final yield of shellless seeds is 1099 g, with a yield of 50%. Grind the material and pass it through a 1 mm sieve to obtain 804 g of roasted, dried, and ground seeds (yield 40.2% relative to the original seed mass). The dehydration rate is 2.88%. The protein content is high (32%).

[0191] Oil absorption capacity and water absorption capacity of pumpkin seeds.

[0192] Including seeds in nutraceuticals is not only aimed at providing proteins of plant origin with anti-inflammatory activity and medium-chain fatty acids, as well as other compounds with antioxidant activity, but also at ensuring the absorption of other ingredients such as oil emulsified in water. Therefore, determining the water absorption capacity and oil absorption capacity of this raw material is of interest.

[0193] The oil absorption capacity is determined as follows: Add 20 mL of oil to 2 g of the sample in a 50 mL centrifuge tube and shake in a vortex-type shaker for 1 minute at room temperature. Centrifuge the mixture at 2100 g for 30 minutes. The result is expressed as the grams of oil retained per gram of sample.

[0194] The oil absorption capacity is calculated according to the following formula: where CAAc - oil absorption capacity, g / g; MIAc – initial mass of oil, g MFAc - final mass of oil after centrifugation, g; MM - sample mass, g Water absorption capacity The water absorption capacity was determined in a similar manner: 20 mL of water was added to 2 g of the sample in a 50 mL centrifuge tube and shaken in a vortex shaker for 1 minute at room temperature. The mixture was then centrifuged at 2100 g for 30 minutes. The result was expressed as the number of grams of water retained per gram of sample.

[0195] The water absorption capacity was calculated according to the following formula: where CAA - Water absorption capacity g / g MIA - Initial mass of water, g MFA - Final mass of water after centrifugation, g MM - Mass of sample, g Both the water absorption and oil absorption of the unhulled seeds showed sufficient values (Table 13).

[0196] Table 13. Oil absorption capacity and water absorption capacity of unhulled seeds

[0197] CAAc: Oil absorption capacity; CAA: Water absorption capacity In the case of oil absorption, the treated seeds obtained a value of 0.74 g of oil per g of sample, while in the case of water, approximately 50% of their weight was absorbed. The results obtained from the seeds ensure that they can play the expected role in the final nutraceutical (providing fatty acids that can be absorbed by quality, emulsified with water and do not show separation phenomena), and endow the final product with these unique and novel properties mentioned above. It should be noted that this type of product, according to its function, can be classified as a nutraceutical, and due to its properties, it can also be considered a functional food.

[0198] Amino acid composition of pumpkin seeds According to the present invention, the composition of the seeds is due to the presence of essential amino acids (Table 14).

[0199] Table 14. Amino acid content of shelled, roasted and ground pumpkin seeds

[0200] These results indicate that the technological processing does not affect its content. This example shows the content of tryptophan, an essential amino acid for many functions of the central nervous system.

[0201] The seeds have a low carbohydrate content, which is beneficial for organisms to absorb medium-chain fatty acids in the nutraceutical, convert them into ketone bodies, which are the only alternative source of neuronal energy support for patients with Alzheimer's disease and other diseases related to insulin resistance at the brain level. It is thus obtained that: fructan 4.85% ± 0.13%, sucrose 3.18% ± 0.10%, glucose 1.74% ± 0.07%.

[0202] In another variant, by adding Apis mellifera honey, the nutraceutical can be used for other conditions or diseases, or generally as a nutritional support contributing carbohydrates by increasing the fructose content to 41.8% and the glucose content to 34.6%.

[0203] In another variant, by adding sugar, the nutraceutical can be used for other conditions or diseases, or generally as a nutritional support for subjects without diabetes or at risk of developing diabetes due to carbohydrate intake by increasing the sucrose content to 100 g / 100 g.

[0204] Table 15 shows the vitamin content results of the main vitamin components in the nutraceutical. Although this is not the only result, this result ensures an important level of vitamins, which play an important role in preventing or treating various diseases, especially Alzheimer's disease and memory disorders caused by other disorders or diseases, among which B12, C, D, E, B6, and folic acid are particularly prominent.

[0205] The diversity of vitamins provided by the components of the nutraceutical allows it to be used in the treatment of nutritional disorders such as vitamin deficiencies, fatigue, stress, and other conditions.

[0206] Table 15. Vitamin content in hulled, roasted, and ground pumpkin seeds obtained according to the present invention Vitamin UI / 100g mg / 100g μg / 100g Retinol acetate (A) 6.1 Cholecalciferol (D3) 0.001 Thiamine (B1) 0.5 Riboflavin (B2) 0.18 Niacinamide (B3) 5.2 Pyridoxine (B6) 0.1 Biotin (B7) 0.002 Folic acid (B9) 58.5 Cyanocobalamin 0.03 Vitamin C 11.3 α - Tocopherol (E) 2.2 Menadione (K3) 7.3

[0207] Example 2 Nutraceutical Variant 1 (V1) Prepare 2800 g of the nutraceutical Preparation of the emulsion components: To prepare the emulsion, an aqueous liquid phase consisting of 250 g of water (equivalent to 8.93% m / m of the nutraceutical) was selected and heated to 100 °C. 780 g of sucrose (sugar) was added as a sweetener (equivalent to 27.86% m / m of the nutraceutical), and it was stirred until completely dissolved, and the temperature was brought to 40 °C. Soybean lecithin was selected as the emulsifier (5 g, representing 0.178% m / m relative to the total mass of the nutraceutical).

[0208] The components are stirred and mixed at a stirring speed of 15,000 1 / min to obtain a microemulsion. When the components are stirred, a gas phase (air) is introduced, which represents 19% v / v of the emulsion and 8.8% of the total volume of the nutraceutical. At this preparation stage, the emulsion is maintained at a temperature of 25 °C.

[0209] Subsequently, an emulsion oil phase containing soluble solids is prepared. In this case, the soluble solids are an ethanol extract of turmeric. The oil phase consists of 250 g of Plukenetia volubilis oil (8.93% m / m relative to the emulsion mass) and 15.05 g of an ethanol extract of turmeric (0.54% m / m relative to the nutraceutical mass). At this preparation stage, the emulsion is maintained at a temperature of 25 °C. In this way, a four-phase emulsion variant is obtained (aqueous phase, oil phase, air, and suspended or dissolved solids), specifically: aqueous phase: oil phase: gas phase: solids suspended in the oil phase.

[0210] At the same time, the mass of pumpkin seeds is prepared. The seeds are shelled, ground, and roasted. The seeds are removed at a temperature of 80 °C for 60 minutes. The roasting of the seeds is carried out at a temperature of 130 °C. The seeds are ground in a blade mill to obtain particles with a size between 10 μm and 30 μm.

[0211] The emulsion is mixed with the mass of seeds to form a macroemulsion of the food paste type. An amount of 1423.05 g (48.7% m / m relative to the total mass of the nutraceutical) of the emulsion is added to the mass of the shelled seeds that have been roasted and ground (1500 g, representing 60% m / m of the nutraceutical mass). The addition is carried out under manual stirring to ensure uniform mixing and minimize the loss of entrapped air. The final emulsion composition of this V1 nutraceutical variant contains six components of different natures (water, air, oil, sugar, soy lecithin, and turmeric extract).

[0212] In this variant, more than one component performs various biological or functional functions, including Plukenetia volubilis oil, turmeric extract, and soy lecithin, as described for each component above.

[0213] The obtained nutraceutical is in the form of a bar, cut into individual pieces with a mass of 40 g, covered with waterproof paper, and stored at a temperature of 10 °C.

[0214] Variant V1 contains three different sources of fatty acids, phytosterols, and triacylglycerols, including pumpkin seeds, Sacha Inchi oil, and soy lecithin. The final nutritional product (V1) contains three ingredients with antioxidant activity, including pumpkin seeds, turmeric extract, and soy lecithin, as part of the emulsion. The final composition of this nutraceutical includes a source of hypoglycemic compounds, particularly pumpkin seeds. In this variant V1, different sources of antihypercholesterolemic compounds are used, particularly Sacha Inchi oil and soy lecithin. To produce this nutraceutical, a source of anti-inflammatory compounds is used, including the anti-inflammatory compounds contained in pumpkin seeds.

[0215] In the composition of Variant V1, a protein source of plant origin is used, such as pumpkin seeds. The formulation of the V1 nutraceutical contains ingredients that provide vitamins, macronutrients, and micronutrients in amounts sufficient to supplement their different deficiencies or maintain the necessary physiological levels, particularly pumpkin seeds that provide vitamins A, K, E, and folic acid; soy lecithin that provides choline; an ethanol extract of turmeric that provides sodium, potassium, magnesium, calcium, and iron. The nutraceutical composition contains substances that provide suitable sensory properties for the subjects and patients consuming the composition, such as Sacha Inchi oil, which, in addition to masking the taste of the turmeric extract, imparts a pleasant consistency to the nutraceutical, increases adhesiveness, makes the nutraceutical easier to swallow, and facilitates chewing. On the other hand, the sucrose used provides sweetness to the composition, which eliminates or reduces the characteristic flavor of the turmeric extract.

[0216] In the final formulation, Sacha Inchi oil is included. Sacha Inchi oil contains fatty acids with 6 to 12 carbons, and ketone bodies are obtained from Sacha Inchi oil. When Alzheimer's patients face insulin resistance, the ketone bodies provide energy for neurons. The nutraceutical composition obtained according to the results of V1 and Example 1 can be used for the prevention or treatment of diseases, disorders, or syndromes, including: cognitive deficits such as Alzheimer's disease; mental, behavioral, and developmental disorders, including depression and neurological disorders; all of which are related to the presence of medium-chain fatty acids and omega fatty acids, ingredients with antioxidant, anti-inflammatory, and hypoglycemic activities, and zinc, calcium, and vitamins (particularly A, B, and C).

[0217] Similarly, due to the vitamins, proteins, antibacterial, antifungal, anthelmintic, and lipid compounds of the nutraceutical, the nutraceutical can be used to treat digestive system diseases. Due to the presence of zinc in certain amino acids, particularly tryptophan, in the nutraceutical, as well as the anti-inflammatory substances and other bioactive elements in its ingredients, it is used to treat diseases and disorders of the immune and endocrine systems. Due to the ability of the ingredients and the product itself of the nutraceutical to lower triglycerides and cholesterol, in addition to the above factors, it is also used for circulatory system, cardiovascular, and cerebrovascular diseases.

[0218] Since the nutritional health product contains antibacterial, antifungal and anthelmintic compounds in its ingredients and its stability has been confirmed, it can be used to treat bacterial, fungal and parasitic infections. Due to the amino acid composition, trace elements and macro elements, vitamins and antioxidants, and other ingredients of this nutritional health product, it is used to treat tumors and blood diseases. Generally speaking, due to the content of its fat, carbohydrates, proteins, vitamins and minerals, it is strongly recommended for combating fatigue, tiredness and malnutrition.

[0219] It is recommended to consume this nutritional health product twice a day, 40 g each time, once every two days for one month, take a rest for 3 to 30 days, and repeat the application cycle.

[0220] The different evaluation results of the nutritional health product obtained according to Variant 1 are as follows.

[0221] Chemical composition of the nutritional health product The evaluation results of trace elements and macro elements are shown in Table 16.

[0222] Table 16. Composition of trace elements and macro elements of the nutritional health product

[0223] It can be seen that the mineral content is within the range of products aimed at providing the body with sufficient doses of trace elements and macro elements. Especially zinc, whose content is necessary for the treatment of Alzheimer's disease.

[0224] Nutritional Variant 2 (V2) Prepare 2253 g of the nutritional health product Preparation of the emulsion ingredients: To prepare the emulsion, an aqueous liquid phase composed of stevia extract as a sweetening agent is selected. It contains stevioside dissolved in water (187 g of extract diluted in 63 g of water) (corresponding to 11.1% m / m of the nutritional health product), and 110 g of water is added (corresponding to 4.88% m / m of the nutritional health product). The extract is obtained as described in Example 1 (Experiment 2 for obtaining stevia extract). Generally speaking, it includes putting the pre-dried leaves into water, mixing, oscillating at 60 °C for 3 hours, centrifuging, adding activated carbon, oscillating, standing still and filtering.

[0225] Add 128 g of egg white (5.68% m / m relative to the mass of the nutritional health product) as an emulsifier and at the same time as a foaming agent.

[0226] Stir and mix the ingredients at a stirring speed of 15000 1 / min to obtain a microemulsion. When stirring these ingredients, the gas phase (air) is introduced at 30% v / v of the emulsion volume, which represents 10% of the total volume of the nutritional health product. At this preparation stage, the emulsion is kept at a temperature of 25 °C.

[0227] Subsequently, an emulsion oil phase containing soluble solids was prepared. In this case, the soluble solids were an ethanol extract of turmeric. The oil phase consisted of 250 g of Plukenetia volubilis oil (11.1% m / m relative to the mass of the emulsion) and 15.05 g of the ethanol extract of turmeric (6.64% m / m relative to the mass of the nutraceutical). At this preparation stage, the emulsion was maintained at a temperature of 25 °C.

[0228] In this way, a four-phase emulsion variant (aqueous phase, oil phase, air, and suspended or dissolved solids) was obtained, specifically: aqueous phase: oil phase: gas phase: solids dissolved in the aqueous phase and solids suspended in the oil phase.

[0229] Meanwhile, the mass of pumpkin seeds was prepared. The seeds were shelled, ground, and roasted. The seeds were taken out at a temperature of 80 °C for 60 minutes. The roasting of the seeds was carried out at a temperature of 130 °C. The seeds were ground in a blade mill to obtain particles with a size between 10 μm and 30 μm.

[0230] The emulsion was mixed with the mass of seeds to form a macroemulsion of the food paste type. 753.05 g of the emulsion (33.42% m / m relative to the total mass of the nutraceutical) was added to the mass of shelled seeds that had been roasted and ground (1500 g, representing 66.58% m / m of the nutraceutical). The addition was carried out under manual stirring to ensure uniform mixing and minimize the loss of entrained air. The mixing of the microemulsion with the remaining ingredients was carried out manually by applying a coating motion to form a macroemulsion with all the ingredients of the final formulation of the nutraceutical.

[0231] Subsequently, the emulsion mixture was cooled together with the seed and oil mass that constituted the nutraceutical, and the nutraceutical was obtained through all its ingredients. It was initially cooled at room temperature and then at a temperature of 8 °C for 5 to 24 hours. Once the mass was cooled, it was cut and portioned.

[0232] The final composition of the variant V2 emulsion contains 6 components with different properties (water, air, Plukenetia volubilis oil, stevia extract, egg white, and turmeric extract).

[0233] In both variants, more than one component performs various biological or functional functions, such as Plukenetia volubilis oil, turmeric extract, soy lecithin, and egg white, as described for each component above.

[0234] The obtained nutraceutical was in the form of a stick, cut into individual pieces with a mass of 40 g, covered with waterproof paper, and stored at a temperature of 10 °C.

[0235] In the V2 variant, the nutraceutical contains three different sources of fatty acids, phytosterols, and triglycerides, such as pumpkin seeds, Sacha Inchi oil, and egg white. The final nutraceutical of Variant 2 (V2) contains three components with antioxidant activity: pumpkin seeds, turmeric extract as part of the emulsion, and stevia extract also as part of the emulsion.

[0236] The final composition of the nutraceutical includes a source of hypoglycemic compounds, particularly pumpkin seeds. In this V2 variant, different sources of antihypercholesterolemic compounds are used, particularly Sacha Inchi oil and egg white. To prepare the nutraceutical, a source of anti-inflammatory compounds is used, including stevia extract (which is part of the emulsion) and pumpkin seeds. In the composition of the V2 variant, a protein source of plant origin is used, such as pumpkin seeds.

[0237] The V2 variant of the composition contains components that provide vitamins, macroelements, and microelements in amounts sufficient to supplement their different deficiencies or maintain the necessary physiological levels, particularly pumpkin seeds, which provide vitamins A, K, E, and folic acid; soy lecithin provides choline, and the ethanolic extract of turmeric provides sodium, potassium, magnesium, calcium, and iron.

[0238] The nutraceutical composition contains substances that provide sensory properties, such as being easy to chew and swallow without adhering to the upper digestive tract of the subjects and patients consuming it, particularly Sacha Inchi oil, which in addition to masking the taste of the turmeric extract, gives the nutraceutical a pleasant consistency, increases adhesiveness, makes the nutraceutical easy to swallow, and facilitates chewing. On the other hand, the stevia extract used in V2 provides sweetness to the composition, eliminating or reducing the characteristic flavor of the turmeric extract.

[0239] The final formulation contains Sacha Inchi oil with fatty acids containing 6 to 12 carbons.

[0240] The nutraceutical composition obtained according to the results of V2 and Example 1 can be used for the prevention or treatment of diseases, disorders, or syndromes, including: cognitive deficiencies, such as Alzheimer's disease; mental, behavioral, and developmental disorders, including depression and neurological disorders; all of which are related to the presence of medium-chain fatty acids and omega fatty acids, components with antioxidant, anti-inflammatory, and hypoglycemic activity, and zinc, calcium, and vitamins (particularly A, B, and C). Due to the presence of vitamins, proteins, antibacterial, antifungal, and anthelmintic compounds, and suitable lipids, it can also be effectively used to treat digestive system diseases.

[0241] Due to the presence of zinc in certain amino acids, especially tryptophan, as well as anti-inflammatory substances and other bioactive elements in its composition, this nutritional supplement is suitable for treating diseases and disorders of the immune and endocrine systems. Due to the ability of this nutritional supplement's composition and the product itself to reduce triglycerides and cholesterol, in addition to the above factors, it is also suitable for circulatory system, cardiovascular and cerebrovascular diseases.

[0242] Since the composition of this nutritional supplement contains antibacterial, antifungal and anthelmintic compounds, and its stability has been confirmed, it can be used to treat diseases caused by bacterial, fungal and parasitic infections. Due to the amino acid composition, trace elements and macroelements, vitamins and antioxidants, as well as other components of this nutritional supplement, it is used to treat tumors and blood diseases. Generally speaking, due to its content of fat, carbohydrates, proteins, vitamins and minerals, it is highly recommended for combating fatigue, tiredness and malnutrition.

[0243] It is recommended to consume this nutritional supplement twice a day, 40 g each time, once every two days for one month, take a break for 3 to 30 days, and repeat the application cycle.

[0244] The results of the different sensory evaluations of the nutritional supplements obtained according to variants V1 and V2 are shown below.

[0245] Sensory evaluation of the obtained nutritional supplements.

[0246] Sensory evaluation was carried out with the help of a panel consisting of 8 untrained members, who evaluated sensory characteristics such as odor, flavor, color, consistency, chewiness, elasticity, stiffness, adhesiveness and uniformity according to a hedonic scale (0 to 5). For all trials and all variants, the following ratings were obtained on this scale: "Very pleasant" (5), "Pleasant" (4), "Acceptable but characteristic" (3), "Less acceptable" (2), "Unacceptable" (1) and "Completely unpleasant" (0).

[0247] In addition, the presence of foreign objects, oil separation, the presence of lumps, palatability slipperiness and fiber structure were also evaluated.

[0248] The odor attribute received a score of three (mid-value) corresponding to "Acceptable but characteristic". In this case, it is due to the presence of turmeric extract, and this odor is characteristic of this spice. The flavor and color received the same rating of "Acceptable but characteristic", which is also due to the presence of turmeric, and the aftertaste of V2 is a bit bitter due to the aqueous extract of stevia. Generally speaking, both are "acceptable" and, according to the group, are not unpleasant.

[0249] The consistency rating is 4. There is no deformation in any of the variants. The chewiness (3.25), stiffness (3), and adhesiveness (5), which are parameters characterizing mechanical properties, were rated as "adequate". In the view of the research team, these characteristics are the most difficult to ensure, but are necessary for the elderly. In particular, the easy chewability and easy swallowability as described above.

[0250] The homogeneity obtained an "acceptable" (3) value, which is largely due to the inclusion of most of the ingredients (water, oil, lecithin, sucrose or stevia extract, turmeric extract) in the emulsion form.

[0251] Generally speaking, the selection of nutraceutical ingredients, the methods used to process them, the procedures for obtaining the emulsion, and the formulation of the final product make it possible to obtain two experimental variants, which, considering their composition and sensory characteristics, as characteristics of such nutraceuticals presented in the form of nougat or solid bars, meet all the design requirements for the prevention and treatment of Alzheimer's disease and other conditions.

[0252] The effects of the ingredients and the health product on the antioxidant activity of aged OF1 mice.

[0253] Experimental protocol Male OF1 mice at 64 weeks of age (15 to 16 months) with a body weight range between 45 g and 50 g, treated with the product, were compared with animals of the same age and young animals at 4 to 5 months of age that were not treated with anything. Throughout the experiment, the animals were housed in a conventional room with a controlled environment (minimum safety barrier type IV), at a temperature of 21 ± 3 °C, a relative humidity between 40% and 70%, 18 air changes per hour, 100% injection of external air, and 85% filtration. In addition, the animals had 12 hours of light and 12 hours of automatically controlled darkness, and had free access to water and food. They were grouped at a ratio of 5 animals per polypropylene cage, padded with ground bagasse. In all cases, environmental enrichment was applied to reduce aggression between group members in each cage (cardboard and plastic cones).

[0254] Treatment The aged animals were distributed in 4 groups (G2 to G5), and the young animals were in group G1. In two control groups (the aged group (group G2) and the young group (group G1)), a 10% Tween 20 solution dissolved in 0.9% NaCl was used as the intragastric (i.g.) solvent. Group G3 received an ethanol extract of turmeric as described in the present invention, at a dose of 300 mg / kg by intragastric administration, and was administered intravenously in a volume of 1.1 mL. Groups G4 and G5 received the pumpkin seed ingredients and the nutraceutical of variant 1 (V1) orally, as a supplement to the normal diet, at a dose of 3 g / animal.

[0255] For each group, the treatment was carried out from Monday to Friday for 5 weeks. The response to the treatment was analyzed by TBARS index, such as lipid oxidation damage and total antioxidant capacity in brain homogenate.

[0256] Parameters evaluated Animals were sacrificed by cervical dislocation, and brains were extracted from 5 animals in each group. Subsequently, brain homogenates were prepared in Tris buffer at pH 7.6 containing 0.32 M sucrose, 10 mM Tris, and 1 mM EDTA, and differential centrifugation was performed according to the method described by Uwe and Von Hagen in 2009 (Uwe, M. and J. Von Hagen (2009): Isolation of subcellular organelles and structures. Methods Enz. 463: 305 - 326) until the post - mitochondrial fraction was obtained. The supernatant was aliquoted into 1 mL portions and stored at - 80 °C. The total antioxidant capacity of these homogenates was measured according to the instructions of the TAS kit (RANDOX, UK). In addition, the lipid oxidation damage was quantified using the thiobarbituric acid - reactive substances (TBARS) method according to Okawa et al. in 1979 (Okawa, O., N. Ohishi and K. Yagi (1979): Assay of lipid peroxides in animal tissues by the thiobarbituric acid reaction. Anal Biochem. 95(2): 351 - 58). This method involves spectrophotometric measurement of substances reacting with thiobarbituric acid (TBA), which is based on the stoichiometric reaction of two TBA molecules with one malondialdehyde (MDA) molecule. MDA is one of the products of the chain reaction called lipid peroxidation. The reaction of MDA with TBA forms a pink compound, which has a maximum absorbance (ABS) at a wavelength of 532 nm in acidic solution. TBARS is determined by the molar extinction coefficient of MDA (ξ = 155 mM-1cm-1) and the protein concentration in the tissue homogenate, and the protein concentration in the tissue homogenate is determined according to the modified Lowry method for biological tissues by Upreti et al. in 1988 (Upreti, G.C., R.A. Ratcliff and Riches P.C. (1988): Protein Estimation in Tissues Containing High Levels of Lipid: Modifications to Lowry's Method of Protein Determination. Analytical Biochemestry. 168: 421 - 427).

[0257] Result Table 17 shows that an oral formulation of a nutraceutical administered at a rate of 3 g / animal from Monday to Friday for 5 weeks is able to reduce the oxidative damage that appears in the brains of aged mice; even significantly lower values than those of the young control group were obtained. In group G2, there was a significant increase in lipid damage in the brain compared to group G1. In the case of the group supplemented with turmeric extract and pumpkin seeds, the damage was significantly reduced compared to the old control group, while no differences were found compared to the young control group animals.

[0258] A reduction in lipid peroxidation damage in brain homogenates was found in groups G3 to G5, which can be considered a beneficial effect of the treatment, since the literature describes this damage as a physiological event associated with the aging process and neurodegenerative diseases, reported by Myhre et al. in 2013 (Myhre, O., H. Utkilen, N. Duale, G. Brunborg and T. Hofer (2013): Metal dyshomeostasis and Inflammation in Alzheimer's and Parkinson's diseases: Possible impact of environmental exposure. http: / / dx.doi.org / 10.1155 / 2013 / 726954 ; accessed: 8 - 07 - 2016), so reducing this damage is beneficial. Nevertheless, it should be noted that the groups supplemented with nutraceuticals showed the best results in this regard.

[0259] The determination of the total antioxidant capacity in brain homogenates showed that group G3, which received turmeric extract supplementation, was the only group that did not show a significant difference compared to the young animal group (G1) that received the vehicle ( Figure 3 ). In the case of groups G4 and G5, their antioxidant capacity was significantly higher than that of the old control group. This result confirmed that extracts with a composition similar to that of turmeric extract have antioxidant effects.

[0260] Although group G3 obtained the best results in terms of this variable, the nutraceutical treatment had more effects on the overall antioxidant activity, including the two variables analyzed.

[0261] These results indicate that it is not obvious that the combination of all natural components of natural origin but with different chemical properties overcomes the antioxidant effects of the individual components, as has been described in the existing scientific literature. These substances are combined with other components (such as trace elements, macroelements, and vitamins) in a very unique way to form a solution that has never been described before. Unexpectedly, compared with that found in young animals, a lower oxidative damage to lipids in brain homogenates was demonstrated in the group of old mice treated with this dietary supplement.

[0262] In terms of total antioxidant activity, it is also possible to demonstrate a statistically significant improvement in the activity of the group of mice treated with the dietary supplement compared to untreated old mice. This other effect has not been described previously in animal models of product aging incorporating the components described in the present invention.

[0263] From the above two variants, once the protective and therapeutic effects of the dietary supplement are confirmed, new compositional variants and process parameter changes are designed, which in principle do not significantly change the original design concept of the dietary supplement due to the selection of components with a common composition and biological activity. Thus, egg lecithin can be used instead of soy lecithin as an emulsifier and to form foam because of their similar chemical composition and biological properties.

[0264] Based on the evaluation results of biological activity in animal model experiments, this product can be used for the prevention or treatment of diseases in which oxidative stress plays a relevant role, including: Alzheimer's disease; other mental disorders such as Parkinson's disease; cardiovascular, cerebrovascular, tumor, and blood diseases.

[0265] Table 17. Effects of ethanol extracts of turmeric, pumpkin seeds, and dietary supplement on antioxidant activity

[0266] *Significant difference compared with G1. + Significant difference compared with G2* Example 3 Nutritional variant 3 (V3) Preparation of the emulsion components.

[0267] To prepare the emulsion, an aqueous liquid phase consisting of 250 g of water (equivalent to 26.82% m / m of the dietary supplement) was selected, heated to 100 °C and 218 g of sucrose (sugar) was added as a sweetener (equivalent to 23.39% m / m of the dietary supplement). A "sugar-in-water" syrup was prepared by heating the mixture at a temperature of 80 °C with a sugar:water ratio without stirring until the sugar was completely dissolved and then cooled to 40 °C.

[0268] The egg white was selected as the emulsifier and added in an amount of 32 g (3.43% m / m relative to the total mass of the nutraceutical) and 15.05 mL of turmeric water extract (1.61% m / m relative to the total mass of the nutraceutical).

[0269] The components were stirred and mixed at a stirring speed of 10000 1 / min to obtain an emulsion. 80 g of Plukenetia volubilis oil (8.58% m / m relative to the mass of the nutraceutical) was added to the oil phase. No oil-soluble substances were pre-added to the Plukenetia volubilis oil phase. When these components were stirred, gaseous phase (air) was introduced, which represented 50% of the emulsion volume (31.92% of the total volume of the nutraceutical). At this emulsion preparation stage, the temperature was maintained at 25 °C.

[0270] The final composition of the emulsion of Variant 3 (V3) contains five components of different properties (water, air, oil, sugar, egg white).

[0271] In these two variants, more than one component plays various biological or functional roles, and the roles of each component and their biological activities are described in the description of the present invention. At this stage, the emulsion was maintained at a temperature of 25 °C. In this way, a four-phase emulsion variant was obtained: aqueous phase: oil phase: gaseous phase: solids dissolved in water.

[0272] Meanwhile, as described in the experiment of Example 1, the quality of zucchini seeds was prepared, shelled, ground and roasted. In total, 2000 g of seeds were taken, roasted in a cast iron container, ground in a plastic cup mill, mixed with water and left to decant for 1 hour. The precipitate was separated with a grille, and the seeds were separated from the precipitate with a sieve. The precipitate was separated with a grille and then drained. The seed quality was dried in a convection oven at a temperature of 80 - 90 °C for 6 hours. The substance was ground and sieved through a 1 mm sieve to obtain a roasted, dried and ground seed quality with a protein content of 32%.

[0273] The emulsion was mixed with the seeds to form a macroemulsion of the food paste type: 432 g of the obtained emulsion (equivalent to 46.4% m / m relative to the total mass of the nutraceutical) was added to 500 g of shelled, ground and roasted seeds (53.6% m / m relative to the mass of the nutraceutical). The addition was carried out under manual stirring to ensure uniform mixing and minimize the loss of entrained air. By applying a coating motion, the emulsion and the seeds were manually mixed to form a macroemulsion with all the components of the final formulation of the nutraceutical.

[0274] Subsequently, the obtained nutraceutical macroemulsion of all components for cooling was initially at room temperature and then at a temperature of 4 °C, with an interval of 24 hours. Once the mass cooled, it was cut and portioned. The obtained nutraceuticals were in the form of sticks, covered with impermeable paper and stored at a temperature of 4 °C.

[0275] In variant V3, the nutraceutical contains three different sources of fatty acids, phytosterols and triacylglycerols, including squash seeds, Sacha Inchi oil and egg white. The final nutraceutical according to variant 3 (V3) contains two components with antioxidant activity, which are squash seeds and Sacha Inchi oil. According to V3, the final nutraceutical composition includes a source of hypoglycemic compounds, especially squash seeds. In this variant, a source of anti-cholesterolemic compounds, especially Sacha Inchi oil, was used. A source of anti-inflammatory compounds, especially squash seeds, was used to produce this nutraceutical.

[0276] In the composition of variant V3, different sources of protein are used, including squash seeds of plant origin and egg white of animal origin. The formulation of nutraceutical V3 contains components that provide vitamins, macroelements and microelements in amounts sufficient to supplement their different deficiencies or maintain the necessary physiological levels, especially squash seeds providing vitamins A, K, E and folic acid.

[0277] The nutraceutical composition contains substances that provide the sensory properties required by the subjects and patients. In particular, Sacha Inchi oil provides a nutraceutical with a softer consistency, less rigid to the taste, increasing the inherent adhesiveness of the product but making it more digestible and improving chewability, with less effort when chewing. Egg white entraps a large amount of air (high expansion rate), which makes the consistency of the nutraceutical softer to the taste and results in a reduced intensity of the color. On the other hand, the stevia extract used in V4 provides a taste-appropriate sweetness to the composition.

[0278] The final formulation includes Sacha Inchi oil containing fatty acids with 6 to 12 carbons.

[0279] The sensory evaluation based on a maximum of 5 points by a panel of 14 evaluators familiar with the product produced the following results: "pleasant" odor (4.07); "pleasant" taste, slightly oily (3.78); "adequate" consistency (4.07); "good elasticity" (4.36); "easy chewability", but the granules are firmer (3.36); "creamy" consistency (4); adhesiveness "adequate", not actually sticking to the mouth (4.43); homogeneity: "homogeneous" (4.86).

[0280] Nutraceutical variant 4 (V4) Preparation of the emulsion components To prepare the emulsion, an aqueous liquid phase consisting of stevia extract was selected as the sweetening agent. This aqueous liquid phase contained stevioside dissolved in water (187 g of extract dissolved in 63 g of water, equivalent to 25.33% m / m of the nutraceutical), and 110 g of water was added (equivalent to 11.14% m / m of the nutraceutical).

[0281] As the emulsifier and while foaming, 32 g of egg white (32.42% m / m relative to the mass of the nutraceutical) and 15.05 mL of the aqueous extract of turmeric (1.52% m / m relative to the total mass of the nutraceutical) were added.

[0282] The components were stirred and mixed at a stirring speed of 10000 1 / min to obtain the emulsion. 80 g of Plukenetia volubilis oil (8.10% m / m relative to the mass of the nutraceutical) was added to the oil phase. No oil-soluble substances were pre-added to the oil phase of Plukenetia volubilis.

[0283] When stirring these components, the gas phase (air) was introduced, which represented 50% of the emulsion volume (24.67% of the total volume of the nutraceutical). For this emulsion preparation step, the temperature was maintained at 25 °C.

[0284] The final composition of the emulsion of variant 4 (V4) contained five components of different properties (water, air, oil, sugar, egg white). In this way, a four-phase emulsion variant was obtained: aqueous phase: oil phase: gas phase: solids dissolved in water.

[0285] Meanwhile, a large amount of zucchini seeds were prepared, shelled, ground and roasted. The emulsion was mixed with the seeds to form a macroemulsion-type food paste: 487.05 g of the obtained emulsion (equivalent to 49.34% m / m of the total mass of the nutraceutical) was added to 500 g of the mass of shelled, ground and roasted seeds (50.66% m / m relative to the mass of the nutraceutical). The addition was carried out under manual stirring to ensure uniform mixing and minimal loss of entrapped air. By applying an enveloping motion, the emulsion and the seeds were manually mixed to form a macroemulsion with all the components of the final formulation of the nutraceutical.

[0286] Subsequently, the macroemulsion of the nutraceutical obtained from all the components was cooled, initially at room temperature and then at 4 °C, at intervals of 24 hours. Once the mass was cooled, it was cut and portioned. The obtained nutraceutical was in the form of a bar, covered with waterproof paper, and stored at a temperature of 4 °C.

[0287] In the V4 variant, the nutraceutical contains several different sources of fatty acids, phytosterols, and triglycerides, including squash seeds and Sacha Inchi oil (fatty acids with 6 to 12 carbons, capable of producing ketone bodies) and egg white. In this variant, more than one ingredient performs multiple biological or functional functions, which are described in the section describing the role of each ingredient and its biological activity.

[0288] The final nutraceutical (V4) contains three ingredients with antioxidant activity as part of an emulsion, including squash seeds, Sacha Inchi oil, and stevia extract. The final composition of the nutraceutical includes a source of hypoglycemic compounds, particularly squash seeds. A source of antihypercholesterolemic compounds is used, particularly Sacha Inchi oil. To compose this nutraceutical, two sources of anti-inflammatory compounds are used, which are stevia extract (forming part of the V4 emulsion) and squash seeds. The nutraceutical of the V4 variant contains ingredients that provide vitamins, macroelements, and microelements in amounts sufficient to supplement their different deficiencies or maintain the necessary physiological levels, particularly squash seeds that provide vitamins A, K, E, and folic acid.

[0289] The nutraceutical composition contains substances that provide the typical sensory characteristics of nougat and bar shapes, suitable for the subjects and patients who consume it; specifically, Sacha Inchi oil provides a nutraceutical with a softer consistency, lower stiffness, increased adhesiveness, making it more digestible and improving chewability. Egg white entraps a large amount of air (high expansion rate), which makes the consistency of the nutraceutical softer for the taste and reduces the color intensity. On the other hand, the stevia extract used in V4 provides a taste-appropriate sweetness to the composition.

[0290] The nutraceutical composition obtained according to V4, through the biological properties of its ingredients, can be used to prevent or treat diseases, disorders, or syndromes accompanied by the following: cognitive impairment; Alzheimer's disease; developmental disorders; digestive, endocrine, circulatory, cardiovascular, and cerebrovascular system conditions, for the prevention or treatment of infectious and parasitic diseases, and for the treatment of fatigue, tiredness, and malnutrition.

[0291] According to composition V4, the nutraceutical is recommended to be consumed two to three times a day, 40 g per day, for one month, with a break of 3 to 30 days, and the administration cycle is repeated.

[0292] Effect of the ingredients of the nutraceutical according to the present invention on cognitive improvement in OF1 mice.

[0293] Experimental protocol Male OF1 mice at 7 to 8 months of age, with a body weight ranging between 45 g and 55 g, were used. In addition, young mice at 1 to 2 months of age with a body weight of 20 g to 24 g were used. Throughout the experiment, the animals were housed in a conventional room with a controlled environment (minimum safety level IV barrier), at a temperature of 21 ± 3 °C, a relative humidity between 40% and 70%, 18 air changes per hour, 100% outdoor air injection, and 85% filtration. In addition, the lighting was automatically controlled with 12 hours of light and 12 hours of darkness, and water and food were freely available. The animals were grouped at a ratio of 5 animals per polypropylene box, and the boxes were lined with ground bagasse.

[0294] Treatment The animals were divided into three groups: one group was young animals (1 to 2 months of age), and the remaining groups were animals at 7 to 8 months of age.

[0295] One of the groups of young animals (G1) and the group of animals at 7 - 8 months of age (G2) were administered 10% Tween 80 dissolved in 0.9% NaCl as a vehicle by intravenous injection, while the remaining group of animals at 7 - 8 months of age was supplemented with 10 mL / kg dose of Plukenetia volubilis oil (variant V3) at a volume of 0.5 mL by intravenous injection. The treatment was carried out daily for 30 days. To evaluate the effect on cognitive improvement, on the 29th and 30th days of the study, a Y - maze test with closed arms was conducted.

[0296] Parameters evaluated Y - maze test with closed arms: Three additional arms of equal length (30 cm) were used, which were connected to each other at a 120° angle. Each arm was identified with a different letter (A, B, C).

[0297] One of the three branches of the Y - maze was blocked. The animal was taken out of the cage by grasping its tail with a gloved hand, and the identification number was checked. Then the animal was placed on the palm of the hand and allowed to move from a high platform to the center of the Y - maze. Seven (7) minutes were marked on a digital clock. When the start button was activated, the animal's tail was released to make it free to start exploring the maze. During these 7 minutes, the experimenter remained quietly in the same position. One hour later, the animal was placed back in the maze, but all three arms were open. Then the digital clock was set back to 7 minutes, and during this time, the experimenter used a stopwatch to calculate the total time the animal spent exploring the new arm. The percentage variable of the scanning time of the new arm representing the total test time was measured using the formula " % = exploration time / 240 s * 100".

[0298] As a criterion for validity, if the animal did not show motor activity within the first 4 minutes, the test was considered invalid.

[0299] Results In Figure 5It was observed that in the Y-maze test with closed arms, in groups G1 and G3, the percentage of time spent on the open arms was significantly lower than the percentage of time spent on the closed arms. In group G2, there was no significant difference between the two groups.

[0300] These results first demonstrated the effectiveness of the animal model used, since in young animals (G1), the time spent in the closed arm (A) was significantly longer, while in animals not supplemented with the V3 variant component, there was no significant difference in the time spent in the different arms, that is, the animals showed cognitive impairment.

[0301] On the other hand, in this work, it was demonstrated that the product was evaluated for improving the cognitive function of OF1 male mice by supplementing at a dose of 10 mg / kg for 30 days with a daily frequency, since in this group, the time spent in arm A was significantly longer than the other arms. In addition, this time was also longer than that of the two control groups (G1 and G2) of the experiment. The cognitive improvement that occurred in this group enabled us to affirm that the supplementation of the existing omega-3 and omega-6 fatty acids stimulates the fluidity of the cell membranes of nerve cells, the adhesion of nerve cells, dendrite formation, and the speed of neurotransmission, which generally favors the cellular processes of learning and memory (Hering, H., C. C. Lin and M. Sheng, (2003): Lipid rafts in the maintenance of synapses, dendritic spins, and surface AMPA receiver stability. J Neurosci, 23(8): 62 - 71).

[0302] In this way, it was demonstrated that the product can be used for the prevention and treatment of: cognitive deficiencies; Alzheimer's disease; mental, behavioral, and developmental disorders, including depression; nervous system and cerebrovascular diseases.

[0303] Example 3 Preparation of a nutraceutical composition of variant 5 (V5) Preparation of the emulsion component Prepare a suspension of solids in the oil phase, including adding 8 g of the ethanol extract concentrate of turmeric obtained according to Example 1 (proportion 1.09% m / m relative to the total mass of the nutraceutical), diluted in 90 g of Plukenetia volubilis oil (proportion 12.23% m / m relative to the total mass of the nutraceutical).

[0304] Select an aqueous liquid phase consisting of 19 g of the stevia extract concentrate (2.58% m / m relative to the mass of the nutraceutical) dissolved in 70 g of water (9.51% m / m relative to the total mass of the nutraceutical), and stir until completely dissolved to form an aqueous phase containing soluble solids.

[0305] The egg white was selected as the emulsifier and 32 g of egg white was added (4.35% m / m relative to the total mass of the nutraceutical). The emulsifier was added to the aqueous phase with stirring at 18,000 1 / min, and the oil phase containing suspended solids was added. By stirring these components, the gas phase (air) was introduced, which represented 40% of the emulsion volume (11.93% of the nutraceutical volume). The emulsion was stored at room temperature. In this way, a four-phase emulsion variant was obtained (water, oil, air, and suspended and dissolved solids: aqueous phase: oil phase: gas phase: solids suspended in the oil and dissolved in the water).

[0306] The pumpkin seeds baked at 80 °C and shelled were ground in a blade grinder with a stainless steel cup at a speed of 12,000 1 / min for 5 minutes until a fine paste was obtained. Then the emulsion mixture was mixed with the seeds and oil mass, i.e., a macroemulsion of the food mass type. 500 g of the baked and ground shelled seeds (67.9% m / m relative to the total mass of the nutraceutical) were taken and 219 g of the emulsion (29.76% m / m relative to the total mass of the nutraceutical) were added and mixed at low speed and with slow movement so that the entrapped air did not escape, and 10 g of Plukenetia volubilis oil (1.36% m / m relative to the mass of the nutraceutical) was added.

[0307] 7 g of cocoa powder (0.95% m / m relative to the mass of the nutraceutical) was added to the emulsion mixture and the seeds and oil mass, and mixing was continued until the components were homogeneous. The product was placed in a rectangular mold and refrigerated at 2 °C for 12 hours. Then it was stored at room temperature.

[0308] The final composition of the V5 emulsion contains 4 phases and 6 components with different properties (water, air, oil, stevia extract, egg white, and curcuminol extract). Plukenetia volubilis oil and cocoa powder were also added to the final composition of the product. In this variant, more than one component performs various biological or functional functions, which have been described for each component above, and cocoa powder was added thereto, which acts as an antioxidant and an anti-inflammatory agent, provides flavor and masks the flavor, odor, color, and bitter aftertaste characteristics of the stevia extract. Other beneficial properties of cocoa powder have been described in the description of the role of each nutrient component above.

[0309] In this V5 variant, the nutraceutical contains four different sources of fatty acids, phytosterols, and triglycerides, which are pumpkin seeds, Sacha Inchi oil, cocoa powder, and egg white. The final nutraceutical of the V5 variant contains four components with antioxidant activity, which are pumpkin seeds, turmeric extract, stevia extract, and cocoa. It includes a source of hypoglycemic compounds, particularly pumpkin seeds. In addition, three different sources of antihypercholesterolemic compounds are used, particularly Sacha Inchi oil, egg lecithin, and cocoa. The representative of the anti-inflammatory compounds is stevia extract, pumpkin seeds as part of the emulsion, and cocoa in the final product formulation.

[0310] Protein sources of plant origin are used, such as pumpkin seeds, and components that provide vitamins, macroelements, and microelements in amounts sufficient to supplement their different deficiencies or maintain the necessary physiological levels, particularly the ethanol extracts of pumpkin seeds, cocoa powder, and turmeric, the contributions of which have been described above. To improve swallowing and chewability and obtain better scores in sensory evaluation, Sacha Inchi oil and stevia extract, the effects of which are described in Example 2, and cocoa powder are used, which in addition to providing a pleasant and characteristic flavor also masks the flavor and color of the turmeric extract, making it closer to traditional foods.

[0311] This nutritional composition can be used for the prevention or treatment of diseases, disorders, or syndromes including the following: cognitive deficiencies such as Alzheimer's disease; mental, behavioral, and developmental disorders including depression; and neurological, digestive, immune, endocrine, and circulatory system conditions; cardiovascular, cerebrovascular, infectious, parasitic, neoplastic, and blood diseases; and the treatment of fatigue, tiredness, and malnutrition caused by the reasons already described in the above examples.

[0312] It is recommended to consume once a day, 40 g each time, once a day for one month, rest for 3 to 30 days, and repeat the administration cycle.

[0313] According to the feedback from consumers, the sensory evaluation of the nutraceutical shows that the taste, color, and smell are more "pleasant" than all previous variants. The consistency is smoother and it is easier to swallow. There is no structural separation or breakage.

[0314] Effect of Nutraceutical Ingredients on Cognitive Improvement in Aged OF1 Mice Experimental Protocol When turmeric extract was administered to aged male OF1 mice by gavage at a dose of 300 mg / kg in a volume of 1.1 mL, the effect on cognitive impairment was evaluated. In this experiment, a design similar to Experiment 1 was used, but three treatment groups were formed: two groups (young control group and aged control group) received 10% Tween 20 dissolved in 0.9% NaCl, and Group G3 was supplemented with the V5 variant component. The test was conducted from Monday to Friday for 5 weeks. The response to the treatment was analyzed by the Morris water maze test.

[0315] Parameters evaluated Morris water maze test: It was conducted in a plastic tank with a diameter of 120 cm, and a plastic platform with a square upper base was placed inside the tank. The test consisted of two phases: a training phase lasting four days, during which each animal was subjected to 4 trials per day from the same position; and a retention phase on the 5th day without a platform. During the 4-day training process, the platform remained in a fixed position, and the animals were placed with their backs to the platform, i.e., their faces facing the tank wall. In each training session, the animals were allowed to swim for 90 seconds until they found the platform. The animals were allowed to stay on the platform for 10 to 30 seconds. On the 5th day of the test, the platform was removed from the water tank, and all the animals were placed in the same position and swam in the water tank for 60 seconds. With the help of a video player, the time spent by each animal in each of the 4 quadrants and the time (latency) taken for each animal to first reach the quadrant where the platform was located (Quadrant 1) were calculated.

[0316] Results At the end of the 5-week treatment, the Morris water maze test was applied to evaluate cognitive improvement. In this test, the aged control mice (G2) took longer to find the platform quadrant than the other animals ( Figure 6)。This result demonstrated the cognitive improvement of the supplemented group G3 in terms of the latency during the acquisition phase. These animals spent less time on their first visit to the quadrant, although there was no significant difference compared to the young animals. It has been documented in the literature that in terms of this variable, the performance of old animals is the worst. R. D'Hooge and P. P. De De Deyn in 2001 (R. D'Hooge, P. P. De De Deyn. Applications of the Morris water maze in the study of learning and memory. Brain Research Reviews 36(2001)60 - 90) argued that as animals age, they experience a decline in cognitive function and a decrease in performance efficiency in this behavioral test. All these phenomena are due to changes in the swimming, locomotor, and exploratory abilities of these animals. It is believed that this is consistent with the structural and physiological changes in some brain structures (especially the hippocampus) related to spatial learning.

[0317] It can be seen that the use of turmeric extract in the composition of the nutraceutical resulted in no statistical difference in the cognitive status of old mice compared to untreated young mice (although a shorter latency was noted). This result was purely unexpected because it was hypothesized that the treated old animals would show improvement compared to the untreated old mouse group.

[0318] Similar to the effects of the above nutraceutical, the product formulated with this ingredient can be used for the prevention and treatment of: cognitive deficits; Alzheimer's disease; mental, behavioral, and developmental disorders, including depression; neurological and cerebrovascular disorders.

[0319] Example 4 Effect of Nutraceutical on Cognitive Improvement in Aged Mice Experimental Protocol The nutraceutical of V1 variant according to Example 2 was evaluated as a supplement to the normal diet at a ratio of 3 g / animal in old male OF1 mice. In this experiment, a design was used in which 3 treatment groups were formed, where two groups (young control group and old control group) received 10% Tween 20 dissolved in 0.9% NaCl, and the G3 group was supplemented with the nutraceutical from Monday to Friday for 5 weeks.

[0320] In the last week of treatment, the three groups were subjected to the Y - maze test (spontaneous alternation) and the passive avoidance test.

[0321] Parameters Evaluated Y - maze: Three arms of equal length (30 cm) were added, interconnected at 120° angles. Each arm was identified with a different letter (A, B, C). The test was conducted for 7 minutes. At the start of the test, the animal was placed at the center of the maze. Entry was considered when all four legs were within one of the arms. Alternation was considered when the animal visited three branches of the maze in succession without repeating the entrance to the branch it had entered previously. Additionally, the number of entries into the arms was used as an indicator of locomotor activity. Based on the number of alternations, the variable percentage of alternation was calculated through the following expression: Where: Total possible alternations = Total entries - 2 Passive avoidance: Animals were transferred from their daily living quarters to the experimental area 24 hours in advance to familiarize them with the place. For this test, a box with two compartments, one bright and one dark, was used. The dark compartment had a closed circuit that produced a weak electric shock. This was to teach the rats to avoid the dark compartment where they were shocked.

[0322] The test started with training, which consisted of placing the rats in the illuminated compartment. At 25 seconds, the door to the dark compartment was opened until the rat spontaneously moved towards it.

[0323] When the rat entered the dark compartment with all four paws, the door was closed and it was given an electric shock of 0.3 mA for 5 seconds. Ten seconds after the shock was applied, the rat was returned to its cage.

[0324] The long - term memory ability was evaluated by allowing the mice to return to the illuminated compartment after 24 hours and making the dark compartment freely accessible to them (i.e., the door of the dark compartment was opened).

[0325] The animal was left in the passive - avoidance box for 5 minutes, during which the time (latency) it took for the animal to first enter the dark compartment was measured.

[0326] Results After 5 weeks of treatment with this nutritional health product, the Y - maze test was applied to evaluate the cognitive improvement in animals that had orally received the supplement. Although no significant difference was found in the variable number of entries into the arms of the Y - maze between the two groups ( Figure 7 A), this was not the case for the percentage of alternation. In this sense, the percentage of alternation in the animals of the nutritional health - product supplemented group was significantly higher compared to the old control group ( Figure 7 B).

[0327] Table 18 shows that the nutraceutical administered as a dietary supplement from Monday to Friday successfully improved the cognitive function of mice with defects. The results obtained in the Y-maze test in this experimental procedure significantly demonstrated the superiority of the supplemented group (G3) in terms of percentage of alternation. In addition, it showed behavior similar to that of the young control group (G1) and did not show significant differences. These results indicate that the mice in the supplemented group remembered the last arm entered better than the old control group and oriented themselves better in the compartment. It also indicates that based on the memory mechanism evaluated in the test, it is certain that through treatment, cognitive improvement was obtained and thus a greater treatment effect was achieved.

[0328] As demonstrated, by achieving that the cognitive state of the animals receiving nutraceutical treatment not only exceeded that of the old animals but also did not show significant differences relative to the young animals, this nutraceutical has more excellent technical advantages compared to other previously reported technical solutions.

[0329] Table 18. Effects of oral nutraceutical for 5 weeks at a frequency of 5 times a week

[0330] During the experiment, a passive avoidance test was also conducted on the experimental animals. In the acquisition phase of the test, there was no significant difference in the time for the animals receiving nutraceutical treatment and those receiving placebo treatment to enter the dark compartment ( Figure 8 A). This allows us to be certain that both groups of animals started from the same locomotor conditions and aging did not affect their speed of entering the dark compartment. On the other hand, after receiving electrical stimulation, the cognitive function of the animals in the nutraceutical-supplemented group improved relative to the old control group ( Figure 8 B). The passive avoidance test has traditionally been used as a quick and simple method to explore short-term and long-term memory. In this case, it was used to measure long-term memory, and the presence of cognitive impairment could be confirmed in the old control group animals because they spent less time returning to the dark compartment where they received the aversive stimulus.

[0331] On the other hand, the animals receiving the nutraceutical had a longer latency than the animals in G2 group, and their performance was similar to that of G1 group, indicating that they remembered the received stimulus, which can be regarded as a positive effect of the treatment.

[0332] This may be related to the presence of a nutritional composition sourced from ω-fatty acids in Sacha Inchi oil, which is a component with a high content of polyunsaturated fatty acids such as linoleic acid (18:2) (i.e., ω-6) and linolenic acid (18:3) (i.e., ω-3). These fatty acids are considered essential for all animals. ω-3 fatty acids are crucial for the development and growth of the nervous system. In addition, there is the presence of cocoa, and the health benefits it provides have been widely documented.

[0333] This other example reinforces the claims of the nutraceutical for the prevention and treatment of: cognitive deficiencies; Alzheimer's disease; mental, behavioral, and developmental disorders, including depression; cerebrovascular and nervous system disorders.

[0334] Example 5 Hypoglycemic effect of a nutraceutical and its ingredients coconut oil, Sacha Inchi oil, and turmeric extract on OF1 mice.

[0335] Experimental protocol Treatment Using the same design as in Example 2, but forming 5 groups of animals aged 7 to 8 months and 1 group of young animals. Groups G1 to G2 received the same treatment as described in Example 3, while groups G3 and G4 received the coconut oil and Sacha Inchi oil ingredients at the same dose, frequency, and mode of administration as in Example 3. In addition, group G5 received turmeric extract at the same dose and route of administration as described for that ingredient in Example 3, while group G6 received the nutraceutical orally at a rate of 3 g per animal per day on average. To evaluate the hypoglycemic effect, the serum glucose concentration of the animals bled at the end of the supplementation period was measured. For this purpose, a glucose detection kit (HELFA Diagnósticos, Cuba) was used.

[0336] Results Compared with age-matched animals that did not receive supplementation (G2, placebo), the glucose concentration in groups G3 to G6 was significantly reduced. In addition, a comparison between them showed that there was no significant difference between the group supplemented with the nutraceutical and the groups receiving coconut oil and Plukenetia volubilis oil. At the same time, the glucose level in the case of turmeric extract was significantly higher than that of the group supplemented with the nutraceutical (p < 0.05) Figure 9)。The decrease in glucose levels constitutes a positive effect of the oils, turmeric extract, and nutraceuticals evaluated, as it has been shown that in humans, in populations at risk of Alzheimer's disease, lower cerebral glucose metabolism exists prior to the clinically measurable onset of cognitive impairment. Additionally, in vitro and animal studies have shown that hypometabolism in the brain may precede and contribute to the neuropathological cascade that leads to cognitive impairment in Alzheimer's disease. On the other hand, this hypometabolism of glucose in the brain may be attributed to defects in glucose transport across the blood-brain barrier, glycolysis, and / or mitochondrial function, whereby this physiological condition leads to elevated serum levels of this molecule during the aging process (Cunnane SC, Nugent S, Roy M, Courchesne-Loyer A, Croteau E et al. Brain fuel metabolism, aging and Alzheimer's disease. Nutrition. 2011 27(1):3-20. doi:10.1016 / j.nut.2010.07.021).

[0337] Surprisingly and unexpectedly, administration of the nutraceutical and several of its active ingredients resulted in a decrease in blood glucose levels relative to young and old untreated animals.

[0338] Because of the combination of the above three ingredients, this effect was not obvious. Although no significantly different results were produced between groups 3 to 6, differences were shown between the nutraceutical-treated group and the groups treated with each ingredient alone.

[0339] The results of the animal model experiments indicate that the nutraceutical can be used for the prevention or treatment of certain diseases, disorders, or as nutritional support, particularly diseases related to glucose metabolism disorders, including: cognitive deficits; Alzheimer's disease; mental, behavioral, and developmental disorders, including depression; neurological conditions; cerebrovascular diseases, tiredness, and fatigue.

[0340] Example 6 Cholesterol-lowering and triglyceride-lowering effects of the nutraceutical and coconut oil components on OF1 mice Experimental protocol The same design as in Example 3 was used Treatment The same design as in Example 3 was used, but three groups of animals aged 7 to 8 months were formed. Groups G1 to G3 received the same treatment as described in Example 2, while group G4 received the nutraceutical ingredients at the same dose, frequency, and route of administration as described in the previous example. To evaluate the effect of reducing blood cholesterol and triglycerides, the concentrations of serum triglycerides and cholesterol were measured. The Monotrigli test and Colestest reagent set (HELFA Diagnósticos, Cuba) were used for this purpose.

[0341] Results Analysis of the collected serum samples showed that in groups G3 and G4, triglyceride and cholesterol levels were significantly reduced compared to the elderly control animals receiving placebo (G2). Additionally, the levels of two biochemical parameters related to lipid metabolism did not show significant differences compared to young animals (G1) ( Figure 10 ). These results constitute a beneficial effect of these ingredients, as it is known that increased serum cholesterol and triglyceride levels increase the risk of developing dementia, including Alzheimer's disease (Proitsi P, Lupton MK., Velayudhan L, Newhouse S, Fogh I, Tsolaki M et al. Genetic Predisposition to Increased Blood Cholesterol and Triglyceride Lipid Levels and Risk of Alzheimer Disease: A Mendelian Randomization Analysis. PLOS Medicine, 2014, 11(9):e1001713).

[0342] In the experimental model, it was determined that this nutraceutical, due to its cholesterol-lowering properties and ability to reduce triglyceride content, can prevent or be used in the treatment of: cognitive deficits; Alzheimer's disease; mental, behavioral, and developmental disorders, including depression; disorders of the nervous, digestive, endocrine, and circulatory systems; cardiovascular, cerebrovascular, neoplastic, and blood diseases; tiredness, fatigue, and malnutrition.

[0343] Example 8 Anti-inflammatory effect of a nutraceutical and an ethanolic extract of turmeric on OF1 mice Experimental protocol The same design as in Example 2 was used Treatment Older animals were divided into 3 groups (G2 to G4), and younger animals were divided into G1. The animals were given oral supplements. Two control groups (older animals (G2) and younger animals (G1)) were supplemented with a placebo diet made of soybean oil, wheat flour, eggs, and refined sugar. Groups G3 and G4 received turmeric extract and nutraceuticals, respectively. In all groups, the administration was carried out after the animals were deprived of their normal diet for 4 hours (fasting). The diet was given ad libitum, and the average consumption per animal was measured to be 3 g.

[0344] To evaluate the anti-inflammatory effects of the supplements, a behavioral test for sensitivity to heat-iron pain was used. The mice were placed on a stainless-steel surface maintained at 50 ± 1 °C. The animals were kept on the hot iron until they exhibited one of two behaviors considered to indicate nociception: jumping or shaking / licking the hind paw (Mogil, J.S., Wilson, S.G., Bon, K., Lee, S.E., Chung, K., Raber, P., Pieper, J.O., Hain, H.S., Belknap, J.K., Hubert, L., et al. Heritability of nociception i: Responses of 11 inbred mouse strains on 12 measures of nociception. Pain 1999, 80, 67 - 82). The experimenter recorded the time when the animal exhibited one of the pain behaviors. Mice that did not show any of the expected pain behaviors within the first 60 seconds were excluded.

[0345] Results The results showed that group G4 (supplemented with nutraceuticals) showed a sensitivity to heat pain similar to that of the younger animals (G1). In addition, there was no significant difference between groups G2 and G3, but it was significantly higher than that of groups G1 and G4 ( Figure 11 ). These results suggest that nutraceuticals reduce the inflammation that occurs during the natural aging process and affect nociception (King-Himmelreich, T.S., CV., Wolters, M., Olbrich, K., Geisslinger, G., Niederberger, E. Age-Dependent Changes in the Inflammatory Nociceptive Behavior of Mice. Int. J. Mol. Sci. 2015, 16, 27508 - 27519; doi:10.3390 / ijms161126041).

[0346] The product composition obtained according to the present invention can be used as a nutraceutical for preventing or treating diseases or disorders, the cause or consequence of which is inflammation and which is based on alterations in the immune response and defense of the living organism, such as: Alzheimer's disease; mental, behavioral and developmental disorders, including depression; disorders of the nervous, digestive, endocrine and circulatory systems; cardiovascular, cerebrovascular, oncological and blood diseases; tiredness, fatigue and malnutrition.

[0347] Example 9 Preparation of a new nutraceutical variant (V6) Preparation of the emulsion components Prepare a solid oil phase suspension by adding 5.03 g of the turmeric hydroalcoholic extract obtained according to Example 1 (proportion 0.52% m / m relative to the total mass of the nutraceutical) and dissolving it in 80 g of Plukenetia volubilis oil (proportion 8.28% m / m relative to the total mass of the nutraceutical). For this, the mixture is stirred in a temperature-controlled bath at 50 °C for 4 hours. Centrifuge at a speed of 4300 1 / min.

[0348] Select an aqueous liquid phase consisting of 80 g of water (8.28% m / m relative to the total mass of the nutraceutical) to dissolve 250 g of sugar (25.88% m / m relative to the total mass of the nutraceutical), heat until boiling and reach the syrup point without stirring to form an aqueous phase containing soluble solids, and cool to 40 °C.

[0349] Select soy lecithin as the emulsifier and add 1.6 g (proportion 0.17% m / m relative to the total mass of the nutraceutical). The emulsifier is added to the aqueous phase by stirring with an ultra-high speed stirrer, and the Plukenetia volubilis oil phase already containing the turmeric extract is added. The emulsion is stored at room temperature.

[0350] On the other hand, take 32 g of egg white as a foaming agent and stir until a foam is formed, but at the same time add the emulsifier (3.31% m / m relative to the mass of the nutraceutical) and add it to the emulsion. When these components are stirred, the gas phase (air) is introduced, representing 40% of the emulsion volume (18.58% of the nutraceutical volume).

[0351] In this way, a four-phase emulsion variant is obtained (aqueous phase, oil phase, air and suspended and dissolved solids): aqueous phase: oil phase: gas phase: solids dissolved in the oil phase and solids dissolved in the water.

[0352] Pumpkin seeds that have been baked and shelled at 80 °C are ground in a blade grinder with a stainless-steel cup at a speed of 12,000 1 / min for 5 minutes until a fine paste is obtained. Then the emulsion is mixed with the seed and oil mass (i.e., a macroemulsion of the food substance type). Take 500 g of the mass of shelled, baked, and ground seeds (51.78% m / m relative to the total mass of the nutraceutical), add 448.63 g of the emulsion (46.46% m / m relative to the total mass of the nutraceutical) and mix at low speed with slow movement so that the entrapped air does not escape, and add 10 g of Plukenetia volubilis oil (1.03% m / m relative to the mass of the nutraceutical) to form an emulsion mixture with the seed and oil mass.

[0353] Add 7 g of cocoa powder (0.73% m / m relative to the nutraceutical) to the emulsion mixture and the seed and oil mass, and continue mixing until the components are homogeneous. Place the product in a rectangular mold and refrigerate it at a temperature of 2 °C for 12 hours. Subsequently, store it at room temperature.

[0354] In this variant, it was demonstrated that an emulsion of the four-phase type was obtained: aqueous phase: oil phase: solids dissolved in the oil and solids dissolved in the water. The chemical composition is shown in Table 19.

[0355] Table 19. Chemical composition of the nutraceutical variant V6 Total solids, % Protein, % Total fat, % Ash, % Chloride, % 89.01 35 38.86 3.2 0.45

[0356] The high content of total solids, in which fat predominates, ensures the high stability and preservation of the product, since the product is stored at 8 °C for 1 year without losing its main properties such as flavor, color, and odor, although an increase in stiffness during cutting was observed.

[0357] In this variant 6 (V6), more than one ingredient performs multiple biological or functional functions, which have been described above for each ingredient, and cocoa powder is added to it, which serves as an antioxidant and anti-inflammatory agent, provides flavor and masks the flavor, odor, and color of the turmeric extract, as well as the bitter aftertaste characteristics of the stevia extract. Other beneficial properties of cocoa powder have been described in the above description of the role of each nutrient.

[0358] In this V6 variant, the nutraceutical contains four different sources of fatty acids, phytosterols, and triglycerides, namely pumpkin seeds, Sacha Inchi oil, cocoa, egg white, and soy lecithin. The final nutraceutical of variant V6 contains 3 ingredients with antioxidant activity, which are extracts of pumpkin seeds, turmeric, and cocoa. It includes a source of hypoglycemic compounds, especially pumpkin seeds. In addition, four different sources of antihypercholesterolemic compounds are used, especially Sacha Inchi oil, lecithin in egg white, soy lecithin, and cocoa. The anti-inflammatory compounds in the final formulation of the product are represented by the seeds of pumpkin and cocoa.

[0359] Plant-derived protein sources such as pumpkin seeds are used, and it contains ingredients that provide vitamins, macronutrients, and micronutrients in amounts sufficient to supplement their different deficiencies or maintain the necessary physiological levels, especially the ethanol extracts of pumpkin seeds, cocoa powder, and turmeric, whose contributions have been described above.

[0360] Example 10 Prepare a new variant of the nutraceutical.

[0361] Prepare the emulsion components according to variants 7 (V7), 8 (V8), and 9 (V9) To prepare the base emulsion, an aqueous liquid phase consisting of 250 g of water is selected, heated to 100 °C, 780 g of sucrose (sugar) is added as a sweetener, stirred until completely dissolved, and the temperature is brought to 40 °C.

[0362] The emulsifier soy lecithin (5 g) is selected. The components are stirred and mixed at a stirring speed of 15000 1 / min to obtain a microemulsion. When stirring these components, the gas phase (air) is introduced. At this preparation stage, the emulsion is maintained at a temperature of 25 °C.

[0363] Subsequently, an emulsion oil phase is prepared, which has soluble solids. In this case, the soluble solids are the ethanol extract of turmeric. The oil phase consists of 250 g of Sacha Inchi oil and 15.05 g of the ethanol extract of turmeric. At this preparation stage, the emulsion is maintained at a temperature of 25 °C. In this way, a four-phase emulsion variant (aqueous phase, oil phase, air, and suspended or dissolved solids) is obtained, especially aqueous phase: oil phase: gas phase: solids suspended in the oil phase.

[0364] Meanwhile, prepare the pumpkin seed mass. The seeds are shelled, ground, and roasted. The seeds are dried at a temperature of 80 °C for 60 minutes. The seeds are roasted at a temperature of 130 °C. The seeds are ground in a blade mill to obtain particle sizes between 10 μm and 30 μm. 1500 g of seeds are taken and mixed with the emulsion by manual stirring so as not to lose the air contained. Different mixtures of the emulsion with the seed and oil mass and other ingredients are prepared according to variant V7, V8, or V9.

[0365] For V7, take a mixture of 75 g of emulsion and seeds. Thus, in the mass of 75 g of emulsion and seeds, the specific content of each component can be calculated, and the relationship of these components to the total mass of the V7 dietary supplement is indicated in parentheses.

[0366] Water - 6.70 g (7.88% m / m relative to the total mass of the dietary supplement).

[0367] Sucrose - 20.89 g (24.58% m / m relative to the total mass of the dietary supplement).

[0368] Soybean lecithin - 0.13 g (0.15% m / m relative to the total mass of the dietary supplement).

[0369] Plukenetia volubilis oil - 6.70 g (7.88% m / m relative to the total mass of the dietary supplement).

[0370] Ethanol extract of turmeric - 0.40 g (0.47% m / m relative to the total mass of the dietary supplement).

[0371] Pumpkin seeds - 40.19 g (47.28% m / m relative to the total mass of the dietary supplement).

[0372] Add 10 g of Plukenetia volubilis oil (11.76% m / m relative to the mass of the dietary supplement) to this 75 g.

[0373] Continue mixing until the components are homogeneous. Place the product in a rectangular mold and refrigerate at 2 °C for 12 hours. Then store at room temperature.

[0374] For V8, take a mixture of 65 g of emulsion and seeds. Thus, in the mass of this emulsion and seeds, the specific content of each component can be calculated, and the relationship of these components to the total mass of the V8 dietary supplement is indicated in parentheses.

[0375] Water - 5.80 g (7.88% m / m relative to the total mass of the dietary supplement).

[0376] Sucrose - 18.10 g (24.59% m / m relative to the total mass of the dietary supplement).

[0377] Soybean lecithin - 0.12 g (0.16% m / m relative to the total mass of the dietary supplement).

[0378] Plukenetia volubilis oil - 6.70 g (9.10% m / m relative to the total mass of the dietary supplement).

[0379] Ethanol extract of turmeric - 0.35 g (0.48% m / m relative to the total mass of the nutritional supplement).

[0380] Pumpkin seeds - 34.82 g (47.31% m / m relative to the total mass of the nutritional supplement).

[0381] Add 8.6 g of Plukenetia volubilis oil (11.68% m / m relative to the mass of the nutritional supplement).

[0382] For Variant 9 (V9), take 41 g of an emulsion mixture with seed mass (macroemulsion) and add 6.47 g of coconut oil (13.63% of the macroemulsion substance).

[0383] In the mass of this emulsion and seeds, the specific content of each component can be calculated, and the relationship of these components relative to the total mass of the nutritional supplement of Variant V9 is indicated in parentheses.

[0384] Water - 3.66 g (7.71% m / m relative to the total mass of the nutritional supplement).

[0385] Sucrose - 11.42 g (24.06% m / m relative to the total mass of the nutritional supplement).

[0386] Soybean lecithin - 0.07 g (0.15% m / m relative to the total mass of the nutritional supplement).

[0387] Plukenetia volubilis oil - 3.66 g (7.71% m / m relative to the total mass of the nutritional supplement).

[0388] Ethanol extract of turmeric - 0.22 g (0.46% m / m relative to the total mass of the nutritional supplement).

[0389] Pumpkin seeds - 21.97 g (46.28% m / m relative to the total mass of the nutritional supplement).

[0390] The chemical composition is shown in Table 20.

[0391] Table 20. Chemical composition of nutritional supplement Variant V9 Total solids, % Total fat, % Carbohydrate, % pH 95.06 46.53 19.55 6.48

[0392] Sensory evaluation of the nutritional supplement Sensory evaluation was carried out with the help of a panel of 11 members familiar with the product, and the sensory characteristics were evaluated according to a hedonic scale (0 to 5): The odor attribute obtained a value of 2.9, corresponding to "acceptable but not very remarkable". The taste is "acceptable but characteristic" (2.2), and the color is also "acceptable" (2.9); the consistency is "pleasant" and "the components do not separate" (3.9). "Easy to chew" (chewability, 3); "sufficient stiffness" and "retains its shape" (adhesiveness, 4.6) and uniformity (3.8). For all panelists, the product is "acceptable" and "pleasant".

[0393] The most significant differences between V8 and V9 are the attributes of uniformity and adhesiveness, and these two attributes are slightly improved.

[0394] This indicates that adding a certain amount of coconut oil to the emulsion mixture with the seed quality of nutraceuticals not only does not damage the sensory quality of the product, but can instead enhance the sensory characteristics of the final nutraceutical, and can provide a large amount of medium-chain fatty acids with neuroprotective functions.

[0395] Variants V7 and V8 contain 3 different sources of fatty acids, phytosterols and triacylglycerols, including pumpkin seeds, Sacha Inchi oil and soy lecithin, while V9 contains 4 because of the addition of coconut oil. The final nutraceuticals of variants V7, V8 and V9 contain 3 components with antioxidant activity, including pumpkin seeds, turmeric extract as part of the emulsion, and soy lecithin as part of the emulsion. In the final composition of the nutraceuticals according to variants V7, V8 and V9, there is 1 source of hypoglycemic compounds, especially pumpkin seeds.

[0396] In these variants V7, V8 and V9, different sources of antihypercholesterolemic compounds are used, especially Sacha Inchi oil and soy lecithin. To form the nutraceuticals according to variants V7, V8 and V9, sources of anti-inflammatory compounds are used, including those contained in pumpkin seeds. In all three composition variants (V7, V8 and V9), protein sources of plant origin are used, such as pumpkin seeds.

[0397] The nutraceutical formula implemented according to variants V7, V8 and V9 contains components that provide vitamins, macroelements and microelements in amounts sufficient to supplement their different deficiencies or maintain the necessary physiological levels, especially pumpkin seeds (providing vitamins A, K, E and folic acid), soy lecithin (providing choline), ethanol extract of turmeric (providing sodium, potassium, magnesium, calcium, iron). The nutraceutical compositions (V7, V8 and V9) of this example contain substances that provide the sensory characteristics required by the consumers, especially Sacha Inchi oil, which in addition to masking the taste of the turmeric extract, also gives the nutraceutical a softer consistency in taste, increases adhesiveness, makes the nutraceutical easier to swallow and facilitates chewing. On the other hand, the sucrose used provides sweetness to the composition, which eliminates or reduces the bitter taste characteristic of the turmeric extract.

[0398] The final formulations of these three variants contain Sacha Inchi oil (which contains fatty acids with 6 to 12 carbons), and obtain ketone bodies from Sacha Inchi oil. The ketone bodies provide energy for neurons when Alzheimer's disease patients face insulin resistance. According to the nutritional supplement compositions obtained from variants V7, V8, and V9 and the results of Example 1, the nutritional supplement can be used to prevent or treat diseases, disorders, or syndromes including the following: cognitive deficiencies such as Alzheimer's disease; mental, behavioral, and developmental disorders including depression; and neurological disorders. These effects are related to the following factors: the presence of medium-chain fatty acids and omega fatty acids; components with antioxidant, anti-inflammatory, and hypoglycemic activities; the presence of zinc, calcium, and vitamins (especially A, B, and C).

[0399] Similarly, due to vitamins, proteins, antibacterial, antifungal, anthelmintic compounds, and suitable lipids, the nutritional supplement is used for digestive system disorders. Due to the zinc content in certain amino acids, especially tryptophan, and the anti-inflammatory substances and other bioactive elements in its components, it is used to treat diseases and disorders of the immune and endocrine systems. Due to its ability to lower triglycerides and cholesterol in its components and the product itself, in addition to the above factors, it is also used for circulatory system diseases, cardiovascular and cerebrovascular diseases. Due to its antibacterial, antifungal, and anthelmintic compounds in its components and its proven stability, it can also be used for bacterial, fungal, and parasitic infectious diseases.

[0400] The amino acid composition, its micro and macro elements, vitamins, antioxidants, and other components make the nutritional supplement composition usable for treating tumors and blood diseases. In addition, generally speaking, due to the content of the nutritional supplement composition in terms of fat, carbohydrates, proteins, vitamins, and minerals, it is strongly recommended for treating tiredness, fatigue, and malnutrition.

[0401] Example 11 Nutritional supplement composition according to the new variants V10 and V11 Variant 10 (V10) To prepare the emulsion, an aqueous liquid phase composed of stevia extract (containing stevioside dissolved in water) (2 g of extract, corresponding to 1.99% m / m of the nutritional supplement) was selected as the sweetener, and 18 g of water (corresponding to 17.92% m / m of the nutritional supplement) was added. 0.4 g of soy lecithin was added as an emulsifier and foaming agent (0.4% m / m relative to the mass of the nutritional supplement).

[0402] The components were stirred and mixed at a stirring speed of 4000 1 / min to obtain droplets of the aqueous phase and the oil phase in the nanometer size, but the solid phase particles of turmeric extract larger than 200 nm remained suspended.

[0403] When these ingredients are stirred, the gas phase (air) is introduced at 30% v / v of the emulsion volume, which represents 12% of the total volume of the nutraceutical. At this preparation stage, the emulsion is maintained at a temperature of 25 °C.

[0404] Subsequently, an emulsion oil phase containing soluble solids is prepared, where in this case the soluble solids are an ethanol extract of turmeric. The oil phase consists of 18 g of Plukenetia volubilis oil (17.93% m / m relative to the mass of the nutraceutical) and 2 g of an ethanol extract of turmeric (1.99% m / m relative to the mass of the nutraceutical). At this preparation stage, the emulsion is maintained at a temperature of 25 °C.

[0405] In this way, a four-phase emulsion variant is obtained (aqueous phase, oil phase, air, and suspended or dissolved solids), specifically: aqueous phase: oil phase: gas phase: solids dissolved in the aqueous phase and solids suspended in the oil phase.

[0406] Meanwhile, the mass of zucchini seeds is prepared. The seeds are shelled, ground, and roasted. The seeds are dried at a temperature of 80 °C for 60 minutes. The roasting of the seeds is carried out at a temperature of 130 °C. The seeds are ground in a blade mill to obtain particles with a size between 10 μm and 30 μm.

[0407] The emulsion is mixed with the mass of seeds to form a macroemulsion of the food paste type. 40.4 g of the emulsion (40.24% m / m relative to the total mass of the nutraceutical) is added to the mass of shelled, roasted, and ground seeds (54 g, equivalent to 53.79% m / m relative to the mass of the nutraceutical). The mixing of the microemulsion with the mass of seeds is carried out manually by applying an enveloping motion to form a macroemulsion with these ingredients of the formulation. 6 g of cocoa powder (5.98% m / m relative to the mass of the nutraceutical) is added to the mixture of seeds and emulsion. An enveloping motion is applied, and the mixing of all the ingredients of the final formulation of the nutraceutical is carried out manually.

[0408] Subsequently, the emulsion mixture is cooled together with the mass of seeds and oil that make up the nutraceutical, and the nutraceutical is obtained through all its ingredients. It is initially cooled at room temperature and then at a temperature of 8 °C for 5 to 24 hours. Once the mass has cooled, it is cut and portioned.

[0409] Variant 11 (V11) Select the aqueous liquid phase and add 2 g of stevia extract (which contains stevioside dissolved in water) as a sweetener (equivalent to 1.99% m / m of the nutraceutical mass) and add 18 g of water (equivalent to 17.92% m / m of the nutraceutical). As an emulsifier and at the same time as a foaming agent, add 0.4 g of commercially available soapwort root extract (0.4% m / m relative to the mass of the nutraceutical). Stir and mix the components at a speed of 4000 1 / min.

[0410] When stirring these components, the gas phase (air) is introduced at 30% v / v of the emulsion volume, which represents 12.12% relative to the total volume of the nutraceutical. For this preparation step, the emulsion is maintained at a temperature of 25 °C.

[0411] Subsequently, prepare the oil phase of the emulsion containing soluble solids, in this case, the soluble solid is the ethanol extract of turmeric. The oil phase consists of 18 g of Plukenetia volubilis oil (17.93% m / m relative to the mass of the nutraceutical) and 2 g of the ethanol extract of turmeric (1.99% m / m relative to the mass of the nutraceutical). At this preparation stage, the emulsion is maintained at a temperature of 25 °C.

[0412] In this way, a four-phase emulsion variant (aqueous phase, oil phase, air, and suspended or dissolved solids) is obtained, specifically: aqueous phase: oil phase: gas phase: solids dissolved in the aqueous phase and solids suspended in the oil phase.

[0413] At the same time, prepare the mass of zucchini seeds. The seeds are shelled, ground, and roasted. The seeds are dried at a temperature of 80 °C for 60 minutes. The seeds are roasted at a temperature of 130 °C. The seeds are ground in a blade mill to obtain particles with a size between 10 μm and 30 μm. The emulsified mixture is formed from the seed mass to form a macroemulsion-type food paste. Add 40.4 g of the emulsion (40.23% m / m relative to the total mass of the nutraceutical) to the shelled, roasted, and ground seed mass (54 g, equivalent to 53.79% m / m of the nutraceutical mass).

[0414] Apply a coating motion, manually mix the microemulsion with the seed mass to form a macroemulsion with these components in the formulation. Add 6 g of cocoa powder (in a proportion of 5.98% m / m relative to the mass of the nutraceutical) to the mixture of seeds and emulsion. By applying a coating motion, manually mix all the components of the final formulation of the nutraceutical.

[0415] Subsequently, cool the emulsion mixture together with the seed and oil mass that make up the nutraceutical to obtain the nutraceutical through all its components, initially cooling at room temperature and then at a temperature of 8 °C for 5 to 24 hours. Once the mass has cooled, cut and portion it.

[0416] The final composition of the emulsion of Variant V10 contains 7 components with different properties (water, air, Sacha Inchi oil, stevia extract, soy lecithin, turmeric extract, and cocoa powder). V11 also contains 7 components, but it differs from V10 in that saponaria extract is used as an emulsifier.

[0417] In these two variants, more than one component performs various biological or functional functions, such as Sacha Inchi oil, turmeric extract, soy lecithin, and egg white, as described for each component above.

[0418] In Variant V10, the nutraceutical contains four different sources of fatty acids, phytosterols, and triacylglycerols, namely pumpkin seeds, Sacha Inchi oil, soy lecithin, and cocoa powder, while V11 contains three sources because it does not contain lecithin.

[0419] The final nutraceuticals of Variants 10 and 11 (V10 and V11) contain three components with antioxidant activity, which are pumpkin seeds, turmeric extract as part of the emulsion, and stevia extract as part of the emulsion. The final compositions of the two nutraceutical variants include a source of hypoglycemic compounds, especially pumpkin seeds, and at the same time use a source of antihypercholesterolemic compounds, especially Sacha Inchi oil.

[0420] To compose this nutraceutical, sources of anti-inflammatory compounds are used, including stevia extract (forming part of the emulsion) and pumpkin seeds. In both Compositions V10 and V11, protein sources of plant origin are used, such as pumpkin seeds. Both variants show compositions containing components that provide vitamins, macroelements, and microelements in amounts sufficient to supplement their different deficiencies or maintain the necessary physiological levels, especially pumpkin seeds that provide vitamins A, K, E, and folic acid, soy lecithin that provides choline, and turmeric extract that provides sodium, potassium, magnesium, calcium, and iron.

[0421] The nutraceutical composition obtained according to these two variants contains substances that provide sensory characteristics (such as odor, color, taste, chewiness, and swallowability), and during the sensory evaluation process, it has a value higher than 3 on a scale of 0 - 5 and can be considered to meet the needs of the subjects and patients who consume it. Specifically, in addition to masking the taste of turmeric extract, Sacha Inchi oil also gives the nutraceutical a smoother consistency, increases adhesiveness, makes the nutraceutical easier to swallow, and promotes chewiness. On the other hand, the stevia extract used in V2 provides sweetness to the composition, which eliminates or reduces the characteristic flavor of turmeric extract.

[0422] The final formulation includes Sacha Inchi oil containing fatty acids with 6 to 12 carbons.

[0423] As in the previous examples, the nutraceutical compositions obtained according to variants V10 and V11 can also be used for the prevention or treatment of diseases, disorders or syndromes, including: cognitive deficiencies such as Alzheimer's disease; mental, behavioral and developmental disorders, including depression; and neurological conditions. All these uses are related to the following factors: the presence of medium-chain fatty acids and omega fatty acids; components with antioxidant, anti-inflammatory and hypoglycemic activities; the presence of zinc, calcium and vitamins (especially A, B and C). Similarly, due to the presence of vitamins, proteins, antibacterial, antifungal and anthelmintic compounds as well as suitable lipids, the nutraceutical can be used for the treatment of digestive system diseases, and due to the zinc content in certain amino acids (especially tryptophan), as well as anti-inflammatory substances in its components, and other bioactive elements, it can be used for the treatment of diseases and disorders of the immune and endocrine systems.

[0424] Due to the ability of its components and the product itself to reduce triglycerides and cholesterol, in addition to the above factors, it is also suitable for circulatory system diseases, cardiovascular and cerebrovascular diseases. Due to the antibacterial, antifungal and anthelmintic compounds in its components and the stability exhibited, it can also be used for bacterial, fungal and parasitic infections.

[0425] The amino acid composition, its trace and macro elements, vitamins and antioxidants, and other components are suitable for the treatment of tumors and blood diseases. Generally, its content in fats, carbohydrates, proteins, vitamins and minerals is highly recommended for fatigue, tiredness and malnutrition. Sensory evaluation showed an obvious turmeric flavor and a slightly bitter aftertaste characteristic of stevia, which can be accepted by subjects accustomed to consuming turmeric-based products.

[0426] The chemical composition is shown in Table 21.

[0427] Table 21. Chemical composition of nutraceutical variant V10 Total solids, % Protein, % Total fat, % Ash, % Chloride, % 89.19 10.63 47.81 4.6 0.14

[0428] Example 12 Variant 12 (V12) To prepare the emulsion, an aqueous liquid phase consisting of 27 g of sucrose as a sweetener (equivalent to 15.49% m / m of the nutraceutical mass) was selected and 13 g of water (7.46% m / m of the nutraceutical) was added. It was heated to dissolve and cooled to 40 °C.

[0429] 0.3 g of soy lecithin (0.17% m / m relative to the mass of the nutraceutical) was added as an emulsifier and at the same time as a foaming agent.

[0430] Stir and mix the components at a stirring speed of 200001 / min to obtain droplets of an aqueous phase with an oil phase in millimeter size, but solid particles of turmeric extract larger than 200 nm (which are not dissolved but suspended in the oil phase) remain suspended.

[0431] By stirring these components, the gas phase (air) is introduced at 30% v / v of the volume of the emulsion and reaches 16.3% of the total volume of the nutraceutical. At this preparation stage, the emulsion is maintained at a temperature of 25 °C. Subsequently, the oil phase of the emulsion containing soluble solids is prepared. In this case, the soluble solid is the ethanol extract of turmeric. The oil phase includes 13 g of Plukenetia volubilis oil (7.46% m / m relative to the mass of the nutraceutical) and 1 g of the ethanol extract of turmeric (0.58% m / m relative to the mass of the nutraceutical). At this preparation stage, the emulsion is maintained at a temperature of 25 °C.

[0432] In this way, a four-phase emulsion variant (aqueous phase, oil phase, air, and suspended or dissolved solids) is obtained, specifically: aqueous phase: oil phase: gas phase: solids dissolved in the aqueous phase and solids suspended in the oil phase.

[0433] Meanwhile, prepare the mass of whole zucchini seeds with shells, roast and grind them to take 54 g and add them to the emulsion, and mix them with 54 g of shelled pumpkin seeds (61.96% of the mass of the emulsion relative to the mass of the nutraceutical).

[0434] Mix the emulsion with the seed mass to form a food paste-like macroemulsion. Add 54.3 g of the emulsion (31.15% m / m relative to the total mass of the nutraceutical) to the mass of shelled, roasted, and ground seeds. By applying a coating motion, manually mix the microemulsion with the seed mass to form a macroemulsion with these components of the formulation. Add 12 g of cocoa powder to the mixture of seeds and emulsion (6.88% m / m relative to the mass of the nutraceutical). By applying a coating motion, manually mix all the components of the final formulation of the nutraceutical.

[0435] Subsequently, cool the emulsion mixture together with the seed and oil mass that make up the nutraceutical, and obtain the nutraceutical through all its components. First, cool it at room temperature, and then cool it at a temperature of 8 °C for 5 to 24 hours. Once the mass is cooled, cut and portion it.

[0436] The chemical composition is shown in Table 22.

[0437] Table 22. Chemical composition of nutraceutical variant V12 Total solids, % Protein, % Total fat, % Ash, % Chloride, % 89.19 18.75 40.47 4.0 0.12

[0438] Sensory evaluation of the nutraceutical Sensory evaluation was carried out with the help of a panel of 7 members familiar with the product, and the results are as follows: The odor attribute obtained a value of 2.71, corresponding to "acceptable, but not very prominent". The taste was "acceptable, but with characteristics", although it was a bit bitter (3.9); the color was also "acceptable" (3); the consistency was "pleasant" and the components did not separate (3.9). "Easy to chew" (chewability, 3); the stiffness was "sufficient" and it maintained its shape (4.43); the adhesiveness was "sufficient" (4.14) and the uniformity was (3.71). The product was "acceptable" and pleasant to all panel members.

[0439] This example demonstrates that whole and shelled processed seeds can be combined, and there are different ratios between the components of the initial emulsion and the nutraceutical macroemulsion.

[0440] Example 13 Preparation of a nutraceutical with a new variant 13 (V13) To prepare the emulsion, an aqueous liquid phase consisting of sucrose (57 g, 26.6% m / m of the nutraceutical mass) as a sweetening agent was selected, and 18 g of water (8.4% m / m of the nutraceutical) was added. It was dissolved by heating and cooled to 40 °C.

[0441] 0.3 g of soy lecithin (0.14% m / m relative to the mass of the nutraceutical) was added as an emulsifier and also as a foaming agent.

[0442] These components were stirred and mixed at a stirring speed of 20000 1 / min to obtain droplets of the charged phase and the oil phase in millimeter size, but the solid phase particles of turmeric extract larger than 200 nm (which were not dissolved but suspended in the oil phase) remained suspended.

[0443] By stirring these components, the gas phase (air) was introduced at 30% v / v of the emulsion volume and reached 13.2% relative to the total volume of the nutraceutical. At this preparation stage, the emulsion was maintained at a temperature of 25 °C.

[0444] Subsequently, the oil phase of the emulsion containing soluble solids was prepared, which was the ethanol extract of turmeric in this case. The oil phase consisted of 18 g of Plukenetia volubilis oil (8.4% m / m relative to the mass of the nutraceutical) and 1 g of the ethanol extract of turmeric (0.47% m / m relative to the mass of the nutraceutical). At this preparation stage, the emulsion was maintained at a temperature of 25 °C.

[0445] Meanwhile, seeds of whole zucchinis were prepared, soaked in water at 60 °C for 30 minutes, drained for 2 hours, and dried in an oven at 80 °C. They were ground, placed in a metal container, and baked at a temperature above 90 °C. 108 g of whole seeds with husks were obtained (50.4% m / m relative to the mass of the nutraceutical), dried, ground, and baked for introduction into the emulsion. The emulsion was mixed with the mass of the seeds to form a macroemulsion of the food paste type. 94.3 g of emulsion were added to the mass of the shelled, baked, and ground seeds (44% m / m relative to the total mass of the nutraceutical).

[0446] The mixing of the microemulsion with the mass of the seeds was carried out manually by applying an enveloping motion to form a macroemulsion with these components of the formulation. 12 g of cocoa powder were added to the mixture of seeds and emulsion (5.6% m / m relative to the mass of the nutraceutical). The enveloping motion was applied to manually mix all the components of the final formulation of the nutraceutical.

[0447] Subsequently, the emulsion mixture was cooled together with the mass of the seeds and oil that make up the nutraceutical, and the nutraceutical was obtained through all its components, initially cooled at room temperature and subsequently at a temperature of 8 °C for a period of 5 to 24 hours. Once the mass was cooled, it was cut and portioned.

[0448] The chemical composition is shown in Table 23.

[0449] Table 23. Chemical composition of the nutraceutical variant V13 Total solids, % Protein, % Total fat, % Carbohydrate, % Ash, % Chloride, % 88.61 10.63 27.22 20.68 3.7 0.18

[0450] Sensory evaluation of the nutraceutical The product was evaluated by a panel of 7 members familiar with the product, and the results were as follows: the odor attribute obtained a value of 3.42, corresponding to "sufficient". The taste was "acceptable and characteristic" (3.3), the color was likewise "acceptable" (2.85); the consistency was "pleasant, and the components did not separate" (3). The product was "easy to chew" (chewability 3.14); the stiffness was "sufficient and maintained its shape" (3.85); the stickiness (3.42) and uniformity (3.57). The product was "acceptable" and pleasant to all panel members.

[0451] Example 14 Variant 14 (V14) was prepared.

[0452] To prepare the emulsion, an aqueous liquid phase consisting of Apis mellifera honey (40 g, 21.34% m / m of the nutraceutical) as a sweetening agent was selected to form the emulsion (the ratio of the oil phase with suspended solids to the aqueous phase with soluble solids) and 18 g of water (9.61% m / m of the nutraceutical) was added. 0.4 g of soy lecithin (0.21% m / m relative to the mass of the nutraceutical) was added as an emulsifier and also as a foaming agent.

[0453] The components were mixed with stirring at a speed of 200001 / min. While stirring these components, the gas phase (air) was introduced at 30% v / v of the emulsion volume, which reached 12.4% relative to the total volume of the nutraceutical. At this preparation stage, the emulsion was maintained at a temperature of 25 °C.

[0454] Subsequently, the oil phase of the emulsion containing soluble solids was prepared. In this case, the soluble solid was an ethanol extract of turmeric. The oil phase consisted of 18 g of Plukenetia volubilis oil (9.61% m / m relative to the mass of the nutraceutical) and 1 g of an ethanol extract of turmeric (0.53% m / m relative to the mass of the nutraceutical). At this preparation stage, the emulsion was maintained at a temperature of 25 °C.

[0455] Meanwhile, the mass of defatted, ground, roasted, and reground zucchini seeds was prepared. 104 g of seeds were used for introduction into the emulsion (55.5% m / m relative to the nutraceutical) and mixed with the emulsion. 77.4 g of emulsion (39.7% m / m relative to the total mass of the nutraceutical) was added to the defatted, roasted, and ground seed mass. The mixing of the microemulsion with the seed mass was carried out manually by applying a coating motion to form a macroemulsion with these components of the formulation. 6 g of cocoa powder (3.2% m / m relative to the nutraceutical) was added to the mixture of seeds and emulsion. The coating motion was applied and the mixing of all the components of the final formulation of the nutraceutical was carried out manually.

[0456] Subsequently, the emulsion mixture was cooled together with the seed and oil mass that constituted the nutraceutical, and the nutraceutical was obtained from all its components. It was initially cooled at room temperature and then at a temperature of 8 °C for 5 to 24 hours. Once the mass was cooled, it was cut and portioned. The addition of honey provided a pleasant taste to the nutraceutical and helped reduce the characteristic flavor of the turmeric extract. The combination with cocoa powder improved the sensory properties of the product and was easily acceptable to the tasters.

[0457] The chemical composition is shown in Table 24.

[0458] Table 24. Chemical composition of the nutraceutical variant V14 Total solids, % Protein, % Total fat, % Carbohydrate, % Ash, % Chloride, % 92.72 16.88 35.20 12.20 4.8 0.18

[0459] Example 15 Prepare Variant 15 (V15).

[0460] To prepare the emulsion, an aqueous liquid phase consisting of Apis mellifera honey (40 g, 21.82% m / m of the nutraceutical quality) as a sweetening agent was selected to form the emulsion (the ratio of the oil phase with suspended solids to the water phase with soluble solids) and 18 g of water (10.72% m / m of the nutraceutical) was added.

[0461] 0.4 g of soy lecithin (0.24% m / m relative to the mass of the nutraceutical) was added as an emulsifier and at the same time as a foaming agent.

[0462] The components were mixed with stirring at a speed of 200001 / min. While stirring these components, the gas phase (air) was introduced at 30% v / v of the emulsion volume, which reached 13.92% relative to the total volume of the nutraceutical. At this preparation stage, the emulsion was maintained at a temperature of 25 °C. Subsequently, the oil phase of the emulsion containing soluble solids was prepared, and in this case, the soluble solid was the ethanol extract of turmeric. The oil phase consisted of 18 g of Plukenetia volubilis oil (10.72% m / m relative to the mass of the nutraceutical) and 1.5 g of the ethanol extract of turmeric (0.89% m / m relative to the mass of the nutraceutical). At this preparation stage, the emulsion was maintained at a temperature of 25 °C.

[0463] Meanwhile, a large mass of dehulled, roasted, and ground zucchini seeds was prepared. 84 g of seeds were used to introduce into the emulsion (50.03% m / m relative to the nutraceutical) and mixed with the emulsion. 77.9 g of the emulsion (46.40% m / m relative to the total mass of the nutraceutical) was added to the mass of dehulled, roasted, and ground seeds.

[0464] The mixing of the microemulsion with the seed mass was carried out manually by applying a coating motion to form a macroemulsion with these components of the formulation. 6 g of cocoa powder (3.57% m / m relative to the mass of the nutraceutical) was added to the mixture of seeds and emulsion. The coating motion was applied to manually mix all the components of the final formulation of the nutraceutical.

[0465] Subsequently, the emulsion mixture was cooled together with the seed and oil mass constituting the nutraceutical, and the nutraceutical was obtained through all its components. It was initially cooled at room temperature and then at a temperature of 8 °C for 5 to 24 hours. Once the mass was cooled, it was cut and portioned.

[0466] The chemical composition is shown in Table 25.

[0467] Table 25. Chemical composition of the nutraceutical Variant V15 Total solids, % Protein, % Total fat, % Carbohydrate, % Ash, % Chloride, % 92.94 13.75 40.32 20.68 3.7 0.17

[0468] Example 16 Prepare Variant 16 (V16).

[0469] To prepare the emulsion, an integrated aqueous liquid phase consisting of fructooligosaccharides was selected as the sweetener (50 g, 23.54% m / m of the nutraceutical mass) to form an emulsion (the ratio of the oil phase with suspended solids to the water phase with soluble solids) and 18 g of water (8.47% m / m of the nutraceutical) was added.

[0470] 0.4 g of soy lecithin (0.19% m / m relative to the mass of the nutraceutical) was added as an emulsifier and at the same time as a foaming agent.

[0471] The components were stirred and mixed at a stirring speed of 20,000 rpm. While stirring these components, the gas phase (air) was introduced at 30% v / v of the emulsion volume, which reached 12.35% relative to the total volume of the nutraceutical. At this preparation stage, the emulsion was maintained at a temperature of 25°C. Subsequently, the oil phase of the emulsion containing soluble solids was prepared, and in this case, the soluble solids were the ethanol extract of turmeric. The oil phase consisted of 18 g of Plukenetia volubilis oil (8.47% m / m relative to the mass of the nutraceutical) and 1.0 g of the ethanol extract of turmeric (0.47% m / m relative to the mass of the nutraceutical). At this preparation stage, the emulsion was maintained at a temperature of 25°C.

[0472] Meanwhile, the mass of dehulled, roasted, and ground zucchini seeds was prepared. 104 g of seeds were used for introduction into the emulsion (48.96% m / m relative to the nutraceutical) and mixed with the emulsion. 87.4 g of the emulsion (41.15% m / m relative to the total mass of the nutraceutical) was added to the mass of dehulled, roasted, and ground seeds. The mixing of the microemulsion with the seed mass was carried out manually by applying a coating motion to form a macroemulsion with these components of the formulation. 6 g of cocoa powder (2.82% m / m relative to the mass of the nutraceutical), 4 g of Plukenetia volubilis oil (1.88% m / m relative to the mass of the nutraceutical), and 11 g of dehulled, roasted, and ground almond fruits (5.18% relative to the total mass of the nutraceutical) were added to the mixture of seeds and emulsion. The mixing of all the components of the final nutraceutical formulation was carried out manually using a coating motion.

[0473] Subsequently, the emulsion mixture was cooled together with the seed and oil mass constituting the nutraceutical, and the nutraceutical was obtained through all its components. It was initially cooled at room temperature and then at a temperature of 8°C for 5 to 24 hours. Once the mass was cooled, it was cut and portioned.

[0474] The chemical composition is shown in Table 26.

[0475] Table 26. Chemical composition of the nutraceutical variant V16 Total solids, % Protein, % Total fat, % Carbohydrate, % Ash, % Chloride, % 91.80 19.38 35.16 18.87 3.85 0.18

[0476] Due to the addition of almonds, the taste of this variant is pleasant to the senses and no separation is observed; on the contrary, the fruit mass combines very well with the nutraceutical.

[0477] In addition to being used as a flavor and odor improving ingredient, almond fruits also provide monounsaturated fatty acids, calcium, vitamin E, and vitamin C, and are a source of antioxidants (in addition to those already included in other embodiments).

[0478] Example 17 Prepare variant 17 (V17).

[0479] To prepare the emulsion, an aqueous liquid phase consisting of Apis mellifera honey (40 g, corresponding to 20.30% m / m of the nutraceutical mass) as a sweetening agent was selected to form the emulsion (the ratio of the oil phase with suspended solids to the water phase with soluble solids) and 18 g of water (corresponding to 9.13% m / m of the nutraceutical) was added.

[0480] 0.4 g of soy lecithin was added as an emulsifier and foaming agent (0.2% m / m relative to the mass of the nutraceutical). These ingredients were stirred and mixed at a stirring speed of 200001 / min. While stirring these ingredients, the gas phase (air) was introduced at 30% v / v of the emulsion volume, which represents 11.73% relative to the total volume of the nutraceutical. At this preparation stage, the emulsion was maintained at a temperature of 25°C.

[0481] Subsequently, the emulsion oil phase containing soluble solids was prepared. In this case, the soluble solids were the ethanol extract of turmeric. The oil phase consisted of 18 g of Plukenetia volubilis oil (9.13% m / m relative to the mass of the nutraceutical) and 1.0 g of the ethanol extract of turmeric (0.51% m / m relative to the mass of the nutraceutical). At this preparation stage, the emulsion was maintained at a temperature of 25°C.

[0482] Meanwhile, the mass of dehulled, roasted, and ground zucchini seeds was prepared. 104 g of seeds were used to introduce into the emulsion (52.78% m / m relative to the nutraceutical) and mixed with the emulsion. 77.04 g of the emulsion (39.10% m / m relative to the total mass of the nutraceutical) was added to the mass of dehulled seeds that had been roasted and ground.

[0483] By applying a coating motion, the mixing of the microemulsion and the seed mass was carried out manually to form a macroemulsion with these components of the formulation. 6 g of cocoa powder (3.05% m / m relative to the nutraceutical mass), 4 g of Sacha Inchi oil (2.03% m / m relative to the nutraceutical mass), and 6 g of Moringa oleifera leaf powder (3.05% of the total nutraceutical mass) were added to the mixture of the seed and the emulsion.

[0484] Using a coating motion, the mixing of all the components of the final nutraceutical formulation was carried out manually. Subsequently, the emulsion mixture was cooled together with the seed and oil mass that make up the nutraceutical, and the nutraceutical was obtained through all its components, initially cooled at room temperature and then at a temperature of 8 °C for 5 to 24 hours. Once the mass was cooled, it was cut and portioned.

[0485] Example 18 Variant 18 (V18) was prepared from variant V17 and is highly similar to it.

[0486] Italian honeybee honey was selected as the sweetener (40 g), and 18 g of water was added. 0.4 g of Agave americana leaf extract was added as an emulsifier and also as a foaming agent. The components in which air was trapped and held in the composition were stirred and mixed as in V17. The oil phase of the emulsion consisted of 18 g of Sacha Inchi oil and 1.0 g of the ethanol extract of turmeric. Dehulled, roasted, and ground zucchini seeds (104 g) were prepared and mixed with the emulsion (77.04 g). 6 g of cocoa powder and 4 g of Sacha Inchi were added. The process continued as in variant V17 until the final product was obtained.

[0487] Example 19 Variant 19 (V19) was prepared from variant V17 and is highly similar to it.

[0488] Italian honeybee honey was selected as the sweetener (40 g), and 18 g of water was added. 0.4 g of soy lecithin was added as an emulsifier and also as a foaming agent. The components were stirred and mixed as in V17. The oil phase of the emulsion consisted of 18 g of Sacha Inchi oil, 0.8 g of the ethanol extract of turmeric, and 0.2 g of pepper extract. In addition, it contained air as part of the emulsion. Dehulled, roasted, and ground zucchini seeds (104 g) were prepared and mixed with the emulsion (77.04 g). 6 g of cocoa powder and 4 g of Sacha Inchi were added. The process continued as in variant V17 until the final product was obtained.

[0489] Example 20 Variant 2 (V2) was prepared from variant V17 and is highly similar to it.

[0490] Select Italian honeybee honey as a sweetener (40 g), and add 18 g of water. Add 0.4 g of soy lecithin as an emulsifier. Stir and mix the ingredients as done in V17. The oil phase of the emulsion consists of 18 g of Plukenetia volubilis oil and 1.0 g of ethanol extract of turmeric. The emulsion contains air trapped during the processing. Prepare shelled, roasted, and ground zucchini seeds (104 g) and mix them with the emulsion (77.04 g). Continue the process according to variant V17; add 6 g of cocoa powder, 4 g of Plukenetia volubilis, and 6 g of cocoa fruit mass. Continue the process as in variant V17 until the final product is obtained.

[0491] Example 21 Variant 21 (V21) is prepared from variant V17 and is highly similar to it.

[0492] Select the juice of Agave tequilana as a sweetener (40 g), and add 18 g of water. Add 0.4 g of soy lecithin as an emulsifier. Stir and mix the ingredients as done in V17. The oil phase of the emulsion consists of 18 g of Plukenetia volubilis oil and 1.0 g of ethanol extract of turmeric. The emulsion contains air trapped during the processing. Prepare shelled, roasted, and ground zucchini seeds (104 g) and mix them with the emulsion (77.04 g). Continue the process according to variant V17; add 6 g of cocoa powder and 4 g of Plukenetia volubilis. Continue the process as in variant V17 until the final product is obtained.

[0493] Example 22 Variant 22 (V22) is prepared from variant V17 and is highly similar to it.

[0494] Select Italian honeybee honey as a sweetener (40 g), and add 18 g of water. Add 0.3 g of soy lecithin and 0.1 g of pectin as emulsifiers. Stir and mix the ingredients as done in V17. The oil phase of the emulsion consists of 18 g of Plukenetia volubilis oil and 1.0 g of ethanol extract of turmeric. The emulsion contains air trapped during the processing. The substance is prepared from shelled, roasted, and ground zucchini seeds (104 g) and mixed with the emulsion (77.04 g). Continue the process according to variant V17; add 6 g of cocoa powder and 4 g of Plukenetia volubilis. Continue the process as in variant V17 until the final product is obtained.

[0495] Example 23 Variant 23 (V23) is prepared from variant V17 and is highly similar to it.

[0496] Select Italian honeybee honey as the sweetener (40 g), and add 18 g of water. Add 0.4 g of soy lecithin as the emulsifier. Stir and mix the components, and proceed as in V17. The oil phase of the emulsion consists of 18 g of Sacha inchi oil, 0.9 g of ethanol extract of turmeric, and 0.1 g of cocoa extract. The emulsion contains air trapped during the processing. Prepare shelled, roasted, and ground zucchini seeds (104 g) and mix them with the emulsion (77.04 g). Continue the process according to variant V17; add 6 g of cocoa powder and 4 g of Sacha inchi. The process continues as in variant V17 until the final product is obtained.

[0497] Example 24 Variant 24 (V24) is prepared from variant V17 and is highly similar to it.

[0498] Select Italian honeybee honey as the sweetener (40 g), and add 18 g of water. Add 0.4 g of agave leaf extract as the emulsifier. Stir and mix the components, and proceed as in V17. The oil phase of the emulsion consists of 18 g of Sacha inchi oil, 0.9 g of ethanol extract of turmeric, and 0.1 g of cocoa bean extract. The emulsion contains air trapped during the processing. Prepare shelled, roasted, and ground zucchini seeds (104 g) and mix them with the emulsion (77.04 g). Continue the process according to variant V17; add 6 g of cocoa powder and 4 g of Sacha inchi. The process continues as in variant V17 until the final product is obtained.

[0499] Example 25 Variant 25 (V25) is prepared from variant V17 and is highly similar to it.

[0500] Select Italian honeybee honey as the sweetener (40 g), and add 18 g of water. Add 0.4 g of soy lecithin as the emulsifier. Stir and mix the components, and proceed as in V17. The oil phase of the emulsion consists of 18 g of Sacha inchi oil, 0.9 g of ethanol extract of turmeric, and 0.1 g of cocoa extract. The emulsion contains air trapped during the processing. Prepare shelled, roasted, and ground zucchini seeds (104 g) and mix them with the emulsion (77.04 g). Continue the process according to variant V17; add 6 g of cocoa powder, 4 g of Sacha inchi oil, and 6 g of whey protein to the mixture of seeds and emulsion. The process continues as in variant V17 until the final product is obtained.

[0501] Other obvious advantages of the present invention are described as follows: - Nano-sized (5 - 200 nm) and millimeter-sized (over 200 nm) emulsions obtained according to the present invention can cause the components contained therein to lose their color intensity and opacity, presenting a pleasant and attractive color, and this color change can be detected during the sensory evaluation of different variants. Emulsions with a particle size less than 100 nm are lighter in color and more transparent. In addition, the interfacial area is significantly increased, which in turn solubilizes bioactive substances that are soluble at the interface, thereby improving the bioavailability of all components; - These obtained emulsions are independent of the lipolysis of the bioactive components of the composition for digestion and absorption in the intestine, which leads to faster release of the active components; - Compared with previous technical solutions, curcuminoids contained in the product can pass through the blood-brain barrier in a larger quantity because they are accompanied by lipid combinations, microbial protection and anthelmintic substances, as well as anti-inflammatory compounds, which ensures their sufficient absorption at the intestinal level; - A novel and beneficial effect obtained is that the amount of natural emulsifier used to obtain nanoemulsions or microemulsions is much less than the amount of surfactants and cosurfactants described previously, because it is reported that one of the disadvantages of microemulsions is that they require a relatively large amount of these substances relative to the volume of oil; - The emulsifying ability of the emulsion reaches 100%, and the 100% stability exceeds 24 hours. Due to the ability to capture gas phase, the swelling rate is 119% - 150%, which ensures a smooth structure. In the prior art, we have not found such a swelling rate percentage in nutraceuticals; - The advantage of using components derived from plants containing saponin components (these components can ensure a large amount of air is entrapped in the emulsion together with oils, especially soy lecithin) is that they eliminate the hemolytic effect caused by high doses of saponins commonly used in emulsions, while high doses of saponins can cause hemolysis of red blood cells; - Using coconut oil to obtain the final mixture of emulsion and seed and oil quality (food emulsion) ensures the presence of long-chain triglycerides, because they provide great stability for food-type emulsions, avoiding droplet aggregation and size increase due to the Ostwald phenomenon. In the present invention, this phenomenon does not follow the trend described in the previous technical solutions, which is characterized by preventing the obtaining of translucent or transparent nanoemulsions and microemulsions. On the other hand, medium-chain triglycerides present in Plukenetia volubilis oil and coconut oil ensure high solubility of curcuminoids and other bio-compounds of organic nature; - Different from other nutritional health products, the present invention contains almost all the components involved in the processes attributed to the origin of Alzheimer's disease and other neurological diseases (anti-inflammatory, hypoglycemic, cholesterol-lowering, antioxidant, alternative sources that counter insulin resistance at the neuronal level, antibacterial, antifungal, anthelmintic, anti-β-amyloid peptide aggregation, anti-neurofibrillary tangle formation, and neuron synapse promoter), as well as anti-hypertensive, antiviral, anti-toxic, anti-platelet aggregation, cardiovascular protectant, and intestinal microbiota stabilizer, and the content of minerals such as zinc; - The main components are provided by several different substances. For example: fatty acids, from 3 to 5 different sources with different properties, including medium-chain and long-chain; antioxidants, from 3 to 8 different sources with different chemical properties; anti-inflammatory agents, from 1 to 4 different chemical structures; from 1 to 3 sources of hypoglycemic compounds; from 1 to 4 sources of anti-cholesterol compounds. Therefore, they adopt different metabolic pathways to achieve their effects. If the subject shows some difficulties or accompanying diseases that prevent the action of the compounds, the other two pathways can be used for their assimilation and action; - This nutritional health product also contains a series of essential nutrients that support the body, such as: proteins with high nutritional value; essential amino acids; important vitamins for neuronal function, such as vitamins E and B; macro and micro elements such as zinc, calcium, iron, magnesium, manganese, phosphorus, and potassium. This makes it an independent food. This nutritional health product especially contains a large amount of zinc and magnesium, and it is known that zinc and magnesium play a decisive role in cognitive processes; - For nutritional balance, all the elements required by the body, including proteins, fats, carbohydrates, vitamins, trace elements, and macro elements, etc., can be ingested multiple times a day for a long time; - This product contains a large amount of tryptophan, which is an amino acid that can produce serotonin and melatonin in the body, thereby reducing anxiety and insomnia in patients with neurological disorders (especially Alzheimer's disease patients); - All components are of natural origin, especially of plant origin, and in most variants do not contain components of animal origin, except for egg white in some variants, or if there is a need under extremely reasonable circumstances, whey protein is added. This makes them suitable for vegetarians or people who eat a vegan or halal diet. When necessary, animal egg white is added in an appropriate proportion to meet special requirements without compromising the quality of the product; - The present invention is a new type of nutritional health product. Few products in this form are classified within the scope of nutritional health products; it has a food presentation form (nutritional health products are usually tablets, other types of tablets, liquids, capsules), thus eliminating the feeling of taking medicine and stimulating the neuropsychological state, making people feel that they are not taking medicine to treat any disease. This nutritional health product can also be considered a functional food; - The present invention is most suitable for the elderly, especially those with eating coordination disorders, because it does not require chewing or minimal effort and is easy to swallow; - The number of sources of active substances contained in this product exceeds that of ordinary nutritional health products such as capsules and tablets, because several grams to 80 grams can be consumed per intake, or more than 200g per day; - The administration of active ingredients can be adjusted according to the purpose (prevention, supporting patients) and according to the stage of the disease (mild, moderate, severe), by the amount of product per unit intake or daily intake; - This product can have a variety of flavors to suit different tastes; - This product is stable at room temperature and can be refrigerated for several months; - The production technology exists in many countries, ranging from manual to highly mechanized and automated factories; - The raw materials are easily available on the world market and in all cases come from natural sources; - The technical process does not involve substances that are toxic or harmful to organisms in any case and does not produce waste that pollutes the environment; - The selected seeds containing the composition specified in the present invention and processed by the method described herein ensure a high fat absorption capacity (up to 50%) and prevent further separation during the processing and preservation of nutritional health products; - Similarly, due to the presence of hydrophilic proteins and carbohydrates, the seeds selected for nutritional health products with the composition specified in the present invention and processed by the method described herein ensure a high water absorption capacity (up to 50%) and water retention, which helps to maintain the mechanical and sensory properties of the nutritional health products during the process of processing and preservation without reduction, even at high temperatures; - The preparation of the oil-in-water emulsion enhances the effects described in the previous two paragraphs, because the emulsion (especially microemulsion and nanoemulsion) prevents the separation of the oil and water phases; - No other product has so many (at least 7) components with such different properties (seeds, oils, powders, emulsions, fat-soluble and water-soluble substances, emulsifiers, natural flavors), showing the uniformity, integrity and stability of the structure of the present invention; - The drying and baking parameters of the seeds result in "pleasant" odors and flavors, which originate from the protein changes caused by the action of the melanoidin deposition process. In addition, the internal gel of the seeds is retained, and fine grinding helps to avoid significant phase separation processes and oil loss; - Different from other nutritional health products, the preventive, supportive or therapeutic applications of this product cover: cognitive deficiencies; Alzheimer's disease; mental, behavioral and developmental disorders; depressive disorders; as well as neurological, digestive, immune, endocrine, circulatory and cardiovascular system disorders; cerebrovascular, infectious, parasitic, tumor and blood diseases; fatigue and malnutrition; - Using ground or roasted and ground pumpkin seeds, walnuts, hazelnuts or other fruits can prevent these small pieces from being inhaled into the respiratory tract or causing phenomena such as swallowing disorders and choking in the elderly with cognitive deficiencies or swallowing problems; - This product does not pose any danger to children and other subjects because these people may consume the product due to negligence or ignorance; on the contrary, these formulations are completely harmless to humans; - The fine processing process of the nutritional health product ensures the retention of nutritional components, especially vitamins and proteins; - The processing technology is simple and very flexible, and does not require complex or special equipment. This product can be prepared at home, in a small workshop and in industry; - It is possible to prove (not previously achieved) that the oxidative lipid damage in the brain homogenates of the group of old mice treated with the nutritional health product is less than that found in young animals; - It is possible to prove that there is a statistically significant increase in the antioxidant activity of the group of mice treated with the nutritional health product compared to the untreated old mice. This other effect has never been described in the old animal models of the products combined with the components described in the present invention; - This nutritional health product provides technical advantages superior to other previously reported technical solutions because the cognitive state of the animals treated with the nutritional health product not only exceeds that of old animals, but also shows no significant difference compared to young animals; - Compared with the untreated young and old animals, the administration of the nutritional health product and several of its active ingredients results in a decrease in blood glucose levels, which on the one hand exceeds the previous technical solutions in the prior art described by analytical methods.

Claims

1. A solid nutritional health product composition for preventing and treating cognitive impairment, characterized in that it is The following mixture: (i) An emulsion, which is 20% m / m to 60% m / m by mass relative to the total mass of the nutraceutical, and which comprises: a. Plukenetia volubilis oil, which is 5% m / m to 20% m / m b. An aqueous extract, ethanol extract or hydroalcoholic extract of Curcuma longa, which is 0.1% m / m to 10% m / m c. Water or an aqueous solution of one of the following components, which is 3% m / m to 30% m / m i. Piper extract ii. Theobroma cacao extract d. An emulsifier, with a content of 0.1% m / m to 35% m / m, selected from the following: i. Lecithin, especially soy lecithin or egg lecithin, which is 0.1% m / m to 1% m / m ii. An extract of the genus Saponaria, especially an extract of Saponaria officinalis or Saponaria saxatilis, which is 0.1% m / m to 10% m / m iii. Egg white, which is 3% m / m to 35% m / m iv. An extract of the genus Agave, especially an extract of Agave americana, Agave tequilana, Agave fourcroydes, which is 0.1% m / m to 10% m / m e. A selected sweetener, which is 1% m / m to 30% m / m, selected from the following: i. Fructooligosaccharide, which is 1% m / m to 30% m / m ii. Stevia extract, which is 1% m / m to 30% m / m iii. Honey of Apis mellifera ligustica Spinola, which is 15% m / m to 30% m / m iv. Sucrose, which is 10% m / m to 30% m / m v. A wine or extract of the genus Agave, especially an Agave variety, preferably Agave tequilana, which is 10% m / m to 30% m / m; f. Air, which is 0.2% v / v to 50% v / v by volume relative to the volume of the emulsion (ii) Seed and oil mass, which is 40% m / m to 70% m / m by mass relative to the total mass of the nutraceutical, and the components thereof are selected from the following: a. Seeds of the genus Cucurbita, especially seeds of Cucurbita moschata or Cucurbita pepo, which is 40% m / m to 65% m / m b. Plukenetia volubilis oil, which is 1% m / m to 20% m / m.

2. The nutritional health product composition according to claim 1, wherein In the mixture of the emulsion and the seed and oil mass, coconut oil is added, which is 5% m / m to 20% m / m by mass relative to the total mass of the nutraceutical.

3. The nutritional health product composition according to claim 1, characterized in that, In the mixture of the emulsion and the seed and oil mass, cocoa powder is added, which is 0.5% m / m to 9% m / m by mass relative to the total mass of the nutraceutical.

4. The nutritional health product composition according to claim 1, wherein In the mixture of the emulsion and the seed and oil mass, the mass of fruits or other seeds, preferably coconut, is added, which is 1% m / m to 10% m / m by mass relative to the total mass of the nutraceutical.

5. The nutritional health product composition according to claim 1, characterized in that, In the mixture of the emulsion and the seed and oil mass, natural juice or fruit concentrate is added, which is 1% m / m to 5% m / m by mass relative to the total mass of the nutraceutical.

6. The nutritional health product composition according to claim 1, wherein, In the mixture of the emulsion with the seeds and oil mass, a protein source is added, in the form of an isolate, concentrate, extract or whole powder, preferably from Moringa or whey protein, in an amount of 1% m / m to 10% m / m relative to the total mass of the nutraceutical.

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