Instant tea drink for gerodietetic nutrition of people suffering from cardiovascular diseases

Abstract

FIELD: tea industry.SUBSTANCE: soluble tea drink for gerodietetic nutrition of people suffering from cardiovascular diseases, made in the form of a water-soluble powder. The drink includes dry extract of hawthorn fruits in the amount of 12–18 g, dry extract of peppermint leaves in the amount of 4–7 g, dry extract of motherwort herb in the amount of 3–5 g, dry extract of rose hips in the amount of 3–5 g, vitamin C in the amount of 5–8 g, thiamine chloride (vitamin B1) in the amount of 0.1–0.2 g, vitamins A in the amount of 0.05–0.15 g and E in the amount of 1–2 g, isomalt in the amount of 40–50 g, crystalline fructose in the amount of 15-20 g and natural citrus flavoring in the amount of 0.3–0.7. The starting components are indicated in g per 100 g of the finished dry product.EFFECT: invention increases the reliability of prevention and correction of cardiovascular diseases (CVD), improves organoleptic properties (taste, aroma), and ensures ease of use (soluble form, portioned packaging).1 cl, 1 dwg, 5 tbl, 3 ex

Description

[0001] Field of technology to which the invention relates

[0002] The invention relates to the food industry, in particular to the production of specialized food products intended for the prevention and correction of cardiovascular diseases (CVD) in the elderly.

[0003] Technology Level

[0004] Cardiovascular diseases are the most pressing healthcare issue in most countries, including Russia, despite significant progress in the diagnosis and treatment of cardiac pathologies in recent decades. Experts from the World Health Organization (WHO) predict a continued increase in cardiovascular morbidity and mortality in both developed and developing countries, due to lifestyle and dietary factors. CVD is the leading cause of death in Russia, accounting for 57% of all mortality.

[0005] According to the World Health Organization, healthy aging is the process of maintaining functional capacity to ensure well-being in old age, representing a major health and sociodemographic challenge worldwide. Currently, most countries are experiencing a clear demographic shift toward a rapidly increasing proportion of elderly and senile individuals. The concept of population aging is a relatively new issue. Projections indicate that by 2050, the number of older adults aged 60 and over will outnumber adolescents aged 10-24 (2.1 billion versus 2.0 billion).

[0006] Cardiovascular diseases are the leading cause of death and one of the most common. In 2020, approximately 17.5 million people worldwide died from cardiovascular diseases, accounting for 31% of all deaths, including approximately 900,000 in Russia. According to the Minister of Health, cardiovascular diseases account for 44% of mortality in Russia. In 2019, the mortality rate from cardiovascular diseases was 573.2 per 100,000 population. This rate then increased over the next two years, reaching 640.3 in 2021. In 2022, this rate dropped to 566.8 per 100,000 population. Among the causes of cardiovascular mortality, ischemic heart disease ranks first (46% in 2019); other common CVDs include hypertension, heart attacks and strokes, and congenital heart defects.

[0007] Considering that all of the above factors can increase the risk of death or disability and have a negative impact on quality of life, their timely identification and prevention of complications is important.

[0008] According to the WHO, more than three-quarters of all CVD deaths are associated with long-term negative behavioral factors (smoking, unhealthy diet, low physical activity, excessive alcohol consumption), which in turn leads to the development of so-called biological risk factors for CVD. Reducing the prevalence and levels of CVD risk factors through lifestyle changes can slow the progression of these diseases both before and after the onset of clinical symptoms. Although CVD prevention requires attention in patients of all ages, particular attention is given to older patients, as they typically have a number of conditions that can increase the risk of death and reduce quality of life. The primary goal of prevention in this patient group is to maintain optimal health despite chronic diseases.Currently, it is possible to successfully influence the course of a number of diseases using medications to correct risk factors in conjunction with recommendations for developing a healthy lifestyle: quitting smoking, increasing physical activity, and eating a balanced diet.

[0009] A functional food product (Patent RU 2792454, published March 22, 2023) with antioxidant properties is known. It consists of vitamin C, vitamin E, vitamins B2, B6, B9, resveratrol, and taurine, and also contains a combined dry extract of celery roots and leaves, Kuril tea herb, and hawthorn berries. This functional food product was selected as the closest analogue.

[0010] A well-known functional food product has a number of disadvantages:

[0011] - complex production technology: alcohol extraction is used (40% ethyl alcohol), which limits its use in the elderly; requires additional steps (vacuum drying, ball milling); has a high cost due to energy-intensive processes (evaporation, drying);

[0012] - organoleptic properties: the bitter taste of alcohol extracts (celery, Kuril tea), the absence of sweeteners, the pungent smell of ethyl alcohol can cause rejection in the elderly;

[0013] - release form: does not have a clear form (powder / tablets), which complicates the dosage;

[0014] - Ingredients: No sedative components (motherwort, mint), which are critical for cardiovascular disease; taurine and resveratrol have not been proven effective for the 60+ age group; low hawthorn content (less than 0.02% in the finished product) – insufficient for cardioprotection.

[0015] A known product of dietary, preventive and functional nutrition for active longevity (Patent RU 2456824, published 07 / 27 / 2012), consisting of dried grains of wheat, oats, flax seeds, milk thistle and pine nuts, in the form of crushed particles: pomegranate and corn seeds, peas, grape seeds, pumpkin seeds, rose hips, hawthorn, walnut kernels.

[0016] The disadvantages of this product are: it is not specialized for cardiovascular diseases, since the main emphasis is on the general strengthening effect (vitamins, fiber), and not on the cardiovascular system; low concentration of active ingredients (hawthorn - only 2%, rose hips - 2%); technological problems - heat treatment of grains (by steam explosion) destroys vitamins (for example, up to 90% of folic acid) and flavonoids in hawthorn and rose hips, as well as the heterogeneity of the mixture (large particles of grains and nuts require long soaking / cooking); ease of use - it is not a finished product (requires preparation) and there is no portion form (it is difficult to control the dosage for the elderly); organoleptic properties (the bitterness from milk thistle and flaxseed is not masked by sweeteners); Bioavailability - solid particles (seeds, nuts) are poorly absorbed in age-related gastrointestinal disorders, and the lack of vitamin B₁ (thiamine) is critical in heart failure.

[0017] A non-alcoholic beverage with an emulsion structure for enriching the human diet with biologically active substances (variants) is known (Patent RU 2542520, published 02 / 20 / 2015). The drinks include, in a given ratio, variants of herbal compositions of Far Eastern wild plants, citric acid, granulated sugar, vitamin E, an aqueous saponin-containing extract from the red soaproot Saponaria officinalis L. and water. According to the first variant, hawthorn berries, lemon balm leaves, oregano leaves and cranberries are used as the herbal composition. According to the second variant - peppermint (leaves), yarrow (leaves), bearberry (leaves) and rose hips (fruit). According to the third variant - hibiscus (flowers) and echinacea (herb).The invention increases the biological value of the drink, the effectiveness of its targeted preventive and health-improving effects on the human body, and also imparts antioxidant, antibacterial, antiviral and anti-inflammatory properties to the drink.

[0018] However, the well-known soft drink has several potential drawbacks:

[0019] - Limited shelf life: beverages retain acceptable organoleptic and microbiological properties for only 30 days. After this period, their quality deteriorates, which may limit their commercial use;

[0020] - production complexity: the use of aqueous saponin-containing extract from red soap root requires additional preparation stages (filtration, dilution), which complicates the technological process;

[0021] - dependence on specific plant raw materials: the recipes are based on specific wild plants (for example, Saponaria officinalis L.), which may be difficult to access in some regions, which increases the costs of raw materials and logistics;

[0022] - High Sugar Content: All beverage options use significant amounts of sugar, which may be unacceptable to health-conscious consumers;

[0023] - potential allergens: some ingredients (eg echinacea, hibiscus) may cause allergic reactions in certain groups of consumers;

[0024] - the need for pasteurization: the pasteurization process (75–85°C, 10–20 minutes) can negatively affect heat-labile components, reducing their biological activity.

[0025] Disclosure of the essence of the invention

[0026] The technical problem that the invention is aimed at solving is the expansion of the arsenal of specialized products for the prevention and correction of cardiovascular diseases in the elderly, which have a complex effect on the cardiovascular system and contain components of our flora, the natural reserves of which are sufficient for industrial use or their cultivation on a large scale is possible.

[0027] The technical result consists in increasing the effectiveness of the prevention and correction of cardiovascular diseases due to the synergistic action of plant extracts and vitamins; improving the organoleptic properties (taste, aroma) due to the introduction of isomalt, fructose and citrus flavoring; ensuring ease of use (soluble form, portion packaging).

[0028] The claimed technical result is achieved by combining in a soluble tea drink for gerodietetic nutrition of people suffering from cardiovascular diseases, effective doses of dry plant extracts of hawthorn fruits, peppermint leaves, motherwort herb, rose hips and a complex of vitamins with the following content of ingredients, g per 100 g of the finished dry product:

[0029] Dry extract of hawthorn fruits 12–18 Dry extract of peppermint leaves 4–7 Dry extract of motherwort herb 3–5 Dry extract of rose hips 3–5 Vitamin C 5–8 Thiamine chloride (vitamin B₁) 0,1–0,2 Vitamin A 0,05–0,15 Vitamin E 1–2 Isomalt 40–50 Crystalline fructose 15–20 Natural citrus flavoring 0,3–0,7

[0030] These essential components in powder form, which are water-soluble fractions with a targeted therapeutic effect, contain more than 95% of all the medicinal substances of plants, without ballast and harmful substances, in their optimal quantities, have proven their effectiveness in maintaining the health of the cardiovascular system.

[0031] The claimed invention overcomes the shortcomings of similar products through a unique formula and production technology. The proposed tea drink surpasses traditional alternatives in safety, biological value, and its specialized effect on the cardiovascular system. Its natural composition, absence of harmful additives, and proven effectiveness make it an ideal choice for gerodietetic nutrition for people with cardiovascular disease. The drink not only satisfies the need for vitamins and antioxidants but also promotes overall health.

[0032] The claimed tea drink is distinguished by its portioned packaging in 1g tea bags.

[0033] Specialized composition for cardiovascular diseases: motherwort and mint provide a sedative and antispasmodic effect, reducing the load on the cardiovascular system; hawthorn and rose hips strengthen blood vessels and improve coronary circulation; vitamins (A, E, C, B₁) compensate for micronutrient deficiencies in the elderly.

[0034] Improved organoleptic properties: isomalt and fructose mask the bitterness of plant extracts, which is critical for older people with sensitive taste; citrus flavoring increases consumer appeal.

[0035] Ease of use: instant form – ready to drink in 1 minute (similars require boiling or complex preparation); portioned packets ensure precise dosing and ease of use.

[0036] Technological simplicity: dry mixing eliminates heat treatment, preserving the activity of heat-labile components (vitamins); the absence of alcohol extracts makes the product safe for the elderly.

[0037] A systematic review of the results of clinical studies shows that by changing lifestyle and diet, it is possible to significantly reduce mortality from CVD both in patients with coronary heart disease and in the general population: by 35% and 50%, respectively, with smoking cessation; by 25% and 20-30% with sufficient physical activity; by 20% and 15% with moderate alcohol consumption; and by 45% and 15-40% with changes in diet based on two factors.

[0038] The link between a healthy diet and a reduced risk of cardiovascular disease has long been known. Several studies over the years have shown that a healthy diet is effective in the prevention and treatment of most cardiovascular and metabolic diseases. Along with increased physical activity and quitting smoking, a healthy diet is considered the most effective measure for preventing cardiovascular disease.

[0039] The life expectancy of patients with cardiac pathologies caused by atherosclerotic vascular damage (coronary heart disease and hypertension) depends on the correct choice and adherence to dietary therapy. It has been proven that a pathogenetically balanced anti-atherogenic diet has a significant positive effect on the entire symptom complex of coronary heart disease – clinical, metabolic, hemodynamic parameters, the hemostatic system, and the immune system.

[0040] Specialized products known today and used for various diseases have proven their effectiveness in numerous studies. Providing these products with a range of essential nutritional factors, in quantities corresponding to human physiological needs, is a proven method for optimizing the chemical composition of preventive nutrition. This, on the one hand, is aimed at eliminating deficiencies, and on the other, enriching preventive diets with sufficient quantities of effective components (nutrients) helps improve the functioning of organs and systems.

[0041] Minor dietary components, primarily flavonoids, play a significant role in the prevention and treatment of cardiovascular diseases. They act as endogenous antioxidants and have an estrogen-like effect. Plant lignans and isoflavones undergo significant metabolic transformations in the gastrointestinal tract of animals and humans, resulting in the formation of hormone-like compounds that resemble and bind to estrogen receptors in various organs. These compounds can exert effects similar to those of endogenous estrogens.

[0042] Recent research has shown that antioxidants can have a positive impact on human health and lifestyle, helping to prevent and manage several serious diseases. Boosting antioxidant defenses through specialized foods is a reasonable and practical approach to combating chronic diseases such as cancer, cardiovascular disease, neurodegenerative diseases, chronic inflammatory diseases, and diabetes. Antioxidants help prevent the pathophysiology of these diseases, which includes excessive and chronic inflammatory mediators, oxidative stress, and cell death. Antioxidants also help slow the aging process and the development of age-related diseases.

[0043] Currently, herbal components (bioactive ingredients) are widely used for the treatment and prevention of various diseases, which combine high therapeutic activity and relative safety.

[0044] Bioactive ingredients:

[0045] Antioxidants: Antioxidants are molecules that inhibit the oxidation of other molecules. Oxidation is a chemical reaction in which electrons are transferred from a substance to an oxidizing agent, which can lead to the formation of free radicals—toxic byproducts of cellular metabolism that can trigger chain reactions that damage cells. Antioxidants interrupt these chain reactions by scavenging free radical intermediates and inhibiting other oxidation reactions. Antioxidants are often reducing agents, such as thiols, ascorbic acid, or polyphenols. Although oxidation reactions play a key role in life, they can also be harmful. Therefore, plants and animals maintain complex systems consisting of multiple types of antioxidants, such as glutathione, vitamin C, and vitamin E, as well as enzymes such as catalase, superoxide dismutase, and various peroxidases.Low antioxidant levels or inhibition of antioxidant enzymes causes oxidative stress and can damage or kill cells. The human body naturally produces antioxidant molecules, but this process is not always effective, and its effectiveness declines with age. The fundamental nutritional value of fruits and vegetables for disease prevention, especially in light of the current anti-aging wave, has attracted the attention of scientists and consumers to various plants and their components. Many plants have a long tradition in European and North American folk medicine. Thanks to this experience and growing interest, the number of food products containing concentrates or extracts of these plants has increased significantly on the market. These products primarily focus on phenolic compounds, particularly anthocyanins and proanthocyanidins, and their preventive effects.Most supplements are combinations of various plant extracts with vitamins and microelements, etc. Foods rich in antioxidants include berries (blueberries, blackberries, raspberries, strawberries, and cranberries), fruits (apples, avocados, cherries, pears, pineapple, oranges, plums, and kiwi), vegetables (artichokes, spinach, red cabbage, potatoes, and broccoli), beverages (green tea, coffee, red wine, and fruit juices), nuts (walnuts, pistachios, pecans, hazelnuts, and almonds), many herbs and spices, grains, and dark chocolate. A dietary deficiency of antioxidants can accelerate cell death and mitochondrial breakdown, contributing to the development of chronic diseases and other disorders. Antioxidant deficiency increases oxidative stress and, as a consequence, leads to mitochondrial dysfunction and age-related diseases, including metabolic syndrome.

[0046] Flavonoids: Flavonoids are ubiquitous in plant foods and structurally exhibit variations in the C-ring, characterizing different types, namely flavonols, flavones, isoflavones, flavonones, flavanols, and anthocyanins. Flavonoids are present in a wide variety of fruits and vegetables as secondary plant metabolites and have significant impact on the prevention of many human diseases. Flavonoids are a widespread compound in plants that not only have properties related to food quality, such as color and aroma, but may also have potential health benefits, including a reduced risk of cancer.

[0047] Anthocyanins: Anthocyanins are polyphenolic compounds belonging to the flavonoid family. They are colored (blue-red) pigments found in abundance in many fruits, vegetables, and plants. They are known to possess antioxidant activity. They readily donate hydrogen, forming relatively stable structures with unpaired electrons, and chelate transition metals such as iron. In the context of the nervous system, anthocyanins have been shown to improve motor and cognitive function in experimental animals and prevent apoptotic neuronal death mediated by reactive oxygen species. Disruption of mitochondrial protein integrity may contribute to the development of neurodegenerative diseases, as well as other apoptogenic mitochondrial disorders.There is evidence that damage to cytochrome c, a protein in the electron transport chain, can lead to these disorders and increase oxidative stress, respiratory chain dysfunction, and apoptotic cell death. Furthermore, dopamine oxidation in neurons can lead to the formation of reactive oxygen species (ROS) and increase oxidative stress, reduce the properties of cytochrome c, and, by disrupting the normal cytochrome redox cycle, contribute to dopaminergic neurodegeneration.

[0048] Hawthorn contains a large number of biologically active substances: triterpene saponins—derivatives of oleic, ursolic, and crategic acids—increase blood flow in the coronary and cerebral vessels and increase the heart's sensitivity to cardiac glycosides. Hawthorn preparations contain flavonoids, hyperoside, quercetin, and vitexin, which (especially in combination with ascorbic acid) reduce capillary permeability and fragility, participate in oxidation-reduction processes, and inhibit the action of hyaluronidase.

[0049] Hawthorn berries contain a significant amount of fiber and pectin, hawthorn is especially rich in pectin substances (1.8-6%), protopectin (50-60% of the total pectin substances), which are able to adsorb and remove certain toxins, heavy metal salts, including their radioactive isotopes from the body. Hawthorn berries contain organic acids - including crataegus, citric, tartaric, ursolic, chlorogenic, oleanolic and caffeic acids; amino acids. Hawthorn contains fructose (7-14%), glucose and sucrose (1.6-6%), sorbitol (8-25% based on the dry weight of the fruit). Hawthorn contains flavonoids (quercetin, hyperin, hyperoside, vitexin, catechins (1.2-1.7%), amines, choline, triterpene and flavonoid glycosides, acetylcholine, tannins and extractive substances, carotene (provitamin A) - 0.24-0.5 mg% and vitamin C (15-40 mg%), essential oil.Hawthorn contains anthocyanin pigments (31-246 mg%), and a relatively high content of leucoanthocyanins (400-1200 mg%). Proteolytic enzymes, phytoncides, and proteins have also been found. The pharmacological activity of hawthorn is associated with its flavonoids, which have cardiotonic, coronary dilator, hypotensive, and antiarrhythmic effects. The antispasmodic effect of hawthorn is attributed to the presence of triterpene compounds and glycosides in the plant. The presence of these substances also determines their effect on venous pressure and improved vascular function.

[0050] The main group of active substances in hawthorn are procyanidins, which have a cardiotonic, antiarrhythmic, hypotensive effect, reduce the excitability of the heart muscle, have antioxidant activity, which is often used in the complex therapy of functional disorders of cardiac activity, cardialgia, climacteric syndrome, hypertension, astheno-neurotic conditions.

[0051] The main active ingredient in peppermint preparations is menthol, found in the plant's essential oil. In addition to the essential oil, peppermint contains terpenoids (limonene, cineole, dipentene), carotene, rutin, ascorbic, ursolic, and oleanolic acids, flavonoids, tannins, and trace elements. Menthol, extracted from peppermint oil, is used to treat angina, is an ingredient in nasal drops and ointments, and migraine pencils. It is also used in the production of a number of medications, including validol, valocordin, ingafen, olimetin, Zelenin drops, and others, used to treat conditions associated with spasms of the coronary vessels and smooth muscles.

[0052] Motherwort herb contains flavonoids: rutin, quercetin, quercetrin, 7-quercetin glucoside, hyperoside, quinqueloside; iridoids: ajugol, ajugoside, harpagide and harpagide acetate; alkaloids: stachydrine or leonuricardine; sugars, diterpenoids: ursolic acid, essential oil: cardiophyllene, A,-humulene, H-pinene, O-pinene, linalool, limonene, vitamins: ascorbic acid, tannins, phenolic carboxylic acids and their derivatives. Flavonoids were previously considered the main group of active substances of motherwort. However, it has now been proven that the action of iridoids predominates. It has been established that 54 leaves contain 0.52% iridoids, or 41.87% of the total, flowers 0.44%, and stems 0.28%, based on dry matter. Motherwort and its preparations possess pronounced sedative properties. Motherwort herb has hypotensive and cardiotonic effects.Motherwort preparations are used in medical practice as a cardiotonic, heart rhythm-regulating, and sedative. Motherwort preparations are prescribed to patients suffering from cardiosclerosis, hypertension, angina, myocarditis, and cardiac neurosis.

[0053] Rose hips contain a large amount of vitamins, especially vitamin C (at least 0.2%) and vitamins P and K, flavonoids, carotenoids, tannins, and pectin. They have a general tonic effect, stimulate the body's nonspecific resistance to harmful effects, accelerate tissue regeneration, reduce vascular permeability, positively affect carbohydrate and mineral metabolism, and have anti-inflammatory properties. They enhance humoral and cellular immunity. They have a choleretic effect due to the presence of organic acids and flavonoids. In terms of chemical composition and nutritional value, rose hips are superior to all wild fruits and berries. The total dry matter content is 40%, including easily digestible sugars - 10%, proteins - 1.6%, organic acids - 2.3%, ash content is 2.2%. Of the mineral substances it contains, in mg%: sodium - 5, potassium - 23, calcium - 28, magnesium - 8, phosphorus - 8.The fruit is distinguished by its rich iron content – ​​11.5 mg%, which is significantly more than in all cultivated and wild fruits and berries (citrus fruits contain from 0.1 to 0.6 mg% iron, apples – 2.2 mg, black currants – 1.3 mg, and strawberries – 1.2 mg%). The daily intake of vitamin C is 50-100 mg. Products containing 50-100 mg% of this vitamin are considered high-vitamin. Rose hips, on average, contain 650 mg% of this vitamin, that is, 10 times more than everyday vegetables. The effectiveness of rose hips is explained by the combined effect of its constituents. Isoflavonoids and kaempferol exhibit a diuretic effect, rutin in combination with vitamin P strengthens capillaries, and quercetin has a pronounced hemostatic effect. Tannins, found not only in the fruits but also in other parts of the plant, demonstrate their bactericidal, anti-inflammatory and astringent properties.

[0054] The declared composition of the instant tea drink for gerodietetic nutrition of people suffering from cardiovascular diseases (hereinafter referred to as the tea drink) and the proposed percentage ratio of its components are selected based on the requirements for the quantitative and qualitative content in the human body of the necessary amount of vitamins and nutrients for active longevity, as well as based on the type and technological properties of the components.

[0055] Efficiency:

[0056] The tea drink has a pronounced hypotensive, anti-atherosclerotic and antioxidant effect.

[0057] The combination of flavonoids and vitamins (C, A, E, B₁) provides correction of micronutrient deficiency in the elderly.

[0058] Organoleptic properties (sweet taste, citrus aroma) increase consumer appeal.

[0059] Brief description of drawings

[0060] For a more visual presentation of the results of the quality of life study, the figure shows a diagram of the dynamics of the quality of life of patients under the influence of diet therapy with the inclusion of instant tea drink for gerodietetic nutrition of people suffering from cardiovascular diseases.

[0061] Implementation of the invention

[0062] Method for preparing instant tea drink for gerodietetic nutrition of people suffering from cardiovascular diseases).

[0063] The method for producing a tea drink includes: receiving raw materials and components; storing raw materials and components, preparing for use; preparing a multi-component dry mixture; mixing; packaging the product.

[0064] A multi-component dry (powder) mixture is prepared in a mixer, ensuring uniform distribution of all components.

[0065] The prepared components are fed through a weighing device into a mixing bin. The components are added to the mixing bin in a specific sequence, starting with the base component, which has the largest proportion, in a ratio of 10:1 and mixed.

[0066] The mixture is mixed for at least (10-20) minutes, then pneumatically transported into the hopper of the filling machine.

[0067] The product is packaged in sealed consumer containers (in the form of sachets) with a net weight of 1.0 g.

[0068] When using, dissolve the sachet in 100 ml of boiled water at room temperature. The daily dosage should be discussed with a physician.

[0069] The invention is illustrated by the following examples of specific implementation.

[0070] Example 1

[0071] Dry extract of hawthorn fruits 15,0 Dry extract of peppermint leaves 5,2 Dry extract of motherwort herb 3,6 Dry extract of rose hips 3,7 Vitamin C 6,5 Thiamine chloride (vitamin B₁) 0,15 Vitamin A 0,1 Vitamin E 1,5 Isomalt 45,25 Crystalline fructose 18,5 Natural citrus flavoring 0,5 Example 2 Dry extract of hawthorn fruits 16,0 Dry extract of peppermint leaves 5,0 Dry extract of motherwort herb 3,0 Dry extract of rose hips 3,5 Vitamin C 6,2 Thiamine chloride (vitamin B₁) 0,12 Vitamin A 0,11 Vitamin E 1,6 Isomalt 45,5 Crystalline fructose 18,47 Natural citrus flavoring 0,5

[0072] Example 3

[0073] Dry extract of hawthorn fruits 15,5 Dry extract of peppermint leaves 4,5 Dry extract of motherwort herb 3,5 Dry extract of rose hips 4,0 Vitamin C 7,0 Thiamine chloride (vitamin B₁) 0,11 Vitamin A 0,1 Vitamin E 1,4 Isomalt 44,69 Crystalline fructose 19 Natural citrus flavoring 0,5

[0074] Clinical trials were conducted on the claimed instant tea drink for gerodietetic nutrition of people suffering from cardiovascular diseases.

[0075] Purpose of the study:

[0076] To evaluate the tolerability and effectiveness of diet therapy with the inclusion of instant tea drink (preventive product) for gerodietetic nutrition of people suffering from cardiovascular diseases

[0077] Research objectives:

[0078] • To evaluate the tolerability of diet therapy with the inclusion in the diet of a preventive product for gerodietetic nutrition of people suffering from cardiovascular diseases";

[0079] • To evaluate the dynamics of quality of life indicators against the background of the inclusion in the diet of a preventive product for gerodietetic nutrition of people suffering from cardiovascular diseases";

[0080] The study was conducted in the Department of Cardiovascular Pathology and Diet Therapy. Based on screening results, 48 ​​patients with cardiovascular diseases (coronary heart disease and / or hypertension) were selected.

[0081] Inclusion criteria:

[0082] Patients included in this study must meet the following criteria: 58 years old and no more than 85 years old;

[0083] • Presence of cardiovascular disease;

[0084] Non-inclusion criteria:

[0085] Patients with at least one of the following symptoms cannot be included in the study:

[0086] • Treatment with any other investigational drug within the last 30 days prior to inclusion in this study;

[0087] • Use of a specialized food product (SFP) with a targeted hypolipidemic and antiatherogenic effect for 6 months prior to inclusion in the study;

[0088] • Taking dietary supplements and medications to control and reduce body weight and blood lipids;

[0089] • Anemia;

[0090] • Fever;

[0091] • Exacerbation of a chronic disease;

[0092] • Chronic renal failure;

[0093] • Acute and / or decompensated chronic cardiovascular pathology;

[0094] • Insulin therapy for diabetes mellitus.

[0095] MATERIALS AND METHODS

[0096] Patients were randomly assigned (by coin tossing) to two groups that differed in the method of dietary treatment.

[0097] Patients of the main group (MG) – 24 people (with an average age of 66.2 ± 4 years) – for 30 days on an outpatient basis received the basic version of the standard diet (OVD) with the inclusion of 100 ml of a prophylactic product for gerodietetic nutrition.

[0098] Patients of the control group (CG) – 24 people (with an average age of 63.6±6.15 years) - in parallel with the patients of the main group, they received only the main version of the standard diet (OVD).

[0099] OVD - a low-fat, normal protein, complex carbohydrate diet with limited easily digestible carbohydrates. Nitrogenous and extractive substances, table salt (6-8 g / day), and foods rich in essential oils are limited. Hot spices, spinach, sorrel, and smoked foods are excluded. Meals are boiled, stewed, baked, pureed, mashed, and steamed. Food temperature is from 15° to 60–65ºC. Free liquid – 1–1.5 liters. Meals are fractional, 4–6 times a day.

[0100] Chemical composition: proteins - 85-90 g, including animal 40-45 g; total fats - 70-80 g, including vegetable 25-30 g; total carbohydrates - 300-330 g, dietary fiber - 30 g. Energy value 2170-2400 kcal (Table 1).

[0101] Table 1 - Chemical composition and energy value of a standard diet.

[0102] Diets Proteins, g, including animal Total fats, g, including vegetable Total carbohydrates, g, including mono- and disaccharides Energy value, kcal Chemical composition and energy value of the diet 85-90 (45-50) 70-80 (25-30) 300-330 (30-40) 2170-2400

[0103] All patients were given printouts with a 7-day version of the OVD to carry out the necessary dietary therapy.

[0104] The study prophylactic product (Table 2) was included in the diet at a dosage and daily regimen whose efficacy and safety were confirmed in preclinical studies. Patients in the primary group took 1 g of the product per day (diluted in 100 ml of boiled, cooled water) for 30 days.

[0105] Table 2 - Composition of the preventive product for gerodietetic nutrition of people suffering from cardiovascular diseases.

[0106] Ingredients Amount of ingredients (g) per 100 g Dry extract of hawthorn fruits 15,0 Dry extract of peppermint leaves 5,5 Dry extract of motherwort herb 3,5 Dry extract of rose hips 3,5 Vitamin C 6,5 Thiamine chloride (vitamin B1) 0,15 Vitamin A 0,1 Vitamin E 1,5 Isomalt 45,25 crystalline fructose 18,5 natural citrus flavoring 0,5 Total: 100

[0107] Drug therapy was carried out in accordance with standard drug regimens for diseases of the therapeutic profile.

[0108] The study of patients' quality of life was conducted using the SF-36 Health Status Survey quality of life scale [Ware JE, Snow KK, Kosinski M., Gandek B. SF-36 Health Survey. Manual and interpretation guide / / The Health Institute, New England Medical Center. Boston, Mass.-1993.] The SF-36 is a non-specific questionnaire for assessing quality of life (QOL) and is widely used in quality of life studies in the United States and Europe. The Institute for Clinical and Pharmacological Research (St. Petersburg) translated and validated the methodology.

[0110] The SF-36 questionnaire was standardized for the general US population and representative samples in Australia, France, and Italy. In the US and European countries, studies of individual populations were conducted, and results were obtained on norms for the healthy population and for groups of patients with various chronic diseases (with the identification of groups by gender and age) [Ware JE, Kosinski M., Keller SD SF-36 Physical and Mental Health Summary Scales: A User`s Manual / / The Health Institute, New England Medical Center. Boston, Mass.-1994].

[0111] The 36 items of the questionnaire are grouped into eight scales: physical functioning, role functioning, physical pain, general health, vitality, social functioning, emotional state, and mental health. The values ​​for each scale range from 0 to 100, with 100 representing complete health. All scales comprise two dimensions: mental and physical well-being. Results are presented as scores on the eight scales, constructed so that higher scores indicate higher levels of QOL.

[0112] The following indicators are quantitatively assessed:

[0113] 1. Physical Functioning (PF), reflecting the extent to which the patient's physical condition limits the performance of physical activities (self-care, walking, climbing stairs, carrying heavy objects, etc.). Low scores on this scale indicate that the patient's physical activity is significantly limited by their health condition.

[0114] 2. Role-Physical Functioning (RP) – the impact of physical condition on everyday role activities (work, performing daily duties). Low scores on this scale indicate that everyday activities are significantly limited by the patient's physical condition.

[0115] 3. Pain intensity (BP) and its impact on the ability to perform daily activities, including work at home and outside the home. Low scores on this scale indicate that pain significantly limits the patient's activity.

[0116] 4. General Health (GH) - the patient's assessment of their current health and treatment prospects. The lower the score on this scale, the lower the perceived health status.

[0117] 5. Vitality (VT) refers to the feeling of being full of energy and strength, or, conversely, exhausted. Low scores indicate fatigue and decreased vitality.

[0118] 6. Social Functioning (SF) is defined as the extent to which physical or emotional state limits social activity (communication). Low scores indicate a significant limitation of social contacts and a decrease in the level of communication due to deterioration of physical and emotional state.

[0119] 7. Role-Emotional Functioning (RE) involves assessing the extent to which one's emotional state interferes with work performance or other daily activities (including greater time expenditure, decreased work volume, decreased work quality, etc.). Low scores on this scale are interpreted as a limitation in performing daily work due to a deterioration in one's emotional state.

[0120] 8. Mental Health (MH) characterizes mood, depression, anxiety, and a general indicator of positive emotions. Low scores indicate the presence of depressive and anxious experiences, and mental ill-being [A.O. Nedoshivin, A.E. Kutuzova, N.N. Petrova, S.Yu. Varshavsky, N.B. Perepech, A study of the quality of life and psychological status of patients with chronic heart failure / / Heart failure: Vol. 1 / N 4 / 2000].

[0121] The scales are grouped into two indicators: “physical component of health” and “psychological component of health”:

[0122] 1. Physical health (PH)

[0123] Scale components:

[0124] • Physical functioning,

[0125] • Role functioning due to physical condition

[0126] • Pain intensity

[0127] • General health

[0128] 2. Mental Health (MH)

[0129] Scale components:

[0130] • Mental health

[0131] • Role functioning determined by emotional state

[0132] • Social Functioning

[0133] • Vital activity

[0134] For all scales, in the complete absence of limitations or health problems, the maximum value is 100. The higher the score on each scale, the better the quality of life for that parameter.

[0135] Before calculating the indicators of the 8 scales, the responses were recoded (the procedure for recalculating the raw scores of the questionnaire into QOL scores), then to obtain the values ​​of each scale.

[0136] The calculation of the quality of life scores for each of the 8 “transformed” scales was carried out using the formula

[0137] Transformed scale = ([X - Min] / [Max - Min]) x 100, where:

[0138] X - total scale count;

[0139] Min - the minimum possible value of the scale;

[0140] Max - the maximum possible value of the scale /

[0141] The mean values ​​and standard deviations for each scale were then calculated.

[0142] The tolerance of the product as part of diet therapy was assessed using a scale consisting of 4 points:

[0143] 1) very good: no adverse events (AE) occurred, the product is easy to use;

[0144] 2) good (no adverse events occurred, the patient is dissatisfied with one of the product characteristics: release form, dosage regimen, taste, smell, packaging, etc.);

[0145] 3) satisfactory (AEs occurred that did not require discontinuation of the product);

[0146] 4) unsatisfactory (AEs occurred that required product discontinuation).

[0147] The product's organoleptic properties were assessed using a 5-point scale. The product's taste, smell, color, consistency, and appearance were assessed.

[0148] Statistical data processing was performed using the AnalystSoft Inc. StatPlus statistical analysis program (version 5). After testing for normal distribution, the data are presented as M ± SD, where M is the mean value and SD is the standard deviation. The significance of differences between study groups was determined using Student's t-test. Differences were considered statistically significant at ρ < 0.05.

[0149] RESULTS OF THE STUDY

[0150] Showed subjective good tolerability and safety of diet therapy with the inclusion of instant tea drink for gerodietetic nutrition of people suffering from cardiovascular diseases (Table 3).

[0151] Table 3 – Assessment of tolerability of the diet therapy

[0152] Indicators KG OG Points on a 5-point scale Dyspepsia: 1. belching 2. nausea 3. heartburn 4. bitterness in the mouth 0 0 0 0 0 0 0 0 Stomach ache 0 0 Allergic reactions 0 0

[0153] The organoleptic evaluation of the drink included an assessment of odor, color, consistency, and appearance. All patients (in both the treatment and control groups) rated the product's excellent taste, pleasant odor, and good color and appearance. Overall, the organoleptic properties of the gerodietetic drink were rated by patients as "excellent" (Table 4).

[0154] Table 4 – Organoleptic evaluation of instant tea drink for gerodietetic nutrition of people suffering from cardiovascular diseases.

[0155] Indicators KG OG Points on a 5-point scale Taste 5 5 Smell 5 5 Color 5 5 Consistency 5 5

[0156] The results of the assessment of the quality of life of patients before and after the course of diet therapy are presented in Table 5.

[0157] Table 5 – Dynamics of the quality of life of patients under the influence of diet therapy with the inclusion of instant tea drink for gerodietetic nutrition of people suffering from cardiovascular diseases.

[0158] Indicator KG Δ, % OG Δ, % Physical component of health Physical functioning d p 54,42±21,05 55,83±27,05 1 51,67±28,2 57,08±29,08 10 Role functioning (physical) d p 35,83±36,58 38,33±41,59 7 40,63±44,12 48,33±46,17* 19 Intensity of pain d p 54,13±21,76 67,88±24,67** 25 55,17±23,74 69,96±23,64** 27 General health d p 54,79±15,14 57,5±14,14 5 54,79±18,62 58,75±18,19 7 Psychological component of health Mental health d p 66,08±17,82 72,00±17,54 9 64,33±19,56 75,33±14,90** 17 Role functioning (psych) d p 70,29±32,88 85,29±22,89 21 52,79±43,92 73,58±38,10 39 Social functioning d p 61,67±23,54 70,50±25,28 14 69,50±24,79 85,17±17,99** 22 Vital activity d p 51,67±20,83 58,13±22,45 12 54,38±22,67 66,04±19,56* 21

[0159] It is noteworthy that before the intervention, patients in both study groups showed low quality of life values ​​on all analyzed scales, expressed to the same extent in both groups.

[0160] After the course of diet therapy, an increase in the level of quality of life was noted in both study groups across all analyzed scales. Moreover, significantly greater dynamics of the studied parameters were revealed in patients in the MG. In particular, this concerns an increase of 19% (ρ < 0.05) in the scores of the physical component of role functioning scale, an increase of 27% (ρ < 0.01) in the scores of the pain intensity scale, an increase of 17% (ρ < 0.01) in the scores of the mental health scale, an increase of 22% (ρ < 0.01) in the scores of the social functioning scale and an increase of 21% (ρ < 0.05) in the scores of the life activity scale.

[0161] For a more visual presentation of the results of the quality of life study, the figure shows a diagram of the dynamics of the quality of life of patients under the influence of diet therapy with the inclusion of a soluble tea drink for gerodietetic nutrition of people suffering from cardiovascular diseases.

[0162] Analysis of the dynamics revealed the following. Significant dynamics in the studied parameters are clearly visible in patients in the MG, with statistically significant results (ρ<0.05 and ρ<0.01) for most of the analyzed scales.

[0163] CONCLUSION

[0164] Thus, clinical testing of the drink (soluble tea drink for gerodietetic nutrition of people suffering from cardiovascular diseases) in patients suffering from cardiovascular diseases allowed us to draw a number of conclusions:

[0165] 1. Favorable organoleptic properties of a preventative product for gerodietetic nutrition of people suffering from cardiovascular diseases have been noted.

[0166] 2. The course of diet therapy with its inclusion was well tolerated

[0167] 3. A significant improvement in the quality of life of patients with cardiovascular diseases was recorded after a course of dietary therapy including the tested product.

[0168] 4. The obtained results of the study allow us to recommend the use of the tested product – an instant tea drink for gerodietetic nutrition for people suffering from cardiovascular diseases – for the purpose of secondary prevention and improving the quality of life of patients.

[0169] The food safety of the packaging of the declared tea drink was proven in the process of laboratory tests for microbiological indicators and safety indicators in accordance with: GOST 30178-96, GOST 26930-86, GOST 34427-2018, GOST 10444.15-2013, GOST 31747-2012, GOST 10444.12-2013.

[0170] A deviation upward or downward from the declared values ​​of all the specified parameters of the composition of the declared tea drink leads to a decrease in its biological and nutritional value, a deterioration in its preventive, functional properties and digestibility.

[0171] The invention can be used in the food industry for mass production of specialized products, as well as in medical and gerontological institutions for dietary preventive nutrition.

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