Dietary supplement

Abstract

The invention relates to a dietary supplement in capsule form containing, as active ingredients, a combination consisting of 45-50 g magnesium bisglycinate, 590-600 mg magnesium citrate, 2-3 mg vitamin B1 and 2-3 mg vitamin B6, and containing, as excipients, lecithin and gum arabic.

Description

[0001] BIOLOGICALLY ACTIVE SUPPLEMENT

[0002] Field of technology

[0003] The invention relates to the field of biologically active additives for the prevention of metabolic syndrome, which help reduce stress levels in the body, normalize body mass index, improve overall well-being and increase energy levels, normalize biochemical parameters of the blood (glucose, CIC, LDL), reduce the overall inflammatory load of the body, and are also used to prevent metabolic disorders and cardiovascular diseases, including arterial hypertension, coronary heart disease, rhythm disturbances, cerebrovascular diseases, peripheral arterial diseases, heart failure and diabetes mellitus.

[0004] Prior art

[0005] Document US20220079201A1 discloses the creation of a vitamin and mineral composition for pregnant women, which includes, among other things, vitamins B1, B6 and magnesium. Magnesium can be included in the composition in one of the selected forms, such as: acetate, citrate, gluconate, stearate, chloride and others. The composition can be used to restore the nutritional deficiency observed in patients during physiologically stressful conditions, which, in certain embodiments of the invention, include prenatal, pregnant and lactating women.

[0006] Document US8329227B2 discloses a composition aimed at improving cognitive functions, which includes B vitamins, including vitamins B1 and B6. The authors propose the use of several non-competing sources of magnesium for its better absorption. In the first case, such sources can be: bisglycinate, gluconate, lactate, phosphate, etc. In the second case: oxide, malate, citrate, etc. This supplement can be used to improve and maintain memory, attention, concentration and mood. However, magnesium oxide is known to have extremely low bioavailability compared to other forms and salts of this mineral. Magnesium citrate has repeatedly demonstrated better absorption compared to magnesium oxide and chelate

[0018] . Magnesium bisglycinate is highly absorbed in vitro and shows better bioavailability than oxide, citrate and phosphate

[0017] .

[0007] Thus, it is clear that despite the presence of a large number of products containing magnesium and vitamin complexes on the biological supplements market, consumers still need products aimed at preventing metabolic syndrome, reducing the overall inflammatory load on the body and restoring glucose metabolism, as well as reducing the effects of stressful situations. One of the solutions is to provide a composition according to the present invention, consisting of magnesium citrate, magnesium bisglycinate, vitamin B6 and vitamin B1.

[0008] The essence of the invention

[0009] The invention relates to a biologically active supplement in the form of a capsule containing as active substances a combination consisting of magnesium bisglycinate - 45-50 mg, magnesium citrate - 590-600 mg, vitamin B1 - 2-3 mg, vitamin B6 - 2-3 mg, and containing lecithin and gum arabic as auxiliary substances.

[0010] Detailed description of the invention

[0011] General information about the invention.

[0012] Magnesium is essential for the proper functioning of muscles and nerves. It helps transmit electrical impulses between nerves and muscles, allowing contraction and relaxation. Magnesium is involved in numerous enzymatic reactions that are involved in the production and utilization of ATP (adenosine triphosphate), a molecule responsible for the storage and release of energy in the body. Magnesium plays a crucial role in bone formation and helps regulate calcium levels in the body. This helps maintain strong and healthy bones. It is involved in the production of proteins that are necessary for growth, repair, and many other physiological processes. Sufficient magnesium levels promote relaxation of blood vessels, helping to regulate blood pressure. Magnesium is necessary for the synthesis, stability, and repair of genetic material (DNA and RNA).It plays an important role in carbohydrate metabolism and helps improve insulin sensitivity, promoting normal blood sugar levels.

[0013] Magnesium bisglycinate is a special form of magnesium supplement in which a magnesium atom is bonded to two molecules of the amino acid glycine. This chelated form of magnesium is highly bioavailable, meaning it is easily absorbed by the body. Chemically, magnesium bisglycinate has the formula HeMgNzC^. It is a white powder that is soluble in water. It is a stable compound that does not break down easily under normal conditions. Magnesium bisglycinate is often preferred as a supplement over other forms of magnesium due to its improved absorption and reduced gastrointestinal side effects. Because it is chelated with glycine, it bypasses the typical digestive process, reducing the likelihood of digestive discomfort or diarrhea, which can be a common side effect of other magnesium supplements. Additionally, magnesium bisglycinate is considered well-tolerated and safe for most people when taken at recommended dosages.It has no known drug interactions and may be helpful for people with magnesium deficiency, muscle spasms, migraines, or those who need extra magnesium.

[0014] Magnesium citrate is a chemical compound commonly used as a dietary supplement, laxative, and antacid. It consists of magnesium combined with citric acid, which gives it its name. Chemical formula: CuHioMgjOu. It is a white, odorless powder with a slightly acidic taste. It dissolves slowly in cold water, and dissolves well in hot water. Mg 2 * is responsible for many functions in the body, magnesium citrate has a wider range of pharmacological action. More than three hundred different enzymes in the body depend on magnesium, and therefore its deficiency is an important pathogenetic factor in the development of diseases. The content of pure (elementary) Mg 2* magnesium citrate contains approximately 11%.

[0015] The authors of the present invention have developed a dietary supplement comprising magnesium bisglycinate (preferably 50 mg / capsule) and citrate (preferably 594 mg / capsule). Magnesium bisglycinate is presented in the supplement as Magnesium bisglycinate 10% Albion®. The dietary supplement is preferably in the form of a capsule. The use of the dietary supplement according to the invention prevents metabolic syndrome, helps reduce stress levels in the body, normalizes body mass index, improves overall well-being and increases energy levels, normalizes biochemical blood parameters (glucose, CIC, LDL), reduces the overall inflammatory load of the body, and is also used to prevent metabolic disorders and cardiovascular diseases, including arterial hypertension, coronary heart disease, rhythm disturbances, cerebrovascular diseases, peripheral arterial diseases, heart failure and diabetes mellitus.

[0016] There is currently a wide range of magnesium supplements on the market. Magnesium is available in various forms: magnesium lactate dihydrate, magnesium citrate, magnesium bisglycinate, magnesium aspartate, magnesium oxide, magnesium gluconate, magnesium orate dihydrate. These forms of magnesium differ in their bioavailability for the body [I]. On average, the daily requirement for magnesium is 3 to 5 mg / kg of body weight. The main source of magnesium in the body comes from cereals, but this is usually still not enough to meet the daily requirement. Mild magnesium deficiency can be asymptomatic or cause seizures, anxiety, depression, tremor, myoclonus, tetany, arrhythmia, tachycardia, or severe fibrillation. Elemental magnesium can bind to organic or inorganic molecules to form compounds. The behavior of the various complexes formed is different.The solubility of organic complexes is usually higher, and the degree of ionization is less dependent on pH than inorganic complexes [2]. A number of studies have been aimed at comparing the bioavailability of various forms for the purpose of their subsequent applicability in various biological supplements. For example, it has been shown that magnesium citrate is absorbed several times better than magnesium oxide due to its high solubility [I]. Inorganic magnesium salts were practically not absorbed by elderly people, since due to their age they had achlorhydria, which prevents ionization and solubility of inorganic salts

[0012] .

[0017] Along with magnesium citrate and bisglycinate, the dietary supplement also includes vitamin B6 (preferably 2.24 mg / capsule) and vitamin B1 (preferably 2.06 mg / capsule), which have properties similar to magnesium both individually and in combination with each other. Pyridoxine hydrochloride, also known as vitamin B6, is a water-soluble vitamin. It is an essential nutrient for the human body, which means that it cannot be synthesized and must be obtained through diet or supplements. Chemically, pyridoxine hydrochloride is the hydrochloride salt of pyridoxine. Its chemical formula is CgHuClNOs and its molecular weight is 205.64 g / mol. Pyridoxine hydrochloride plays a vital role in numerous biochemical reactions in the body. It serves as a coenzyme in more than 100 enzymatic reactions involved in protein metabolism, amino acid synthesis, and the production of neurotransmitters such as serotonin and dopamine.This vitamin is also involved in the synthesis of hemoglobin, which carries oxygen in the blood. The human body needs pyridoxine hydrochloride for normal brain development and function, as well as for the proper functioning of the nervous system. It is involved in the metabolism of carbohydrates, fats, and proteins, helping to convert these macronutrients into energy. Vitamin B6 also helps maintain healthy skin, hair, and eyes. In addition, pyridoxine hydrochloride helps synthesize DNA and RNA, the body’s genetic material. It also supports the immune system by promoting antibody production and maintaining its proper function. Overall, pyridoxine hydrochloride is essential for growth, development, and overall health. Although it is found in many foods, such as meat, fish, poultry, bananas, and leafy greens, supplements are sometimes necessary for people with deficiencies or certain medical conditions.

[0018] Thiamine hydrochloride, also known as vitamin B1 hydrochloride, is a synthetic form of thiamine (vitamin B1). Thiamine is an essential water-soluble vitamin that plays a critical role in glucose metabolism. It is involved in various biochemical reactions in the body, especially in the production of energy from carbohydrates. Chemically, thiamine hydrochloride is a white crystalline powder that is highly soluble in water. It has a molecular formula of C12H17CIN4OS and a molecular weight of 337.27 g / mol. Thiamine hydrochloride is stable when exposed to air and light, but is sensitive to heat and alkalis. Thiamine hydrochloride is important to the human body because it acts as a coenzyme for several enzymes involved in carbohydrate metabolism, particularly the conversion of glucose into energy. It helps convert glucose into a form that cells can use to produce energy.Thiamine is also necessary for the proper functioning of the nervous system and the synthesis of neurotransmitters. Thiamine deficiency can lead to a condition known as beriberi, which is characterized by symptoms such as weakness, weight loss, irritability, confusion, and cardiovascular problems. Thiamine deficiency can occur in people with poor diet, alcoholism, or certain medical conditions.

[0019] Also additional ingredients of the present invention are lecithin and gum arabic.

[0020] Lecithins are a mixture of phosphatide fractions obtained from animal or plant raw materials by physical or enzymatic methods. We have found that lecithins can be natural analogues of anti-caking agents (magnesium stearate, silicon dioxide, etc.). Natural lecithins have GRAS status in Europe, the USA and Japan. Their use in food products is not limited. Lecithins perform not only a technological function, but are also lipotropic compounds, i.e. they improve the functioning of the liver and gall bladder due to the fact that lecithins contain phosphatidylcholine (up to 25%).

[0021] Lecithins, or more precisely products with a high lecithin content, are prescribed for diet No. 5 (liver diseases, gallbladder diseases, cirrhosis, cholecystitis, hepatitis).

[0022] Lecithins directly affect the health of the nervous system, improve cognitive abilities, and reduce the risk of neurodegenerative diseases.

[0023] Phosphatidylcholine, which is part of lecithins, can be built into the cell membranes of neurons, "envelops" the axon in the neuron (the myelin sheath of the axon). A lack of lecithin in the diet leads to sclerosis, autoimmune diseases associated with the destruction of myelin, and leads to impaired coordination of movement and balance.

[0024] Magnesium in combination with lecithin and B vitamins has a complex effect on the health of the nervous system.

[0025] Gum arabic is a mixture of potassium, calcium and magnesium salts of arabic acid. Otherwise known as acacia gum or acacia gum. It performs the technological function of a stabilizer. We have found that gum arabic can be a natural analogue of synthetic fillers (for example, modified types of cellulose). Gum arabic improves the fluidity of dry mixes and reduces dust formation of active ingredients. Gum arabic not only performs a technological function, but also has nutritional value. It is a rich source of dietary fiber (prebiotic), positively affecting the functioning of the intestines. Gum arabic is fermented by bacteria in the large intestine, forming metabolites - SCFA (short-chain fatty acids - propionates, butyrates). SCFA, in turn, can modulate the central nervous system - affect mood, behavior and emotions (activation of the "gut-brain" axis).

[0026] As a prebiotic, gum arabic also helps restore normal intestinal microflora, supports the energy supply of colonocytes, reducing the risk of intestinal hyperpermeability, and reduces inflammation.

[0027] Gum arabic, by normalizing the functioning of the gastrointestinal tract, promotes better absorption of magnesium and B vitamins, and also activates the “gut-brain” axis, thereby enhancing the effect of magnesium.

[0028] The recommended dosage of the dietary supplement containing the active complex is preferably 4 capsules / day.

[0029] The invention will now be described in detail with emphasis on the technical results achieved, which are not only explicitly stated but can also be deduced by those skilled in the art from the experimental data presented.

[0030] Metabolic syndrome.

[0031] Metabolic syndrome, also known in the literature as syndrome X, insulin resistance, etc., is not a single disease but a collection of cardiovascular risk factors, and is defined somewhat differently by different organizations

[0015] . Despite this, they all agree that the main features of metabolic syndrome are: elevated blood glucose levels, high triglyceride levels, and excess weight. It is a complex pathophysiological condition that occurs primarily due to an imbalance in calorie intake and energy expenditure, but also depends on genetic / epigenetic factors, the prevalence of a sedentary lifestyle, the quality and composition of food consumed, and the composition of intestinal microbes. The main companion of metabolic syndrome is insulin resistance. Insulin is produced by the pancreas in response to hyperglycemia and stimulates glucose use in different tissues in different ways.The tissues that remove glucose from the circulation and influence glucose uptake the most are skeletal muscle, liver, and adipose tissue. In skeletal muscle and adipose tissue, insulin stimulates glucose uptake. In skeletal muscle and liver, insulin stimulates the synthesis of glycogen from glucose and inhibits glycogenolysis. In the liver, insulin also decreases hepatic gluconeogenesis, preventing more glucose from entering the circulation. In adipose tissue, insulin inhibits the breakdown of fat, or lipolysis, and stimulates glucose uptake. The net effect of all these changes is to increase glucose uptake, decrease circulating glucose levels, and increase the conversion of glucose to storage molecules, glycogen or fat [7]. In insulin resistance, fat, muscle, and liver cells respond inappropriately to insulin and circulating glucose levels remain high, leading to pathology. This is exacerbated by dysregulated feedback mechanisms.

[0032] Glucose homeostasis is the balance between glucose production by the liver and glucose uptake and utilization by peripheral organs. Increased glucose levels in the body can be a signal or prerequisite for the development of metabolic syndrome, but even if this does not happen, this change can lead to a number of other diseases associated with impaired carbohydrate metabolism

[0019] . Long-term elevated glucose levels can lead to diabetes mellitus if not properly treated. This chronic disease affects the body's ability to effectively regulate blood sugar levels. High blood sugar can damage blood vessels over time, increasing the risk of developing cardiovascular disease. In addition, it can lead to impaired kidney function and the development of retinopathy, which is a common cause of blindness in adults

[0014] .

[0033] The human body is designed to sense and respond to stress, which helps to facilitate the process of adaptation to new situations. It is widely known that stress can increase blood glucose levels and worsen glycemic control in both diabetic and non-diabetic patients. Physical stressors such as hypoxia, hypothermia, and sepsis have been shown to induce hyperglycemia [4-6]. Glucocorticoids (GCs) and catecholamines are the main hormonal response to stress. These hormones do not cause adverse effects in the acute phase, but in the long term, they can lead to impaired glucose homeostasis. This impaired glucose homeostasis can lead to chronic hyperglycemia, which leads to insulin resistance and type II diabetes

[0016] . Glucocorticoids act by stimulating gluconeogenesis and causing glycogen depletion.It interferes with the uptake and use of glucose by muscle and white adipose tissue, making hyperglycemia the most common and rapidly occurring side effect [9]. Administration of catecholamines results in increased glycolysis, increased glycogenolysis, and increased gluconeogenesis, and may cause suppression of insulin-mediated glycogenesis under physiological conditions, leading to hyperglycemia and hyperlactatemia [3]. In addition, stress may lead to changes in eating habits. Many people begin to consume large amounts of carbohydrates and sugars in stressful situations. Consuming large amounts of sugar may cause a sharp rise in blood glucose levels and a subsequent fall, causing a feeling of fatigue and irritability. Immune complexes are usually engulfed by phagocytes or macrophages immediately after their formation.However, if too many immune complexes are produced, this exceeds the capacity of phagocytes, and immune complexes can enter the blood in large quantities. Such immune complexes moving through the blood vessels are called circulating immune complexes (CIC). CIC are compounds that consist of specific immunoglobulins, complement components and antigen. They are formed during the reaction of binding antibodies to antigens as a result of the immune response to foreign antigens. The immune system's reaction can be directed both at antigens coming from outside (including viral, bacterial, parasitic infections) and at autoantigens formed during the natural processes of the body's vital activity or as a result of any pathological processes. Large CIC are excreted through the liver and spleen, the rest are captured and digested by phagocytes. If a large amount of antigen enters the body, the level of CIC also increases.Circulating complexes, under certain conditions (where blood flow is slow or filtration occurs, as well as with a decrease in their solubility), can be deposited on the membranes of small vessels and accumulate in tissues. The accumulation of immune complexes, their binding to complement factors and activation of the complement system lead to the induction of local inflammation and damage to organ tissues. The potential pathogenicity of CICs may depend on the nature of the antigens and antibodies included in their composition, size, rate of formation and elimination, solubility, and ability to bind complement. The content of CICs in the blood serum increases in various systemic disorders, such as rheumatological and autoimmune diseases, allergic diseases, viral, bacterial and parasitic infections and neoplasms [1, 13].A number of studies show that increased levels of CIC can also be observed in patients suffering from metabolic syndrome, in particular, in those who are overweight [8, 10].

[0034] Thus, the present invention in the first embodiment relates to a biologically active supplement containing a fixed combination of active substances. The active substances used are magnesium bisglycinate, magnesium citrate, vitamin B1, vitamin B6.

[0035] Preferably, the biologically active supplement according to the invention is in the form of a capsule.

[0036] Preferably, the biologically active supplement according to the invention contains a fixed combination of active substances consisting of magnesium bisglycinate from about 45 to about 50 mg, magnesium citrate from about 590 to about 600 mg, vitamin B1 from about 2 to about 3 mg, vitamin B6 from about 2 to about 3 mg.

[0037] More preferably, the biologically active supplement according to the invention contains a fixed combination of active substances consisting of magnesium bisglycinate from 45 to 50 mg, magnesium citrate from 590 to 600 mg, vitamin B1 from 2 to 3 mg, vitamin B6 from 2 to 3 mg.

[0038] Even more preferably, the biologically active supplement according to the invention contains a fixed combination of active substances consisting of about 50 mg magnesium bisglycinate, about 594 mg magnesium citrate, about 2.06 mg vitamin B1, about 2.24 mg vitamin B6.

[0039] Most preferably, the biologically active supplement according to the invention contains a fixed combination of active substances consisting of 50 mg magnesium bisglycinate, 594 mg magnesium citrate, 2.06 mg vitamin B1, 2.24 mg vitamin B6.

[0040] Preferably, the biologically active supplement according to the invention contains lecithin and gum arabic as auxiliary substances.

[0041] The present invention in its second embodiment relates to the use of a biologically active supplement according to the invention for the prevention of metabolic syndrome, reducing stress levels in the body, normalizing body mass index, improving overall well-being and increasing energy levels, normalizing biochemical parameters of the blood (glucose, CIC, LDL), reducing the overall inflammatory load of the body, preventing metabolic disorders and cardiovascular diseases, including arterial hypertension, ischemic heart disease, rhythm disorders, cerebrovascular diseases, peripheral arterial diseases, heart failure and diabetes mellitus.

[0042] Experimental part.

[0043] The authors of the present invention conducted an extensive study of mucosal response markers in the blood and found that the composition of magnesium bisglycinate, magnesium citrate, vitamin B6, vitamin B1 helps prevent metabolic syndrome and has synergism. The analysis was carried out according to the following parameters:

[0044] 1. Metabolism of glucose in the body (glucose).

[0045] 2. Normalization of mineral composition - maintaining the functioning of the immune system and metabolism in general.

[0046] 3. Dynamics of regulation of circulating immune complexes (absolute value of CIC) - reduction of the inflammatory load on the body.

[0047] A test was conducted on a biologically active supplement in the form of a capsule containing as active substances a combination consisting of 50 mg of magnesium bisglycinate, 594 mg of magnesium citrate, 2.06 mg of vitamin B1, 2.24 mg of vitamin B6, and containing lecithin and gum arabic as auxiliary substances, with the participation of 11 people (4 men and 7 women). The average age of the participants was 31.8 years (minimum 23, maximum 51 years). The participants used the biologically active supplement according to the instructions 2 capsules twice a day for three weeks.

[0048] Before and after testing, blood analysis data were collected for the following parameters: CIC, glucose, calcium, potassium, sodium, chlorine, magnesium, copper.

[0049] Blood samples were collected in the morning on an empty stomach and analyzed in one authorized laboratory.

[0050] The results were processed using standard functionality for statistical processing in MS Excel.

[0051] Glucose metabolism.

[0052] The study showed that when taking the developed dietary supplement, 8 / 11 respondents had a decrease in blood glucose levels (data in Table No. 1), which indicates a positive correlation between taking the dietary supplement and the level of glucose metabolism and synergism. Table No. 1. Change in glucose concentration after taking the dietary supplement

[0053] Average 5.17 5.04

[0054] St. deviation 0.42 0.32

[0055] A decrease in glucose levels in the body may be evidence of the ability of dietary supplements to prevent metabolic syndrome and diabetes mellitus; a decrease in glucose levels also helps reduce the risk of vascular damage and may be a marker of the body's recovery after stressful situations.

[0056] Mineral composition.

[0057] In addition to improving glucose metabolism, respondents also showed normalization of mineral levels such as sodium, chlorine, magnesium, phosphorus and copper. In 7 / 11 respondents, sodium concentration increased within the normal range, in 5 / 11 respondents, chlorine concentration increased within the normal range, in 7 / 11 respondents, magnesium concentration increased within the normal range, in 6 / 11 respondents, phosphorus concentration increased within the normal range, and in 5 / 11 respondents, copper concentration increased within the normal range (data in Table 2).

[0058] Table No. 2. Change in mineral concentration after taking dietary supplements Magnesium is essential for the proper functioning of muscles and nerves. It helps transmit electrical impulses between nerves and muscles, allowing contraction and relaxation. Magnesium is involved in numerous enzymatic reactions that are involved in the production and utilization of ATP (adenosine triphosphate), a molecule responsible for the storage and release of energy in the body. Magnesium plays a crucial role in bone formation and helps regulate calcium levels in the body. This helps maintain strong and healthy bones. It is involved in the production of proteins that are necessary for growth, repair, and many other physiological processes. Sufficient magnesium levels promote relaxation of blood vessels, helping to regulate blood pressure. Magnesium is necessary for the synthesis, stability, and repair of genetic material (DNA and RNA).It plays an important role in carbohydrate metabolism and helps improve insulin sensitivity, promoting normal blood sugar levels.

[0059] Sodium is responsible for the transmission of impulses of the nervous system and muscle contractions, interacts with other electrolytes and regulates the water-salt balance of the body. Sodium also participates in the normalization of blood pressure and is responsible for controlling heart contractions.

[0060] Chlorine is involved in the functioning of the nervous system, ensures normal transmission of impulses and helps maintain the electrical potential of the cell. Chlorine also plays a role in the functioning of the gastrointestinal tract, maintaining normal stomach acidity, thereby ensuring normal digestion and metabolism of substances entering with food.

[0061] Phosphorus in the form of phosphoric acid residue and its organic compounds participates in the processes of carbohydrate, protein and fat metabolism, is part of phosphoproteins, coenzymes, phospholipids. Phosphoric acid residue and its organic compounds perform structural and metabolic functions in the body. Inorganic phosphate is a component of the mineral structure of bone tissue - oxyapatite. Phospholipids also have a structural function as one of the main building blocks of lipoprotein cell membranes, subcellular organelles (nuclei, mitochondria, lysosomes), as well as membrane structures, in particular myelin.

[0062] Copper is a cofactor in many enzymatic reactions, which determines its importance in many metabolic processes. In addition, copper is necessary for the proper functioning of the immune system, as it helps in the production and activation of immune cells.

[0063] Circulating immune complexes.

[0064] CIC are compounds that consist of specific immunoglobulins, complement components and antigen. They are formed during the reaction of binding antibodies to antigens as a result of the immune response to foreign antigens. The immune system's reaction can be directed both at antigens coming from outside (including viral, bacterial, parasitic infections) and at autoantigens formed during the natural processes of the body's vital activity or as a result of any pathological processes. An increase in the level of CIC in the body is a marker of the development of inflammation, possible infections or allergic reactions, as well as problems with the metabolism of substances.

[0065] When taking the developed dietary supplement, it was shown that the CIC level significantly decreased in respondents after 3 weeks of taking it. The CIC level was reduced in 10 / 10 subjects. The results for subject 47 were considered a statistical outlier and were not included in the processing of the study results (data in Table No. 3).

[0066] Table No. 3. Change in the concentration of CIC after taking dietary supplements

[0067] Thus, the authors of the present invention have demonstrated the innovative activity of the dietary supplement in the prevention of metabolic syndrome and recovery of the body after stressful situations. It is characterized by 1) normalization of glucose metabolism, 2) normalization of the mineral composition of the body, in particular sodium, magnesium, chlorine, copper and phosphorus, which ensure the normal functioning of the nervous system and participate in the processes of metabolism of nutrients, 3) a decrease in the general inflammatory level of the body.

[0068] The examples included in this description do not limit the claimed invention and are provided only for the purpose of illustration and confirmation of the achievement of the expected technical results. These examples are some of the many experimental data obtained by the authors of the invention, which confirm the effectiveness of the means within the scope of the invention.

[0069] LIST OF REFERENCES

[0070] 1. Agnello V., Gabriel A., Tai M. Detection of immune complexes and Journal of Investigative Dermatology. 1976. No. 3 (67).

[0071] 2. Ates M. [et al.]. Dose-Dependent Absorption Profile of Different Magnesium Compounds / / Biological Trace Element Research. 2019. No. 2 (192).

[0072] 3. Barth E., [et al.]. Glucose metabolism and catecholamines. / / Crit Care Med. 2007. No. 35, 9 Suppl. (508)

[0073] 4. Baum D. [et al.]. Metabolic aspects of deep surgical hypothermia in infant. / / Pediatrics. 1968. No. 1 (42).

[0074] 5. Baum D., Porte D. A mechanism for regulation of insulin release in hypoxia. / / The American journal of physiology. 1972. № 3 (222).

[0075] 6. Grant I. [и др.]. Recent life events and diabetes in adults / / Psychosomatic Medicine. 1974. № 2 (36).

[0076] 7. Kim J. А. [и др.]. Reciprocal relationships between insulin resistance and endothelial dysfunction: Molecular and pathophysiological mechanisms / / Circulation. 2006. T. 113. № 15 (904).

[0077] 8. Kondrat’eva E. I., Meniavtseva T. A. Tsirkuliruiushchie immunnye kompleksy i antitela k insulinu pri ozhirenii u detel. / / Pediatriya - Zhumal im G.N. Speranskogo. 1990. № 6.

[0078] 9. Kuo T. [и др.]. Regulation of glucose homeostasis by glucocorticoids И Advances in Experimental Medicine and Biology. 2015. (872).

[0079] 10. Laura Anca P. [и др.]. The Relations Between Immunity, Oxidative Stress and Inflammation Markers, in Childhood Obesity / / Free Radical Biology and Medicine. 2014. (75).

[0080] 11. Lindberg J. S. [и др.]. Magnesium bioavailability from magnesium citrate and magnesium oxide / / Journal of the American College of Nutrition. 1990. № 1 (9). 12. Muhlbauer В. [и др.]. Magnesium-L-aspartate-HCl and magnesium-oxide: bioavailability in healthy volunteers / / European Journal of Clinical Pharmacology. 1991. T. 40. № 4.

[0081] 13. Nydegger U. E., Davis J. S. Soluble immune complexes in human disease / / Critical Reviews in Clinical Laboratory Sciences. 1980. № 2 (12).

[0082] 14. Rawlings A. M. [и др.]. The association of late-life diabetes status and hyperglycemia with incident mild cognitive impairment and dementia: The ARIC study / / Diabetes Care. 2019. № 7 (42).

[0083] 15. Saklayen M. G. The Global Epidemic of the Metabolic Syndrome. / / Current hypertension reports. 2018. № 2 (20). C. 12.

[0084] 16. Sharma К. [и др.]. Stress-Induced Diabetes: A Review / / Cureus. 2022.

[0085] 17. Uberti F. [и др.]. Study of magnesium formulations on intestinal cells to influence myometrium cell relaxation / / Nutrients. 2020. № 2 (12).

[0086] 18. Walker A. F. [и др.]. Mg citrate found more bioavailable than other Mg preparations in a randomised, double-blind study / / Magnesium Research. 2003. № 3 (16).

[0087] 19. Yari Z. [и др.]. New Insight into Diabetes Management: From Glycemic Index to Dietary Insulin Index / / Current Diabetes Reviews. 2019. № 4 (16).

[0088] 20. Dietary Supplements Market Size, Share & Trends Analysis Report By Ingredient , By Type, By End-user, By Distribution Channel, By Form, By Application, By Region, And Segment Forecasts, 2023 - 2030

[0089] 21. National Center for Health Statistics, Division of Health Interview Statistics. Crude and age-adjusted percentage of civilian, noninstitutionalized adults with diagnosed diabetes, United States, 1980-2010. National Center for Chronic Disease Prevention and Health Promotion, Ed. Atlanta, GA, Centers for Disease Control and Prevention, Division of Diabetes Translation, 2012.

[0090] 22. DIETARY SUPPLEMENTS MARKET SIZE & SHARE ANALYSIS - GROWTH TRENDS & FORECASTS (2023 - 2028)

Claims

CLAUSE OF INVENTION 1. A biologically active supplement in the form of a capsule, containing as active substances a combination consisting of magnesium bisglycinate - 45-50 mg, magnesium citrate - 590-600 mg, vitamin B1 - 2-3 mg, vitamin B6 - 2-3 mg, and containing lecithin and gum arabic as auxiliary substances.

2. Use of a biologically active supplement according to item 1 for the prevention of conditions selected from the groups: - metabolic syndrome; - metabolic disorders; - cardiovascular diseases.

3. Use of the biologically active supplement according to paragraph 2 for the prevention of conditions selected from the groups according to paragraph 2, namely: recovery of the body after stressful situations; normalization of glucose metabolism; normalization of the mineral composition of the body, in particular sodium, magnesium, chlorine, copper and phosphorus; reduction of the overall inflammatory level of the body; prevention of arterial hypertension, coronary heart disease, rhythm disturbances, cerebrovascular diseases, peripheral arterial diseases, heart failure and diabetes mellitus; reduction of the stress level in the body; normalization of the body mass index; improvement of overall well-being; increase in energy levels; normalization of biochemical parameters of the blood (glucose, circulating immune complex, LDL); reduction of the overall inflammatory load of the body.

Images