RU2846592C2 - Biologically active additive - Google Patents

Abstract

FIELD: biotechnology.

SUBSTANCE: invention relates to biologically active additives. Dietary supplement consists of spirulina, L-arginine, coenzyme Q10, vitamin D3 and potassium citrate. Mass ratio of spirulina : L-arginine : coenzyme Q10 : vitamin D3 : potassium citrate is 150–450 : 75–85 : 8–12 : 1.5–2.5 : 15–75, respectively. Invention enables to obtain dietary supplement, which improves blood microcirculation, stimulates production of nitrogen oxide, reduces blood pressure and normalises blood biochemical parameters, promotes vasodilation, improves and maintains metabolic processes, improves antioxidant status in blood, normalises body weight index, improves general health and compensates for deficit of vital macro- and microelements.

EFFECT: dietary supplement is used for prevention of cardiovascular and neurodegenerative diseases, thyroid diseases, symptoms of chronic fatigue, lethargy, dry skin, locomotor diseases and diseases caused by unhealthy diet.

6 cl, 3 dwg, 7 tbl

Description

The invention relates to the field of biologically active additives that improve blood microcirculation, stimulate the production of nitric oxide (NO), reduce blood pressure and normalize biochemical parameters of the blood (triglycerides, LDL, total cholesterol, HDL), promote vasodilation, improve energy metabolism in cells, support metabolic processes, improve antioxidant status in the blood, reduce oxidative stress, normalize body mass index, improve overall well-being and increase energy levels, replenish the deficiency of vital macro- and microelements, and are also used to prevent cardiovascular and neurodegenerative diseases, including hypertension, myocardial infarction, atherosclerosis (cholesterol plaques), thrombosis (blood flow congestion and hypercoagulation), stroke, Alzheimer's disease, thyroid disease caused by iodine deficiency, symptoms of chronic fatigue, lethargy, dry skin, weight gain, diseases of the musculoskeletal system, including osteoporosis, diseases caused by poor nutrition, including consequences/conditions from poor nutrition (low activity of the immune system, low efficiency of the antioxidant system, hypokalemia, hypernatremia, deficiency of fat-soluble vitamins, deficiency of microelements, unsatisfactory lipid profile (predominance of LDL, VLDL over HDL)).

Prior art

A well-known biologically active supplement under the trade name "Spirulina VEL" produced by NPO Ecology of Nutrition (Russia, https://ecopit.ru/prod/spirulina) in the form of tablets, containing the microalgae Spirulina ( Spirulina platensis ), known throughout the world as a natural remedy for strengthening the immune system, an additional source of phycocyanins and beta-carotene. Phycocyanin is a strong natural immunostimulant, it stimulates the main parts of the immune system - bone marrow stem cells, macrophages, T-cells and natural killer cells, the spleen and thymus gland. Dietary supplement Spirulina is used to replenish vitamin and mineral deficiencies, normalize metabolism and reduce cholesterol levels in the blood, increase the body's resistance to infections, stabilize weight, prolong youth. Prevention of atherosclerosis, anemia, liver disease, kidney disease, diabetes, obesity, cardiovascular disease, gastrointestinal disease, infectious diseases Strengthens the immune system. Helps improve the functional state of the immune system and reduce the risk of developing colds and infectious diseases (says that the page is not found).

Also known is a biologically active supplement under the trade name "Spirulina VEL + selenium" produced by NPO Ecology of Nutrition (Russia, https://ecopit.ru/prod/spiralina-vel-selen) in the form of tablets, containing the microalgae Spirulina ( Spirulina platensis ) and distinguished by the additional content of selenopyran - an organic source of selenium. Selenium is a powerful antioxidant, it prevents the process of peroxidation in cell membranes, preventing degenerative changes in the most important cell biomolecules (proteins, lipids, nucleic acids), and thereby slows down the aging process of the body. Selenium increases the formation and activity of such defenders of the immune system as T-lymphocytes, antibodies, macrophages, interferon.

However, there is still a need to create a biologically active supplement that would contain the purest (from the point of view of hygienic and microbiological parameters) spirulina powder with a large amount of phycocyanins, as well as biologically active substances such as L-arginine, coenzyme Q10, vitamin D3 and potassium, which are capable of mutually enhancing the complex effect on the cardiovascular system and overall well-being.

The essence of the invention

In a first aspect, the invention relates to a dietary supplement containing spirulina, L-arginine, coenzyme Q10, vitamin D3 and potassium citrate.

In an embodiment of the invention, the mass ratio of spirulina: L-arginine: coenzyme Q10: vitamin D3: potassium citrate can be (150-450):(75-85):(8-12):(1.5-2.5):(15-75), respectively.

In an embodiment of the invention, the mass ratio of spirulina: L-arginine: coenzyme Q10: vitamin D3: potassium citrate can be 250:81.22:10.2:1.95:70.23, respectively.

In one embodiment of the invention, the biologically active supplement may be in the form of a capsule.

In one embodiment of the invention, the capsule may contain, mg/capsule: spirulina (150-300), L-arginine (75-85), coenzyme Q10 (8-12), vitamin D3 (1.5-2.5), potassium citrate (15-75).

In one embodiment of the invention, the capsule may contain, mg/capsule: spirulina about 250, L-arginine about 81.22, coenzyme Q10 about 10.2, vitamin D3 about 1.95, potassium citrate about 70.23.

In one embodiment of the invention, the capsule may contain, mg/capsule: spirulina 250, L-arginine 81.22, coenzyme Q10 10.2, vitamin D3 1.95, potassium citrate 70.23.

In an embodiment of the invention, spirulina is Arthrospira platensis powder.

Brief description of the drawings

Figure 1 shows experimental data for superoxide dismutase.

Figure 2 shows experimental data for glutathione peroxidase.

Figure 3 shows the experimental data for the lymphocyte population.

Description of the invention

General information about the invention

Spirulina, also known as Spirulina platensis or Arthrospira platensis , is a blue-green alga that grows in highly saline waters. It is characterized by a high protein content (65-70% by dry weight), as well as the presence of essential amino acids, vitamin B12, minerals, photosynthetic pigments of high pharmacological significance such as chlorophylls, phycobilin proteins (blue phycocyanins and red phycoerythrins), and other biologically active substances. The presence of these components is associated with the great interest in A. platensis from the medical, cosmetic, and food supplement communities. In particular, preclinical and clinical studies of A. platensis have been conducted, the results of which have shown that spirulina can effectively combat allergic rhinitis, reduce the amount of low and very low density lipoproteins (LDL and VLDL), support the growth of beneficial intestinal microflora, have antitumor, anti-inflammatory, antihypertensive, antioxidant activity, and reduce endothelial dysfunction (de Freitas Brito A. et al. Supplementation with Spirulina platensis modulates aortic vascular reactivity through nitric oxide and antioxidant, 2019). The source of spirulina can be powder (dried crushed material) or dry / liquid spirulina extracts (aqueous; hydroalcoholic; oily; obtained using organic solvents; obtained by sequential extraction, including different polarity).

Daily intake of A. platensis promotes vascular relaxation in a dose-dependent manner by increasing blood levels of endothelial NO (nitric oxide). This is due to the fact that substances in spirulina, such as phycocyanins, increase the expression of endothelial NO synthase (eNOS) and constitutively increase the bioavailability of NO in the body (Huang ZX et al. Protective effects of polysacchride of Spirulina platensis and Sargassum thunbeergii on vascular of alloxan induced diabetic rats, 2005; Freitas Brito A. et al., 2019; El-Shall NA et al. Potential of Spirulina platensis as a feed supplement for poultry to enhance growth performance and immune modulation, 2023).

The NO molecule is involved in many physiological processes that, in addition to vascular homeostasis, include the immune response, improve cognitive function and metabolism (Pappas G., Wilkinson M. L., Gow A. J. Nitric oxide regulation of cellular metabolism: Adaptive tuning of cellular energy, 2022). It is synthesized from L-arginine, a basic amino acid that is present in all human physiological fluids. NO is synthesized with the help of the enzyme NO synthase in all mammalian cells, including endothelial cells, macrophages, neuronal cells, muscle cells and others. There are three isoforms of NO synthase: neuronal, inducible and endothelial (Wu G. et al. Role ofL-arginine in nitric oxide synthesis and health in humans, 2021). At the cellular level, NO regulates the activity of mitochondria, the cellular energy production stations. In particular, it promotes an increase in the production of ATP, a molecule that plays a key role in energy metabolism, and reduces the consumption of oxygen required for its synthesis (Pappas et al., 2022; Wynne A. G., Affourtit C. Nitrite lowers the oxygen cost of ATP supply in cultured skeletal muscle cells by stimulating the rate of glycolytic ATP synthesis, 2022).

In addition to increasing NO production, phycocyanin also has high antioxidant activity and effectively neutralizes reactive oxygen species (Huang et al., 2005; Freitas Brito A. et al., 2019). This, in turn, helps reduce fatigue during exercise (Gurney T., Spendiff O. Algae supplementation for exercise performance: current perspectives and future directions for spirulina and chlorella, 2022). Thus, when taking spirulina, normal heart rhythm is restored faster and the threshold lactate level decreases (Kalpana K. et al. Impact of spirulina on exercise induced oxidative stress and post exercise recovery heart rate of athletes in comparison to a commercial antioxidant // Food Nutr J. - 2017. - V. 2. - No. 4. - P. 139.). Spirulina also increases the activity of the enzyme superoxide dismutase and the concentration of glutathione peroxidase in the blood - enzymes that protect the body from reactive oxygen species. In addition, the level of oxidative stress markers decreases: malondialdehyde and lactate dehydrogenase (Lu H. K. et al. Preventive effects of Spirulina platensis on skeletal muscle damage under exercise-induced oxidative stress, 2006; Kalafati M. et al. Ergogenic and antioxidant effects of spirulina supplementation in humans, 2010). The data presented indicate the antioxidant properties of spirulina, which increase the body's tolerance to oxidative stress and improve endurance during physical exercise.

The authors of the invention have developed a biologically active supplement, which includes spirulina powder (preferably 250 mg/capsule) in the form of Spirulina Safe® (Robertet, France), obtained by biotechnology. It is a finely dispersed powder from light green to dark green shades of the microalgae Arthrospira platensis , obtained by culturing in a bioreactor and freeze-drying. The unique production technology allows preserving phycocyanins during the cultivation of spirulina in a stable form, guaranteeing a high concentration of not only active phycocyanin, but also protein and other antioxidant pigments, prevents the accumulation of xenobiotics from the environment and maintains microbiological purity due to the cultivation of spirulina in isolated production conditions (there is no contact with the environment during production).

The use of the biologically active supplement according to the invention improves blood microcirculation, stimulates the production of nitric oxide (NO), reduces blood pressure and normalizes biochemical blood parameters (triglycerides, LDL, total cholesterol, HDL). The mutually enhanced (synergistic) action of the active components of the dietary supplement promotes vasodilation, improves energy metabolism in cells, supports metabolic processes, improves the antioxidant status in the blood, reduces oxidative stress, normalizes the body mass index, improves overall well-being and increases energy levels, replenishes the deficiency of vital micro- and microelements. Such active substances are suitable for the prevention of cardiovascular and neurodegenerative diseases, including hypertension, myocardial infarction, atherosclerosis (cholesterol plaques), thrombosis (blood flow congestion and hypercoagulation), stroke, Alzheimer's disease; thyroid diseases caused by iodine deficiency; symptoms of chronic fatigue, lethargy, dry skin, weight gain, diseases of the musculoskeletal system, including osteoporosis; diseases caused by poor nutrition, including consequences/conditions from poor nutrition: low activity of the immune system, low efficiency of the antioxidant system, hypokalemia, hypernatremia, deficiency of fat-soluble vitamins, deficiency of microelements, unsatisfactory lipid profile (predominance of LDL, VLDL over HDL).

Commercially available spirulina is mainly supplied from the Asia-Pacific region. In addition to Robertet Group, spirulina is also produced by JiaHerb (China). Compared to Spirulina Safe®, the concentration of which by dry weight is from 92% to 100%, Jiaherb produces 60% spirulina powder. Standardization is carried out exclusively for protein - there is no standardization for phycocyanin. Swedlight AB (Sweden) also produces spirulina powder without standardization for phycocyanin. Another company - NATURAL INGREDIENTS (France), standardizes spirulina powder for phycocyanin, however, its concentration is lower than in Spirulina Safe® - 12% compared to Spirulina Safe® >15%.

In addition to spirulina, the dietary supplement contains L-arginine (preferably 81.22 mg/capsule), coenzyme Q10 (CoQIO; preferably 10.2 mg/capsule), vitamin D3 (cholecalciferol; preferably 1.95 mg/capsule) and potassium (potassium citrate; preferably 70.23 mg/capsule), which have properties similar to spirulina both individually and in combination with each other. Recommended dosage: preferably 4 capsules per day.

Commercially available spirulina powder can be characterized by purity from 50% to 100%, L-arginine - from 95% to 101%, coenzyme Q10 - from 95% to 101%, vitamin D3 - from 85,000 IU/g to 125,000 IU/g active substance, potassium - from 35% to 40%.

L-arginine is a precursor of NO. In this regard, for the effective operation of NO synthase and NO synthesis, a sufficient amount of extracellular L-arginine is necessary. In the developed dietary supplement, taking L-arginine improves NO production by endothelial cells in people with an increased risk of developing atherothrombosis and people with confirmed atherothrombosis.

Another substance, CoQ10, contributes to the antioxidant effect by directly interacting with free radicals or acts indirectly - it activates (restores) α-tocopherol and ascorbate for their direct work. At the cellular level, CoQ10 is stored in mitochondria, lysosomes, the Golgi apparatus and the plasma membrane. A link has been shown between a decrease in CoQ10 levels and the development of cardiovascular disorders - up to 75% of patients with coronary heart disease are characterized by a lack of CoQ10. Long-term intake of CoQ10, on the contrary, prevents the development of symptoms of heart failure, reduces the number of side effects and fatal cases from cardiovascular disorders.

Vitamin D3 also protects the cardiovascular system - it reduces blood pressure and the activity of the renin-angiotensin system, improves endothelial function, and reduces oxidative stress. In particular, it has been shown that intracellular pathways leading to the activation of endothelial NO synthase are mediated through the vitamin D receptor, to which vitamin D3 binds.

For the three listed components - L-arginine, CoQ10 and vitamin D3, synergistic activity was revealed and proven with respect to increasing the activity of endothelial NO synthase and NO synthesis both in vitro on cell lines of endotheliocytes and cardiomyocytes and in vivo on rat models, which is illustrated in the experimental examples included in this description. The complex also led to a decrease in the activation of the p53 oncogene and the production of reactive oxygen species.

Potassium is a macronutrient that supports the smooth operation of the sodium-potassium pump, due to the functioning of which the normal state of the nervous and cardiovascular systems is ensured. In particular, it has been shown that when taking potassium, blood pressure decreases, which is especially important for people with vascular hypertension. At the same time, the decrease in blood pressure is more pronounced in people with vascular hypertension than in people with normal blood pressure. In the developed dietary supplement, potassium is presented in the form of potassium citrate.

Thus, in a first aspect, the present invention relates to dietary supplements containing a combination of L-arginine, coenzyme Q10, vitamin D3, more particularly a combination of L-arginine, coenzyme Q10, vitamin D3, supplemented with a potassium source, more particularly a combination of L-arginine, coenzyme Q10, vitamin D, supplemented with a potassium source such as potassium citrate, and spirulina powder.

Spirulina powder may be Spirulina platensis powder, such as commercially available Spirulina platensis powder such as Spirulina Safe®.

In an embodiment of the invention, the weight ratio of spirulina powder: L-arginine: coenzyme Q10: vitamin D3: potassium citrate can be (150-450):(75-85):(8-12):(1.5-2.5):(15-75), respectively, more specifically (220-280):(77-83):(9-11):(1.7-2.3):(67-73), respectively. In an embodiment of the invention, the weight ratio of spirulina powder: L-arginine: coenzyme Q10: vitamin D3: potassium citrate can be about 250:about 81.22:about 10.2:about 1.95:about 70.23, respectively, more specifically 250:81.22:10.2:1.95:70.23, respectively.

In an embodiment of the invention, the biologically active supplement may be in the form of a capsule, for example, a gelatin or vegetable capsule.

In one embodiment of the invention, the capsule may contain, mg/capsule: spirulina powder (150-450), L-arginine (75-85), coenzyme Q10 (8-12), vitamin D3 (1.5-2.5), potassium citrate (15-75), more specifically (220-280), (77-83), (9-11), (1.7-2.3), (67-73), respectively, more specifically (240-260), (81-82), (10.0-10.5), (1.9-2.0), (7-71), respectively. In one embodiment of the invention, the capsule may contain, mg/capsule: spirulina powder about 250, L-arginine about 81.22, coenzyme Q10 about 10.2, vitamin D3 about 1.95, potassium citrate about 70.23. More specifically 250 mg, 81.22 mg, 10.2 mg, 1.95 mg, 70.23 mg respectively.

In one embodiment, the invention also relates to biologically active additives that improve blood microcirculation, stimulate the production of nitric oxide (NO), reduce blood pressure and normalize biochemical blood parameters (triglycerides, LDL, total cholesterol, HDL), promote vasodilation, improve energy metabolism in cells, support metabolic processes, improve antioxidant status in the blood, reduce oxidative stress, normalize body mass index, improve overall well-being and increase energy levels, replenish the deficiency of vital macro- and microelements, and are also used to prevent cardiovascular and neurodegenerative diseases, including hypertension, myocardial infarction, atherosclerosis (cholesterol plaques), thrombosis (blood flow congestion and hypercoagulation), stroke, Alzheimer's disease; thyroid diseases caused by iodine deficiency; symptoms of chronic fatigue, lethargy, dry skin, weight gain; diseases of the musculoskeletal system, including osteoporosis; diseases caused by poor nutrition, including consequences/conditions of poor nutrition (low activity of the immune system, low efficiency of the antioxidant system, hypokalemia, hypernatremia, deficiency of fat-soluble vitamins, deficiency of microelements, unsatisfactory lipid profile (predominance of LDL, VLDL over HDL)).

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.

Mucosal barrier

The mucosal barrier separates the body from the environment and antigens coming from the outside. Being on the front line of the body's defense, it is formed by epithelial cells and the substances they secrete. Mucosal barriers are located throughout the gastrointestinal tract, respiratory tract, and genitourinary tract. They are not isolated membranes, but semipermeable membranes that selectively allow substances necessary for the body to pass through. Substances are transported through cells connected by tight junctions. Cells are characterized by polarity, due to which the directed transport of substances is achieved.

Epithelial cells in the mucosal barrier secrete substances that have a protective function for the body. In particular, in the intestine, Paneth cells and goblet cells secrete antimicrobial peptides and mucin, respectively. Mucin lines the intestinal wall, protecting cells from direct interaction with microorganisms and food particles. NO is also one of these substances - it regulates blood flow in the mucosal barrier, prevents leukocyte attachment, inhibits mast cell activation, and stimulates mucin secretion.

In addition to the above functions, due to which the mucosal barrier is maintained, NO also makes a significant contribution to the mucosal immune response, locally formed on the mucous membranes. In particular, when bacteria are recognized by dendritic cells, NO synthase is activated, due to which a large amount of NO is released. This, in turn, stimulates the switch of B-lymphocytes to the synthesis of immunoglobulins of type A (IgA) and the protection of the body from pathogenic microorganisms). The effect of spirulina on the level of IgA in human saliva was studied and it was shown that it increases the synthesis of this type of immunoglobulin, which indicates the role of algae in mucosal immunity.

The present inventors conducted an extensive study of mucosal response markers in the blood and found that a composition of spirulina, L-arginine, CoQ10, vitamin D3 and potassium promotes mucosal immunity and has synergism. The analysis was performed according to the following parameters:

1. Antioxidant protection (superoxide dismutase (SOD) and glutathione peroxidase (GP)) - protection of plasma membranes from oxidation, improvement of the barrier properties of epithelial cells as part of the mucosal barrier;

2. Normalization of mineral composition (magnesium, iron, zinc) - maintaining the functioning of the immune system and metabolism in general;

3. Dynamics of lymphocyte populations (absolute value of lymphocytes, T-lymphocytes, T-helpers, T-cytotoxic cells, B-lymphocytes) - reduction of pathogenic load on the body.

A test of a dietary supplement with spirulina was conducted with the participation of 11 people (3 men and 8 women). The average age of the participants was 34.6 years (minimum 25, maximum 50 years). The participants used the dietary supplement according to the instructions for use, 2 capsules 2 times a day for three weeks.

Before and after testing, blood test data were collected for the following parameters: Iron (μmol/L), Zinc (μg/ml), Magnesium (μmol/L), Superoxide dismutase (U/g Hb), Glutathione peroxidase (U/g Hb), Lymphocytes (cells/ml), T-lymphocytes (cells/ml), T-helpers (cells/ml), T-cytotoxic lymphocytes (cells/ml), B-lymphocytes (cells/ml).

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

The results were processed using the standard functionality for statistical processing of MS Excel, as well as the SPSS Statistica software package.

Antioxidant system

The study showed that when taking the developed dietary supplement, 5/10 and 7/11 respondents experienced an increase in the concentration of SOD and GP, respectively (data in Table No. 1 and Figures 1, 2), which indicates the presence of a positive correlation between taking the dietary supplement and the level of antioxidant protection and synergism.

Previously, scientists Lu et al. studied the effect of spirulina intake on the functioning of the antioxidant system - after physical exercise. The aim of the study was to demonstrate the preventive effect of spirulina on the destruction of muscle tissue, but not on strengthening the mucosal barrier or immunity, in contrast to the present invention (Lu et al, 2010). The authors of the article showed an increase in the content of SOD and GP after three weeks of spirulina intake - from 1324.09 ± 131.13 to 1852.45 ± 203.98 and 29.01 ± 5.18 to 33.86 ± 3.27, respectively; blood sampling was carried out 30 minutes after training. It is worth noting that the study was conducted on athletes, for whom these indicators are generally higher than in people who do not practice regular physical activity. Despite the fact that ordinary people took part in testing the effectiveness of the present invention, when taking the developed dietary supplement, the concentration of GP increased from 74.89±12.23 to 81.31±12.22, which indicates the advantage of Spirulina Safe® over regular spirulina protein and the unique synergistic activity of the components (data in Table No. 1 and Figures 1, 2).

Increased activity of the antioxidant system helps protect cell membranes from oxidation and prevents damage to the integrity of epithelial cells as part of the mucosal barrier. CoQ10 provides additional protection - it is present in the mitochondrial membranes of almost all human tissues and is necessary for the correct functioning of the respiratory chain. It also plays a role in the regeneration of antioxidants such as α-tocopherol and ascorbate, helping to increase the concentration of active antioxidants in the blood.

Mineral composition

In addition to the increase in the work of the antioxidant system, respondents also noted a normalization of the content of such minerals as magnesium, iron and zinc - in 9/11 respondents, the concentration of magnesium increased within the normal range, in 7/11 respondents, the concentration of iron increased within the normal range, in 5/11 respondents, the concentration of zinc increased within the normal range, while in one respondent, the concentration of zinc returned to normal, initially being in the range of elevated values (data in Table No. 2).

Magnesium regulates the immune system by influencing the cells of innate and adaptive immunity. Magnesium deficiency activates phagocytes, granulocytes and epithelial cells, increases cytokine levels, thus promoting inflammation. Low magnesium levels contribute to the pathophysiology of many chronic diseases and increase the reactivity of the response to immunological disorders.

Iron plays an important role in maintaining healthy microbiota and intestinal barrier function. In turn, this contributes to normal intestinal function and maintenance of the mucosal barrier.

The effectiveness of another microelement, zinc, in modulating the immune system is characterized by an improved response to pathogens, a reduction in inflammatory processes, and the elimination of atopic and allergic reactions. Zinc is rapidly metabolized and has a limited storage space in the body. This determines its positive effect on mucosal immunity.

Magnesium and iron are the leading minerals in spirulina (3.7 mg/g and 1.7 mg/g dry weight of spirulina, respectively). Zinc ranks fourth in the mineral composition and is present in the amount of 70 μg/g dry weight of spirulina. Their content in Spirulina Safe® contributed to the normalization of the mineral composition in respondents. In turn, along with increased antioxidant protection, this also contributes to the maintenance of mucosal immunity.

Lymphocyte composition

A large number of innate and adaptive immune cells participate in maintaining the immune system, transmitting signals to each other in the form of molecules that are perceived by receptors on cell membranes. Among T-lymphocytes, CD4+ T-helpers and CD8+ T-cytotoxic cells are distinguished. The T-helper recognizes antigens on the surface of antigen-presenting (APG) cells, which in turn triggers a cascade of immune response. One of the cells with which the T-helper interacts is the cytotoxic T-lymphocyte. It, in turn, destroys cells affected by viruses and bacteria, as well as tumor cells.

The main function of B-lymphocytes is to produce antibodies that are used by the immune system to identify and subsequently eliminate foreign agents and damaged cells in the body. One of the populations of B-lymphocytes are memory plasma cells, which are necessary for the rapid synthesis of antibodies in case of re-infection.

When taking the developed dietary supplement, it was shown that lymphocyte populations, in particular the absolute value of lymphocytes, T-lymphocytes, T-helpers, T-cytotoxic cells and B-lymphocytes, normalized in 10/11, 10/11, 10/11, 8/11, 9/11 respondents, respectively. This indicates a decrease in the pathogenic load, which confirms the strengthening of the mucosal barrier (data in Tables No. 3a, 3b and in Figure 3).

Thus, the authors of the invention demonstrated the innovative activity of the dietary supplement in strengthening the mucosal barrier and mucosal immunity. It is characterized by 1) protection of the plasma membranes of cells from oxidation by enhancing the work of the antioxidant system and, as a result, preventing the violation of the integrity of the barrier, 2) normalization of the mineral composition of the body, in particular the content of magnesium, iron and zinc, which are involved in maintaining the correct operation of both the entire immune system and mucosal immunity in particular, 3) a decrease in the pathogenic load on the body and an indirect increase in mucosal immunity, 4) synergism of the interaction of active substances.

Table No. 4 presents experimental data on the effect of taking dietary supplements on the functioning of the antioxidant system.

Table No. 5 presents experimental data on the effect of taking dietary supplements on macro- and microelement composition.

Table No. 6 presents experimental data on the effect of taking dietary supplements on the lymphocyte composition.

Claims (8)

1. A biologically active supplement consisting of spirulina, L-arginine, coenzyme Q10, vitamin D3 and potassium citrate, where the mass ratio of spirulina: L-arginine: coenzyme Q10: vitamin D3: potassium citrate is 150-450: 75-85: 8-12: 1.5-2.5: 15-75, respectively. 2. A biologically active supplement according to claim 1, characterized in that the mass ratio of spirulina: L-arginine: coenzyme Q10: vitamin D3: potassium citrate is 250: 81.22: 10.2: 1.95: 70.23, respectively. 3. A biologically active supplement according to paragraph 1, characterized in that it is in the form of a capsule. 4. A biologically active supplement according to item 3, characterized in that the capsule contains, mg/capsule: spirulina 150-450 L-arginine 75-85 coenzyme Q10 8-12 Vitamin D3 1.5-2.5 potassium citrate 15-75 5. A biologically active supplement according to item 4, characterized in that the capsule contains, mg/capsule: spirulina 250 L-arginine 81.22 coenzyme Q10 10.20 Vitamin D3 1.95 potassium citrate 70.23 6. A biologically active supplement according to any one of paragraphs. 1-5, characterized in that the spirulina is spirulina powder, preferably Spirulina platensis powder.