Dietary supplement

Abstract

The invention relates to a dietary supplement in capsule form containing, as active ingredients, a combination consisting of 14-20 wt% iron bisglycinate, including 2.5-3.5 wt% elemental iron, 0.3-2 wt% vitamin B6, 15-25 mg / capsule vitamin C, 0.01-0.08 wt% organic iodine derived from 18-26 wt% bladderwrack extract, 0.04-0.5 wt% vitamin B9 and 0.05-0.7 wt% vitamin B12, with the remainder being a filler and a shell.

Description

[0001] BIOLOGICALLY ACTIVE SUPPLEMENT

[0002] The invention relates to the field of biologically active supplements for replenishing iron deficiency, normalizing hemoglobin levels, as well as for reducing oxidative stress and inflammation, and for protection against reactive oxygen species.

[0003] PREVIOUS LEVEL OF TECHNOLOGY

[0004] Iron plays an important role in normal human metabolism. The adult human body contains 3–5 grams of iron, 80% of which is found in hemoglobin in red blood cells, 10–15% in muscle myoglobin protein and other iron-containing proteins and enzymes (Zhang AS, Enns CA. Iron homeostasis: recently identified proteins provide insight into novel control mechanisms, 2009). Normally, only 0.1% of iron circulates in the blood plasma bound to the protein transferrin (Lawen A., Lane DJR. Mammalian iron homeostasis in health and disease: uptake, storage, transport, and molecular mechanisms of action / / Antioxidants & redox signaling, 2013). In cells, iron is stored in the form of a complex protein complex - ferritin (Andrews S. C. The Ferritin-like superfamily: Evolution of the biological iron storeman from a rubrerythrin-like ancestor, 2010). The main places of accumulation of ferritin at the organ level are the liver, red bone marrow (RBM), and spleen (Moll R., Davis B.Iron, vitamin B 12 and folate, 2017).

[0005] Iron is absorbed by specialized intestinal cells called enterocytes in the form of heme iron or iron bound to an inorganic salt, with heme iron being absorbed more efficiently. When iron enters the blood plasma, it is transported bound to transferrin. Transferrin transports it to the red blood cells, where hemoglobin is synthesized in red blood cells. Hemoglobin is incorporated into mature red blood cells. At the end of their life cycle, red blood cells are phagocytized by macrophages, resulting in the iron being released from hemoglobin and stored as ferritin or returned to the blood plasma (Moll and Davis, 2017).

[0006] Iron deficiency leads to long-term reductions in ferritin levels and a lack of available iron in the body. This leads to changes in laboratory test results, particularly hemoglobin concentration, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and other parameters (Vasconcelos AR et al. Iron bisglycinate chelate and polymaltose iron for the treatment of iron deficiency anemia: a pilot randomized trial, 2018).

[0007] Iron deficiency anemia accounts for 50% of all cases of anemia {Stevens GA et al. Global, regional, and national trends in haemoglobin concentration and prevalence of total and severe anaemia in children and pregnant and non-pregnant women for 1995-2011: a systematic analysis of population-representative data, 2013). The World Health Organization has recognized iron deficiency anemia as the most common nutritional deficiency worldwide: 30% of the population suffers from this deficiency. The most common causes are gastrointestinal (GI) bleeding and menstruation in women, as well as insufficient iron intake and absorption. Iron deficiency is also observed in many chronic diseases, in particular heart failure, chronic kidney disease, and inflammatory bowel disease (Kumar A. et al. Iron deficiency anaemia: pathophysiology, assessment, practical management, 2022).

[0008] Iron deficiency can lead to changes in growth and motor skills, behavioral and cognitive development, the effects of which can be observed even several years after correction. (Lozoff B., Wolf A.W., Jimenez E. Iron-deficiency anemia and infant development: effects of extended oral iron therapy, 1996; Roncagliolo M. et al. Evidence of altered central nervous system development in infants with iron deficiency anemia at 6 mo: delayed maturation of auditory brainstem responses, 1998). People with iron deficiency anemia are recommended to take iron to replenish its stores. Returning iron to normal physiological levels improves quality of life, reduces susceptibility to disease, improves the prognosis for chronic diseases, and increases positive pregnancy outcomes (Kumar A. et al., 2022). In turn, pregnant women, as well as growing children, need to consume more iron (Nielsen O. N., Coskun M., Weiss G. Iron replacement therapy: do we need new guidelines? 2016).

[0009] The authors of this invention created a biologically active supplement (BAS) consisting of elemental iron, vitamin B6, vitamin C, organic iodine, vitamin B9 and vitamin B 12.

[0010] 1. Iron bisglycinate.

[0011] Among the possible dietary supplements for replenishing iron stores, ferrous sulfate is the most common. However, many people avoid it due to its gastrointestinal side effects (Vasconcelos AR et al., 2018). Iron bisglycinate (IBG) and iron polymaltose are iron compounds with better bioavailability and a lower incidence of side effects. BZ consists of two glycine molecules chelated to the divalent iron ion by covalent bonds (Jacobs P., Wood L., Bird AR. Better tolerance of iron polymaltose complex compared with ferrous sulfate in the treatment of anemia, 2000; Ashmead SD. The chemistry of ferrous bis-glycinate chelate, 2001; Ortiz R. et al. Efficacy and safety of oral iron (III) polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia: a multicenter, randomized, controlled study, 2011; Yasa B., Agaoglu L., Unuvar E.Efficacy, tolerability, and acceptability of iron hydroxide polymaltose complex versus ferrous sulfate: a randomized trial in pediatric patients with iron deficiency anemia, 2011). It was also shown that BZ intake is more effective in increasing hemoglobin and iron levels than ferrous sulfate (Pineda O., Ashmead H. DW. Effectiveness of treatment of iron-deficiency anemia in infants and young children with ferrous bis-glycinate chelate, 2001; Duque X. et al. Effect of supplementation with ferrous sulfate or iron bis-glycinate chelate on ferritin concentration in Mexican schoolchildren: a randomized controlled trial, 2014). Cell cultures incubated with BZ, both with and without additional components, demonstrated a lower level of inflammatory reactions compared to a dietary supplement containing pure iron. BJ enters the pathways of cellular iron metabolism, while pure iron is “locked” inside the cells (Uberti F. et al.Iron absorption from three commercially available supplements in gastrointestinal cell lines, 2017).

[0012] 2. L-ascorbic acid (vitamin C).

[0013] For better absorption of iron and its correct metabolism, the presence of other substances is necessary, in particular vitamin C (Lane DJR et al. Cellular iron uptake, trafficking and metabolism: Key molecules and mechanisms and their roles in disease, 2015). In addition to iron metabolism, vitamin C is a cofactor of many other metabolic pathways. It can be presented both in the form of L-ascorbic acid and as sodium ascorbate salt. Vitamin C increases the absorption of non-heme iron in the gastrointestinal tract, as well as the uptake of iron at the cellular level and its subsequent metabolism - it stimulates the synthesis and inhibits the destruction of ferritin, and reduces the release of iron from cells. In the human body, vitamin C is not synthesized de novo, therefore, its consumption is especially important for effective iron absorption (Lane DJ R„ Richardson DR The active role of vitamin C in mammalian iron metabolism: much more than just enhanced iron absorption! 2014).

[0014] 3. Cyanocobalamin (vitamin B12) and folate (vitamin B9). As mentioned earlier, iron deficiency anemia is the most common form of anemia; however, there are other causes. One of these is a deficiency of vitamin B12 (cobalamin) and B9 (folate). In particular, a deficiency of vitamin B12 and, less commonly, B9 can lead to megaloblastic anemia, which impairs red blood cell maturation (Moll and Davis, 2017). Supplementing the diet with vitamins B12 and B9, along with iron, can prevent hematopoietic disorders.

[0015] Folic acid (vitamin B9), along with iron and vitamin B12, also plays a key role in erythropoiesis. In a study by Uberti et al., iron adsorption in vitro was compared using several commercially available dietary supplements in an intestinal adsorption model and gastric epithelial cells. Fisioeme®, which contains ferric pyrophosphate, folic acid, and vitamin C, demonstrated superior results compared to Sideral® (iron pyrophosphate encapsulated in a membrane with vitamins C and B12) and pure ferric pyrophosphate powder. In the presence of Fisioeme®, cells retained greater viability and integrity (Uberti et al., 2017). Deficiencies in folic acid, as well as vitamins B6 and B12, can lead to megaloblastic anemia. The probable mechanism for the development of anemia is incorrect DNA synthesis and, as a consequence, disruption of erythropoiesis (Fishman S. M., Christian P. West K. R. The role of vitamins in the prevention and control of anaemia, 2000).

[0016] Other beneficial functions of folic acid include reducing inflammation in the liver and decreasing the risk of developing steatosis, the first stage of fatty liver disease (Sama L. K. et al. Folic acid supplementation attenuates high fat diet-induced hepatic oxidative stress via regulation of NADPH oxidase, 2012; Xia M. F. et al. Serum folic acid levels are associated with the presence and severity of liver steatosis in Chinese adults, 2018). This is due to the ability of folic acid to regulate the transcription of genes responsible for oxidative stress in the liver and the activity of 5' AMP-activated protein kinase (AMPK). In addition, folic acid affects iron transporters in the liver (Nam H. et al. ZIP14 and DMT1 in the liver, pancreas, and heart are differentially regulated by iron deficiency and overload: implications for tissue iron uptake in iron-related disorders, 2013; Sid V. et al.Folic acid supplementation during high-fat diet feeding restores AMPK activation via an AMP-LKB1 -dependent mechanism, 2015).

[0017] Excessive iron accumulation in the liver can lead to liver dysfunction. This, in turn, can lead to fibrosis, cirrhosis, and cancer. Folic acid prevents excess iron accumulation in the liver and kidneys, which in turn can prevent the development of oxidative stress in these organs (Suliburska J., Skrypnik K., Chmurzynska A. Folic acid affects iron status in female rats with deficiency of these micronutrients, 2020).

[0018] However, Vitamin B 12 may be poorly absorbed in the presence of Vitamin C, especially in people with gastrointestinal diseases, since vitamin B 12, with a deficiency of IF (intrinsic factor - a glycoprotein that carries out the transport function of B 12 - converting B 12 into an easily digestible form), switches to passive diffusion mode.

[0019] In the passive diffusion mode, there is a high probability that vitamin C will destroy large amounts of free cyanocobalamin and convert it into an indigestible form before reaching the bloodstream (Frost, DV; Lapidus, M.; Armstrong, K. (1952). Differential Stability of Various Analogs of Cobalamin to Vitamin C. Science, 116(3005), 119–121. doi:10.1126 / science.l 16.3005.119) and Ahmad, Iqbal; Qadeer, Kiran; Zahid, Saima; Sheraz, Muhammad Ali; Ismail, Tehmina; Hussain, Waqar; Ansari, Izhar Ahmad (2014). Effect of Ascorbic Acid on the Degradation of Cyanocobalamin and Hydroxocobalamin in Aqueous Solution: A Kinetic Study. AAPS PharmSciTech, 15(5), 1324-1333. doi:10.1208 / sl2249-014-0160-5).

[0020] 4. Fucus vesiculosus extract.

[0021] Another component of the dietary supplement is an extract of the seaweed Fucus vesiculosus. It is an edible seaweed common in the Atlantic Ocean, on the shores of the Pacific Ocean, Greenland, northern Russia, and the Baltic Sea (Pozharitskaya O. N. et al. Pharmacokinetic and tissue distribution of offucoidan from Fucus vesiculosus after oral administration to rats, 2018). Bladderwrack has been identified as a promising functional food due to its high content of iodine and several other bioactive substances, such as kelp, alginate, and fucoidan (Chater P. I. et al. Inhibitory activity of extracts of Hebridean brown seaweeds on lipase activity, 2016).

[0022] Traditional use of Fucus vesiculosus has been associated with reduced calorie intake and weight loss in adults. The extract is also used to treat goiter, rheumatoid arthritis, asthma, psoriasis, and wound healing (Catarino M. D., Silva A. M. S., Cardoso S. M. Fucaceae: A source of bioactive phlorotannins, 2017; Ventura S. et al. Safety evidence on the administration of Fucus vesiculosus L. (bladderwrack) extract and lamotrigine: Data from pharmacokinetic studies in the rat, 2020). Indeed, the iodine contained in Fucus vesiculosus can stimulate the thyroid gland, which plays an important role in metabolism. In particular, the hormone triiodothyronine (T3) controls energy and metabolic homeostasis, regulates body weight, thermogenesis and lipid metabolism (Witkowska-S^dek E. et al. Thyroid dysfunction in obese and overweight children, 2017).

[0023] Along with iron deficiency, iodine deficiency is one of the most common nutritional deficiencies, affecting an estimated 35^5% of the world's population. It can cause goiter, which affects 2.2 billion people annually (Hatch-McChesney A., Lieberman H. R. Iodine and iodine deficiency: a comprehensive review of a re-emerging issue, 2022). Iodine is highly bioavailable: in healthy adults, >90% of consumed iodine is absorbed in the intestine (Zimmermann M. B. Iodine deficiency, 2009; Hatch-McChesney A., Lieberman H. R. Iodine and iodine deficiency: a comprehensive review of a re-emerging issue, 2022).

[0024] Iodine enhances the effect of iron indirectly. Iodine stimulates the production of thyroid hormones - thyroxine (T4), triiodothyronine (T3). Thyroid hormones affect the synthesis of red blood cells - as a consequence, hemoglobin (Wulf NR, Schmitz J, Choi A, Kapusnik-Uner J. Iodine allergy: Common misperceptions. Am J Health Syst Pharm. 2021 Apr 22;78(9):781-793. doi: 10.1093 / ajhp / zxab033. PMID: 33547463; PMCID: PMC7929401).

[0025] This means that iodine, when used in complexes designed to eliminate iron deficiency and improve the functioning of the circulatory system, can activate a new metabolic pathway that is more likely to achieve the desired result.

[0026] 5. Pyridoxine hydrochloride (vitamin B6).

[0027] Another component of the dietary supplement, vitamin B6, is a water-soluble vitamin found in many foods and dietary supplements. It comes in three forms: pyridoxine, pyridoxal, and pyridoxamine. Vitamin B6 deficiency can be caused by both inadequate intake and ineffective absorption. Insufficient vitamin B6 levels are associated with neurological diseases, such as peripheral neuropathy and depression, as well as disorders such as anemia, dermatitis, glossitis, and a weakened immune system (Muhamad R. et al. The Role of Vitamin B6 in Peripheral Neuropathy: A Systematic Review, 2023). Insufficient vitamin B6 intake also impacts iron metabolism. Insufficient intake of vitamin B6 leads to an increase in the concentration of iron in the liver and heart and, conversely, to a decrease in the concentration of iron in skeletal muscles (Mackraj L, Thirumala G., Gathiram P.Vitamin B6 deficiency alters tissue iron concentrations (Wistar, 2009; Mackraj I. et al. Zinc, copper and iron levels in tissues of the vitamin B6-deficient rat, 1997). However, the combination of the above substances is not obvious in terms of the possibility of implementation and synergism, since a number of opposite reactions of the substances in relation to each other are known.

[0028] Thus, the present invention, in its first embodiment, relates to a dietary supplement containing a fixed combination of active ingredients. The active ingredients include a source of elemental iron, a source of organic iodine, vitamin B9, vitamin B12, vitamin C, and vitamin B6.

[0029] Preferably, the biologically active supplement consists of elemental iron (2.5-3.5% by weight) obtained from iron bisglycinate (14-20% by weight), vitamin B6 (0.3-2% by weight), vitamin C (15-25% by weight), organic iodine (0.01-0.08% by weight) obtained from bladderwrack extract (18-26% by weight), vitamin B9 (0.04-0.5) and vitamin B12 (0.05-0.7), with the rest being filler and shell.

[0030] The recommended dosage is 2 capsules per day.

[0031] In this case, iron bisglycinate can be selected as a source of elemental iron in the biologically active supplement, from 14 to 19% by weight, based on the weight of the biologically active supplement; an extract of bladderwrack algae can be selected as a source of organic iodine, from about 18 to about 25% by weight, based on the weight of the biologically active supplement; folic acid and / or methylfolate can be selected as vitamin B9, from 0.05 to about 0.5% by weight, based on the weight of the biologically active supplement; cyanocobalamin and / or methylcobalamin can be selected as vitamin B 12, from 0.05 to 0.7% by weight, based on the weight of the biologically active supplement.

[0032] Elemental iron may be present in the dietary supplement in any of the following mass%: 2.5, 2.6, 2.7, 2.8, 2.9, 3, 3.1, 3.2, 3.3, 3.4, 3.5.

[0033] Iron bisglycinate can be chosen as a source of elemental iron in the dietary supplement. Iron bisglycinate can be present in the dietary supplement in one of the following % by weight: 14, 14.2, 14.4, 14.6, 14.8, 15, 15.2, 15.4, 15.6, 15.8, 16, 16.2, 16.4, 16.6, 16.8, 17, 17.2, 17.4, 17.6, 17.8, 18, 18.2, 18.4, 18.6, 18.8, 19.

[0034] Organic iodine (elemental iodine) may be present in the composition of the dietary supplement in one of the following mass%: 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08.

[0035] Bladderwrack extract can be selected as a source of organic iodine (elemental iodine) in the dietary supplement. Bladderwrack extract can be present in the dietary supplement in one of the following % by weight: 18, 18.5, 19, 19.5, 20, 20.5, 21, 21.5, 22, 22.5, 23, 23.5, 24, 24.5, 25. Vitamin B6 can be present in the dietary supplement in one of the following % by weight: 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.

[0036] Vitamin C may be present in the dietary supplement in one of the following % by weight: 15, 1.5, 16, 16.5, 17, 17.5, 18, 18.5, 19, 19.5, 20, 20.5, 21, 21.5, 22, 22.5, 23, 23.5, 24, 24.5, 25.

[0037] Vitamin B9 may be present in the dietary supplement in one of the following % by weight: 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5. The source of vitamin B9 may be folic acid and / or methylfolate.

[0038] Vitamin B12 may be present in the dietary supplement in one of the following mass %: 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7. The source of vitamin B12 may be cyanocobalamin and / or methylcobalamin. Cyanocobalamin and / or methylcobalamin may be present in the dietary supplement in any of the following mass %: 0.00002, 0.00005, 0.00008, 0.0001, 0.0003, 0.0005.

[0039] Preferably, the biologically active supplement according to the invention is in the form of a capsule.

[0040] The biologically active supplement (BAS) according to the invention consists of iron bisglycinate (60-80 mg / 1 capsule), including elemental iron (12-16 mg / 1 capsule), vitamin B6 (3-4.2 mg / 1 capsule), vitamin C (68-85 mg / 1 capsule), organic iodine obtained from bladderwrack extract (90-120 μg / 1 capsule), vitamin B9 (170-210 μg / 1 capsule) and vitamin B12 (0.7-1.4 μg / 1 capsule). The recommended dosage is 2 capsules per day.

[0041] In this case, iron bisglycinate from about 60 to about 80 mg can be selected as a source of elemental iron, an extract of bladderwrack seaweed from about 90 to about 120 mg can be selected as a source of organic iodine, folic acid and / or methylfolate from about 170 to about 210 mg can be selected as vitamin B9, and cyanocobalamin and / or methylcobalamin from about 0.7 to 1.4 mcg can be selected as vitamin B12.

[0042] Elemental iron may be present in the dietary supplement in any of the following mass ranges (mg): 12, 12.2, 12.4, 12.6, 12.8, 13, 13.2, 13.4, 13.6, 13.8, 14, 14.2, 14.4, 14.6, 14.8, 15, 15.2, 15.4, 15.6, 15.8, 16.

[0043] Iron bisglycinate can be chosen as a source of elemental iron in dietary supplements. Iron bisglycinate can be present in the dietary supplement in one of the following mass ranges (mg): 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80.

[0044] Organic iodine (elemental iodine) may be present in the dietary supplement in one of the following mass ranges (mcg): 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, HO, 111, 112, IZ, 114, 115, 116, 117, 118, 119, 120.

[0045] Bladderwrack extract can be selected as a source of organic iodine (elemental iodine) in the dietary supplement. Bladderwrack extract can be present in the dietary supplement in one of the following mass ranges (mg): 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 114, 115, 116, 117, 118, 119, 120.

[0046] Vitamin B6 may be present in the dietary supplement in one of the following mass ranges (mg): 3, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4, 4.1, 4.2.

[0047] Vitamin C may be present in the dietary supplement in one of the following mass ranges (mg): 68, 69,70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85.

[0048] Vitamin B9 may be present in the dietary supplement in one of the following mass ranges (mcg): 170, 172, 174, 176, 178, 180, 182, 184, 186, 188, 190, 192, 194, 196, 198, 200, 202, 204, 206, 208, 210.

[0049] Vitamin B12 may be present in the dietary supplement in one of the following mass ranges (mcg): 170, 172, 174, 176, 178, 180, 182, 184, 186, 188, 190, 192, 194, 196, 198, 200, 202, 204, 206, 208, 210. The source of vitamin B12 may be cyanocobalamin and / or methylcobalamin. Cyanocobalamin and / or methylcobalamin may be present in the dietary supplement in one of the following mass ranges (mcg): 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.2, 1.4, 1.6, 1.8, 2, 2.2, 2.4, 2.6, 2.8, 3.

[0050] The ranges are calculated based on one capsule containing the ingredients listed above. Each capsule weighs 420-450 mg.

[0051] The above ranges of active ingredients are determined by the purity of the raw materials, various fillers in the active ingredients, as well as various excipients in the raw materials depending on the selected supplier.

[0052] Preferably, the biologically active supplement according to the invention contains lecithin and gum arabic as auxiliary substances. The present invention in a further embodiment relates to the use of the biologically active supplement according to the invention for the prevention of metabolic syndrome, anemia including latent, erythropenia, reducing the level of stress in the body, normalizing the body mass index, improving overall well-being and increasing energy levels, normalizing biochemical parameters of the blood (glucose, circulating immune complexes, LDL), reducing the overall inflammatory load of the body and improving the antioxidant status, preventing metabolic disorders and cardiovascular and neurological diseases, including atherosclerosis, stroke, dementia, preventing diseases of the endocrine system, chronic iodine deficiency, iron deficiency

[0053] The complex, based on the described components, not only replenished iron stores (Table 1) but also demonstrated innovative activity in activating the antioxidant system. After three weeks of taking the dietary supplement (2 capsules daily), selenium-dependent glutathione peroxidase (GPx) and selenium levels in the blood decreased in 12 / 14 and 8 / 14 respondents, respectively. Hemoglobin levels increased in 10 / 14 respondents, and iron levels increased in 11 / 14 respondents. Hemoglobin levels returned to normal in 4 / 6 respondents from low levels, and iron levels returned to normal in 6 / 9 respondents.

[0054] GP plays a key role in the inactivation of reactive oxygen species (ROS). Excessive ROS damage lipids, proteins, and DNA. This, in turn, is associated with cardiovascular disorders, neurodegenerative diseases, tumor development, diabetes, metabolic syndrome, and accelerated aging (Sharifi-Rad M. et al. Lifestyle, oxidative stress, and antioxidants: Back and forth in the pathophysiology of chronic diseases, 2020). This enzyme reduces hydrogen peroxide to water and molecular oxygen. GP is selenium-dependent—its active site contains selenocysteine, which is necessary for the oxidation-reduction reaction (Zhang Y. et al. Role of selenoproteins in redox regulation of signaling and the antioxidant system: A review, 2020). A decrease in the level of GP and associated selenium indicates activation of the antioxidant system (Dalvi et al.The roles of glutathione, glutathione peroxidase, glutathione reductase and the carbonyl protein in pulmonary and extra pulmonary tuberculosis, 2012; Mohideen K. et al. Depleting levels of endogenous anti-oxidant superoxide dismutase in oral sub-mucous fibrosis: A systematic review and meta-analysis, 2022).

[0055] The market offers a dietary supplement from Pure Micronutrients® - "Iron Plus", which contains iron bisglycinate (25 mg), vitamin B6 (25 mg), vitamin C (200 mg), folic acid (400 mcg) and vitamin B12 (100 mcg)

[0056] (https: / / www.puremicronutrients.com / products / iron-plus). Unlike the dietary supplement claimed in the present invention, "Iron Plus" does not contain iodine. While "Iron Plus" claims to support the immune and cardiovascular systems, as well as eye function, it makes no mention of activating the antioxidant system.

[0057] Biogena produces Junior Milti Бо® 13 Nutrigellets®, which contains vitamin C (20 mg), niacin (10 mg), vitamin E (7 mg), pantothenic acid (6 mg), vitamin B2 (1.1 mg), beta-carotene (1 mg, or 167 mcg of vitamin A), vitamin B1 (0.8 mg), vitamin B6 (0.7 mg), folic acid (200 mcg), vitamin K1 (45 mcg), biotin (25 mcg), vitamin D3 (10 mcg), vitamin B12 (1.5 mcg), iron in the form of iron bisglycinate (3 mg), iodine (90 mcg) (https: / / www.biogena.com / en-GB / products / junior-multi-bo-13.html). This dietary supplement is specially designed for teenagers. The manufacturer emphasizes that iodine supports normal growth, and iron contributes to normal cognitive development. However, the effects do not include any information on the antioxidant system.

[0058] Thus, the claimed biologically active supplement according to the present invention has demonstrated an innovative technical result, previously not described in the literature and not claimed by other manufacturers, including the activation of an antioxidant system that deactivates ROS that are destructive to the body.

[0059] EXAMPLES Example 1.

[0060] A test was conducted on a dietary supplement containing elemental iron (2.5-3.5% by weight) obtained from iron bisglycinate (14-20% by weight), vitamin B6 (0.3-2% by weight), vitamin C (15-25% by weight), organic iodine (0.01-0.08% by weight) obtained from bladderwrack extract (18-26% by weight), vitamin B9 (0.04-0.5) and vitamin B12 (0.05-0.7), filler and shell - the rest, with the participation of 14 people (7 women and 3 men). The auxiliary components used were gum arabic (carrier) at a concentration of 13-18% of the total capsule weight, a complex food additive (lecithin) 4-7% of the total capsule weight.

[0061] All components were mixed and encapsulated prior to testing. The average age of participants was 34.9 years (minimum 23, maximum 54 years). Participants took the dietary supplement according to the instructions: 1 capsule twice daily for three weeks. Blood tests were collected before and after testing for the following parameters: hemoglobin (g / dL), iron (μmol / L), selenium (μg / mL), and glutathione peroxidase (U / g Hb). Blood samples were collected in the morning on an empty stomach and analyzed in a single authorized laboratory. The results were processed using standard statistical analysis tools in MS Excel.

[0062] The results of clinical testing are presented in Tables 1 and 2.

[0063] Table No. 1. The effect of taking a dietary supplement containing a combination of active substances according to the invention on iron levels.

[0064] Fe - iron.

[0065] Table No. 2. The effect of taking a biologically active supplement containing a combination of active substances according to the invention on the antioxidant system.

[0066]

[0067] Se - selenium, GP - glutathione peroxidase.

[0068] Hemoglobin data analysis. An increase in hemoglobin levels was observed in 71% of test participants. Of the 6 individuals with initially low iron levels (5 women and 1 man), 5 (4 women and 1 man) experienced an increase in hemoglobin, of which 4 showed a normalization, and 1 woman showed an increase, but to a level below the lower limit of normal. Iron data analysis. An increase in iron levels was observed in 79% of test participants. Of the 9 individuals with initially below-normal levels (7 women and 2 men), 9 experienced an increase in serum iron levels, of which 6 (5 women and 1 man) showed a normalization, 1 man showed an increase, but to a level below the lower limit of normal, and 2 women showed an increase to a level slightly above the upper limit of normal.

[0069] Glutathione peroxidase data analysis. Decreased glutathione peroxidase levels were observed in 85% of test participants. Of the four subjects with baseline levels above normal (four women), four experienced a decrease in their levels, three of whom returned to normal, and one subject experienced a significant decrease, but to a level slightly above the upper limit of normal. A decrease in glutathione peroxidase levels indicates a reduction in oxidative stress and inflammation.

[0070] The test data confirm the hypothesis that the use of the dietary supplement according to the invention helps to replenish iron deficiency, normalize hemoglobin levels, and also helps to reduce oxidative stress and inflammation.

Claims

CLAUSES OF THE INVENTION 1. A biologically active supplement in the form of a capsule, containing as active substances a combination consisting of a source of elemental iron - 2.5-3.5% by weight, a source of organic iodine - 0.01-0.08% by weight, vitamin B9 - 0.04-0.5% by weight, vitamin B12 - 0.05-0.7%, vitamin C - 15-25%, vitamin B6 - 0.3-2% by weight.

2. A biologically active supplement according to paragraph 1, wherein the source of elemental iron is iron bisglycinate.

3. A biologically active supplement according to paragraph 1, where the source of organic iodine is bladderwrack extract.

4. A biologically active supplement according to claim 1, wherein the source of vitamin B 12 is selected from cyanocobalamin and / or methylcobalamin.

5. A biologically active supplement according to claim 1, wherein the source of vitamin B9 is selected from folic acid and / or methylfolate.

6. A biologically active supplement according to item 1, additionally containing lecithin and gum arabic as auxiliary substances.

7. Use of a biologically active supplement according to paragraph 1 for the prevention of conditions selected from the groups: - iron deficiency, - normalization of hemoglobin levels, - reduction of oxidative stress and inflammation, - protection against reactive oxygen species. The use of a biologically active supplement according to paragraph 7 for the prevention of conditions selected from the groups according to paragraph 7, namely: a biologically active supplement according to the invention for the prevention of metabolic syndrome, anemia including latent, erythropenia, normalization of body mass index, improvement of general well-being and increase in energy levels, reduction of the overall inflammatory load of the body and improvement of antioxidant status, prevention of cardiovascular and neurological diseases, including atherosclerosis, stroke, dementia, prevention of diseases of the endocrine system, chronic iodine deficiency, iron deficiency

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