INTRODUCTIONThe key factors leading to metabolic syndromeare increased visceral fat and decreased sensitivity ofperipheral tissues to insulin resulting in compensatoryhyperinsulinemia. These conditions are associated withdisorders of carbohydrate, lipid, and purine metabolismand arterial hypertension. External contributors tometabolic syndrome include perinatal development,nutrition structure, level of physical activity, bad habits,stress, and others [1, 2]. Genetic factors also play arole [3]. Almost all metabolic syndrome conditionsare risk factors for cardiovascular diseases, and acombination of them significantly increases the risk oftheir development. Metabolic syndrome is a precursorof socially significant diseases such as type 2 diabetes,diabetic nephropathy, non-alcoholic steatohepatitis,etc. [4].According to the International Diabetes Federation(IDF), abdominal obesity is the key criterion formetabolic syndrome diagnosis, whereas arterialhypertension and lipid and carbohydrate metabolismdisorders are additional criteria [5].In Russia, the first unified criteria for metabolicsyndrome diagnosis were proposed by the RussianSociety of Cardiology (RSC) in 2008 and revisedin 2009. They consider the central (abdominal) typeof obesity to be the main component of metabolic21Vorobyeva V.M. et al. Foods and Raw Materials, 2020, vol. 8, no. 1, pp. 20–29syndrome. It is diagnosed at a waist circumferenceof over 80 cm for women and over 94 cm for men.Other metabolic syndrome criteria include highblood pressure (> 130/95 mm Hg), high triglycerides(> 1.7 mmol/L), high low-density lipoprotein cholesterol(> 3.0 mmol/L), low high-density lipoproteincholesterol (< 1.0 mmol/L for men; < 1.2 mmol/Lfor women), fasting hyperglycaemia (fasting plasmaglucose ≥ 6.1 mmol/L), and impaired glucose tolerance(plasma glucose 2 h after glucose loading within7.8–11.1 mmol/L). Patients with central obesity andtwo additional criteria are diagnosed with metabolicsyndrome [6].World statistics for metabolic syndrome depend onthe diagnostic criteria. According to numerous studiesconducted in various countries, metabolic syndrome isdiagnosed in 10–30% of the world adult population. Themetabolic syndrome rate in Russia varies from 20 to35%, depending on the age group (higher in old age). Itis 2.5 times as common in women as it is in men [7].Obesity is a leading risk factor for diet-relateddiseases, including metabolic syndrome [8]. Overthe past three decades, the world rate of overweightand obesity has grown by 30% among adults and by50% among children. By 2025, 40% of men and 50%of women will be obese [9]. According to the WorldHealth Organization (WHO), overweight and obesitylead to type 2 diabetes (44–57% of cases), coronaryheart disease (17–23%), arterial hypertension (17%),gallstone disease (30%), osteoarthritis (14%), malignantneoplasms (11%), as well as impaired reproductivefunction [10–12].In Russia, the overweight and obesity rates haveseen a significant growth in the last decade, reaching60% and 24% among adults and 20% and 5.65% amongchildren, respectively [13–15].An integrated approach to metabolic syndrometreatment involves combining pharmacological agentsand dietetic nutrition. Metabolic syndrome patientsshould have a low-calorie diet (1200 kcal for women and1500 kcal for men). The amounts of fats, carbohydrates,and proteins should not exceed 25%, 55%, and 20% ofthe daily calorie intake, respectively [1, 2, 4]. The mainobjective is to lower the risk of developing MS-relateddiseases by reducing body weight and increasing tissuesensitivity to insulin [1].Metabolic syndrome treatment can be made moreeffective by enriching the diet with specialized foodsthat have an improved chemical composition. Thesefoods contain functional ingredients and biologicallyactive substances that meet modern safety requirementsand have hypolipidemic and hypoglycaemic effects. Asa result, they supply the patient’s body with nutrients,including essential polyunsaturated fatty acids,vitamins, macro- and microelements.Taking into account the biological role of foodproteins and their beneficial effect on lipid andcarbohydrate metabolism, it is advisable to useingredients containing complete, easily digestibleproteins. Milk whey proteins have a balanced aminoacid composition and a high biological value. Comparedto other proteins of animal and plant origin, they havea higher content of essential amino acids (lysine,tryptophan, methionine, threonine) and branched-chainamino acids (valine, leucine and isoleucine), which areinvolved in synthesizing muscle protein [16, 17].Among plant proteins, soy proteins have beentraditionally used in diet correction and prevention oflipid metabolism disorders and related diseases. Theyare isolated from unmodified soy with modern waterextraction technology. This technology preservesnative amino acids and active isoflavones whileremoving proteolytic enzyme inhibitors, lectins, urease,lipoxygenase, and some other compounds. The highlypurified soy isolates contain over 80% protein, are easilydigestible, have a balanced amino acid composition, aswell as hypocholesterolemic and antiatherogenic effects[18–22].According to modern scientific literature, the soyprotein hypocholesterolemic effect can be explainedby cholesterol interacting with peptide fractions in thesmall intestine. Peptide fractions are formed duringprotein digestion in the gastrointestinal tract. Thisinteraction impairs the micellar solubility of cholesteroland its absorption, changes the enterohepatic circulationof bile acids, and thus lowers cholesterol in the liverand reduces the expression of certain genes of lipidtransport protein mediators [23, 24]. Soy protein hasa high content of glutamine, an amino acid necessaryfor glutathione to form. Glutamine protects cells fromdamage by free radicals and plays an important rolein the functioning of the immune system [25]. Soyprotein has a limited content of three essential aminoacids: threonine, methionine, and cysteine. Therefore,it is advisable to use it in combination with milk wheyprotein, whose amino acid composition is closest to thatof the “ideal” protein.Fats are an important supplier of energy in thediet and a source of sterols, fat-soluble vitamins.However, excessive consumption of fats contributesto the development of metabolic syndrome andrelated complications. General recommendationsfor treating lipid metabolism disorders are to reducetotal cholesterol and saturated fatty acids, whileincreasing the proportion of monounsaturated fattyacids to 10–15% and polyunsaturated fatty acids to7–9% of the total caloric intake [26–29]. In recentyears, scientists have taken greater interest in thefunctional role of monounsaturated fatty acids in thehuman body. According to literature, they reduce thelevel of atherogenic low density lipoproteins and freeradical oxidation in the body, as well as prevent insulinresistance [30–32].Recent studies confirm the importance of omega-3polyunsaturated fatty acids in the treatment of lipidmetabolism disorders. They also have a beneficial22Vorobyeva V.M. et al. Foods and Raw Materials, 2020, vol. 8, no. 1, pp. 20–29effect on the lipid profile of blood and reduce the risk ofdeveloping cardiovascular diseases [33–35].The carbohydrate profile should be modified byexcluding mono- and disaccharides, which cause a sharpincrease in blood glucose, and by introducing slowlydigested and absorbed carbohydrates, which cause agradual increase in postprandial glycemia.Intensive sweeteners of natural or synthetic originand sugar substitutes from the polyol family (xylitol,sorbitol, maltitol, lactitol, isomaltitol, and erythritol)are widely used in the food industry to form thesensory profile characteristic of traditional sweetproducts, in particular drinks. Intensive sweeteners(such as aspartame, saccharin, cyclamates, potassiumacesulfame, sucralose, etc.) are sweeter than sugardozens or even hundreds of times. However, theybarely cause any hyperglycemic or insulinemic effect.Polyols, which are polyhydric alcohols in chemicalstructure, have a lower calorie content and sweetnessrate than sucrose (except xylitol with a sweetnessrate of one). Polyols cause a more gradual increase inpostprandial glycemia compared to carbohydrates. Theydo not require insulin for absorption, which makes themsuitable for in low-calorie and diabetic foods. Mixingsweeteners often produces a synergistic effect, whichmakes it possible to achieve a sweetness profile closeto sucrose [36, 37]. Excessive intake of sweetenerscan have an adverse effect on the gastrointestinal tractcausing increased bowel sounds, a feeling of bloating orheaviness, and diarrhea. Therefore, some polyols haveupper permissible levels of daily intake, for example40 g for xylitol and sorbitol, 45 g for erythritol, and 3 gfor mannitol [38].Although dietary fiber is not an essential nutrient,its deficiency is a risk factor for many diseases. Dietaryfiber is known to normalize the motor-evacuationfunction of the large intestine and have a prebioticeffect. Mostly soluble dietary fibers (alginates, pectin,inulin, β-glucans, gum arabic, some hemicelluloses, andmodified celluloses) have a beneficial effect on lipid andcarbohydrate metabolism. Their hypocholesterolemiceffect is due to their ability to bind and excrete bileacids and slow down cholesterol absorption in thesmall intestine. They also reduce lipids absorptionby increasing their excretion and inhibit cholesterolsynthesis in the liver caused by the formation of shortchainfatty acids during dietary fiber fermentationin the large intestine. The hypoglycemic effect ofsoluble dietary fibers is caused by slowing gastricemptying, decreasing availability of starch for digestiveenzymes, and reducing glucose absorption in the smallintestine. As a result, dietary fibers lower postprandialglycemia [39, 40].Minerals and vitamins are essential food componentsthat perform important physiological functions in thebody. There is a problem of micronutrient deficiencyin Russia, which is a risk factor for many nutritionrelateddiseases. Therefore, it is advisable that metabolicsyndrome patients enrich their diet with vitamins(groups B, C, E, A, D, beta-carotene), minerals(potassium, magnesium, calcium), and trace elements(chromium, zinc) [41, 42].Trivalent chromium (Cr) is vital for normalcarbohydrate metabolism in humans and animals [43].Chromium stimulates glucose delivery into cells,inducing genes of intracellular signalling systems.There is evidence of direct interaction of chromiumwith insulin. In particular, it interacts with its dimers,thus stabilizing the hormone structure or enhancingits binding to the receptor [44]. The biochemical andphysiological effects of zinc in mammals are determinedby its ability to regulate the chronic inflammatorystatus by reducing inflammatory cytokines, reduce theeffects of oxidative stress, and participate in lipid andcarbohydrate metabolism.Zinc deficiency can be an important risk factorfor type 2 diabetes. Plasma zinc levels are inverselycorrelated with glycated hemoglobin levels in diabetes[45]. Zinc improves glucose metabolism and insulinsensitivity in diabetics. It plays an important role inthe synthesis, deposition, and secretion of insulinin pancreatic β-cells. Zinc deficiency has a negativeeffect on insulin sensitivity and glucose tolerance [46–49]. In addition, zinc stimulates glycolysis, inhibitsgluconeogenesis, and is involved in glucose transport inadipocytes [50]. The metabolic effect of zinc in obesityis associated with its impact on adipokines, hormonesof adipose tissue (interleukin 6, tumour necrosis factor,leptin, adiponectin, and others) [51–53]. In particular,experimental studies show that an adequate level of zincin adipose tissue is important for the normal functioningof adipocytes and leptin synthesis [52]. Complexesof chromium and zinc with enzymatic hydrolysatesof various food proteins can be effectively used toobtain new food sources of these trace elements in anorganically bound and highly bioavailable form. Usingsuch complexes in human nutrition is physiologicallyjustified [54].The Russian market of dietetic foods for theprevention and treatment of nutrition-related diseases(including metabolic syndrome) is quite limited. Thissituation creates a need for studies aimed to developnew foods that meet modern safety and clinical efficacyrequirements.Powdered specialized foods are most suitable for aclinical setting. They can be used to make drinks andcocktails or added to ready-made cereals and dairyproducts (kefir, fermented baked milk, yogurt, andcurdled milk). In addition, dry products are easy totransport and store, are microbiologically stable, andhave a long shelf life. Their production technologyensures a wide range of products with various sensoryprofiles.23Vorobyeva V.M. et al. Foods and Raw Materials, 2020, vol. 8, no. 1, pp. 20–29In connection with the above, our study aimed todevelop and evaluate the clinical efficacy of specializedfoods intended for dietetic treatment of lipid metabolismdisorders in metabolic syndrome patients.STUDY OBJECTS AND METHODSThe following ingredients were used to developspecialized foods for metabolic syndrome patients:– Supro Plus 221 D IP soy protein isolate with 80%protein (Solae, USA);– Lacprodan 80 whey protein concentrate with 80%protein (Arla Foods Ingredients SF, Argentina);– MD1925 QS maltodextrin with 18.9% dextroseequivalent (DE) (Syral, France);– Cegepal 03-C microencapsulated rapeseed oil with68% fat (BASF Personal Care and Nutrition GmbH,Germany);– Crystalline maltitol with 99.5% main component(Shandong Lujian Biological Technology Co., LTD,China);– Genu DZ citrus pectin with 58–62% esterification(CP Kelco Germany GmbH, Germany);– Life, DHA S17-P100 docosahexaenoic acid (DSMNutritional Products Europe Ltd, Switzerland);– Karnipur Crystalin L-carnitine with 99% maincomponent (Lonza Ltd, Switzerland);– EM28304 vitamin premix (DSM Nutritional ProductsEurope Ltd, Switzerland): vitamins A, D3, E, K1, C,B1, B2, B6, B12, PP, calcium D-pantothenate, folic acid,biotin, maltodextrin;– 2-aqueous lactic acid magnesium (PURAC biochemB.V., Spain);– Carbonic calcium (Mineraria Sacilese S.P.A, Italy);– Potassium citrate 3-substituted monohydrate(V.A.G. Chemie GmbH, Germany);– Zinc chloride (analytic grade, State Standard 4529-78I);– 6-aqueous chrome chloride (analytic grade, StateStandard 4473-78II);– Sodium hydroxide (analytic grade, State Standard4328-77III);– Apple natural food flavoring (Givaudan Schweiz AG,Switzerland);– Apricot natural food flavoring (Givaudan Schweiz AG,Switzerland);– Stevilia E mixture of sweeteners: erythritol (E968),stevia extract (E960) (TU 9197-002-49929776-13(Aspasvit, Russia); and– Powdered beta-carotene dye (DSM Nutritional ProductsEurope Ltd., Switzerland).All the ingredients met safety requirementsestablished by the Technical Regulations of the CustomsI State Standard 4529-78. Reagents. Zinc chloride. Specifications.Moscow: Izdatelʹstvo standartov; 1990. 10 p.II State Standard 4473-78. Reagents. Chromic (III) chloridehexahydrate. Specifications. Moscow: Izdatelʹstvo standartov;1992. 15 p.III State Standard 4328-77. Reagents. Sodium hydroxide. Specifications.Moscow: Izdatelʹstvo standartov; 2001. 19 p.Union, namely 021/2011IV, 033/2013V, and 029/2012VI.The food additives were used within the amountsestablished in Technical Regulations 029/2012.The specialized food physicochemical parameterswere determined by standard methods, namely:– moisture mass fraction: according to State Standard29246-91VII;– vitamin A: according to State Standard R 54635-2011VIII;– vitamin E: according to State Standard R 54634-2011IX;– vitamins C, B1, B2, B6, minerals (calcium, magnesium,potassium, chromium, zinc), mono- and disaccharides,L-carnitine: according to Regulation 4.1.1672-03X;– water activity: by a mirror-cooled dew point sensor onan AquaLab 4TE analyser (Decagon Devices, USA);– amino acid composition of the milk and soy proteincomponent: by calculation using the manufacturers’specifications;– nutritional and energy values, percentage of averagedaily requirement for nutrients and energy: by calculationusing the handbook on chemical composition andcaloric content of food ingredients, taking into accountrecommended daily intake of nutrients and energyaccording to Technical Regulations 022/2011XI, theUniform Sanitary Epidemiological and HygienicRequirements for the Goods Subject to Sanitary andEpidemiological Supervision (Control), as well asmanufacturers’ specifications [55].RESULTS AND DISCUSSIONProducing specialized foods that meet thebiomedical requirements for metabolic syndromepatients involves selecting ingredients with a desirablechemical composition and hypocholesterolemic effect.IV TR TS 021/2011. Tekhnicheskiy reglament Tamozhennogo soyuza“O bezopasnosti pishchevoy produktsii” [TR CU 021/2011. Technicalregulations of the Customs Union “On food safety”]. 2011.V TR TS 033/2013. Tekhnicheskiy reglament Tamozhennogo soyuza“O bezopasnosti moloka i molochnoy produktsii” [TR CU 033/2013.Technical regulations of the Customs Union “On milk and dairyproducts safety”]. 2013. 107 p.VI TR TS 029/2012. Tekhnicheskiy reglament Tamozhennogo soyuza“Trebovaniya bezopasnosti pishchevykh dobavok, aromatizatorovi tekhnologicheskikh vspomogatelʹnykh sredstv” [TR CU 029/2012.Technical regulations of the Customs Union “Safety requirements forfood additives, flavours and processing aids”]. 2012.VII State Standard 29246-91. Dry canned milk. Methods fordetermination of moisture. Moscow: Izdatelstvo standartov; 2001. 6 p.VIII State Standard R 54635-2011. Functional food products. Methodof vitamin A determination. Moscow: Standartinform; 2013. 12 p.IX State Standard R 54634-2011. Functional food products. Methodof vitamin E determination. Moscow: Standartinform; 2013. 15 p.X Regulation 4.1.1672-03. Guidelines on quality and safety controlmethods for biologically active food additives. Moscow: FederalCenter for State Sanitary and Epidemiological Supervision of theMinistry of Health of Russia; 2004. 240 p.XI TR TS 022/2011. Tekhnicheskiy reglament Tamozhennogo soyuza“Pishchevaya produktsiya v chasti ee markirovki” [TR CU 022/2011.Technical regulations of the Customs Union “Food labelling”].2011. 29 p.24Vorobyeva V.M. et al. Foods and Raw Materials, 2020, vol. 8, no. 1, pp. 20–29Consumer properties of the product (physicochemicaland sensory indicators) and its safety depend primarilyon the ingredients, their technological and sensorycompatibility.The Russian market offers a wide range of functionalingredients and biologically active substances that meetmodern safety requirements. In addition to satisfyinghuman needs for food and energy, they also have ahealth-beneficial effect due to their physiological action.The amount of a functional ingredient in the productshould be physiologically significant. It means that itshould meet the physiological need for it and, at the sametime, ensure adequate consumer properties (appearance,taste, aroma, texture, etc.).A 1:1 ratio of soy protein isolate and milk wheyprotein was used as a protein component in thespecialized food formulation. Lacprodan 80, a wheyprotein concentrate available on the Russian market,is produced using membrane technology that doesnot have a denaturing effect on proteins. Wheyprotein concentrate contains about 80% of completeeasily digestible protein with a high amino acid scorecompared to the FAO/WHO reference scale (1985).Its minerals (mg/100 g) include calcium (365 mg),sodium (246 mg), magnesium (52 mg), and potassium(524 mg) [56]. The low lactose content makes thisprotein source suitable for people with lactase deficiency.Supro Plus XT 221D IP, an isolated soy proteinused in the specialized food formulation, contains85% protein, about 3% fat, and 1% carbohydrates.Its minerals (mg/100 g) include calcium (50 mg),phosphorus (900 mg), magnesium (34 mg), potassium(1300 mg), sodium (780 mg), iron (12 mg), and copper(1.6 mg).This combination of milk and soy proteins allowedus to optimize the amino acid composition of the proteincomponent and ensure a high score of essential aminoacids compared to the FAO/WHO reference scale (1985)(Fig. 1).The specialized food fat component is a mixtureof rapeseed oil microcapsules and docosahexaenoicacid (DHA). A source of monounsaturated andpolyunsaturated fatty acids, rapeseed oil containsabout 60% oleic acid, 20% linoleic (ω-6) acid, and 10%α-linolenic (ω-3) acid. DHA is a powder with a slightfishy odor that contains 17–21.5% of DHA isolated frommicroalgae.Maltodextrin, a product of incomplete hydrolysisof corn starch, was used as a source of carbohydrates.These are so-called “complex” carbohydrates with asweetness rate of 0–0.3 and DE 18.9%.Maltitol (a polyhydric alcohol obtained byhydrogenating starch-based maltose) and Stevilia E(a mixture of erythritol and stevia extract) were usedto form the taste profile of the rehydrated beverage.Maltitol had a sweetness rate of 0.8, and Stevilia E wasfive times as sweet as sugar.The widespread use of various types of pectinas a source of soluble dietary fiber is due to thechemical structure of its molecules. Differences inphysicochemical properties (solubility, gelling andcomplexing ability) are determined by the degreeof esterification and the molecular weight of pectinmolecules. The ability of pectin to dissolve in waterand form colloidal systems is important for its use infood production and for its physiological effect on thehuman body. The FAO/WHO experts recommend pectinfor treating cardiovascular diseases, hyperlipidemia,diabetes, impaired glucose tolerance, obesity, andhypomotor dyskinesia of the colon and the gallbladder[37]. Knowing that highly esterified pectins have anincreased solubility in water, we used citrus pectin witha 58–62% degree of esterification.Figure 1 Essential amino acids in the specialized food protein component (compared to a reference scale)0 1 2 3 4 5 6 7 8 9 10 11ИзолейцинЛейцинЛизинМетионин + ЦистеинФенилаланин + ТирозинТреонинТриптофанВалинEssential amino acids, g/100 g proteinСПП Значения эталона ФАО/ ВОЗ0 1 2 3 4 5 6 7 8 9 10 11ИзолейцинЛейцинЛизинМетионин + ЦистеинФенилаланин + ТирозинТреонинТриптофанВалинEssential amino acids, g/100 g proteinСПП Specia lized food З н а ч ения эталона ФАО/ ВОЗ0 1 2 3 4 5 6 7 8 9 10 11ИзолейцинЛейцинЛизинМетионин + ЦистеинФенилаланин + ТирозинТреонинТриптофанВалинEssential amino acids, g/100 g proteinСПП ЗFAнаOч/еWнHияO э rтeаfeлrоeнncаe Ф scАalОe/ ВОЗValineTryptophanThreoninePhenylalanine + TyrosineMethionine + CysteineLysineLeucineIsoleucine0 1 2 3 4 5 6 7 8 9 10 11ИзолейцинЛейцинЛизинМетионин + ЦистеинФенилаланин + ТирозинТреонинТриптофанВалинEssential amino acids, g/100 g proteinСПП Значения эталона ФАО/ ВОЗ25Vorobyeva V.M. et al. Foods and Raw Materials, 2020, vol. 8, no. 1, pp. 20–29L-carnitine (levocarnitine) is a biologically activesubstance whose effectiveness is clinically proven.This compound plays a major role in the transportof fatty acids into mitochondria. In clinical practice,L-carnitine is successfully used in treating a widerange of diseases, such as anorexia, chronic fatiguesyndrome, cardiovascular pathology, hypoglycemia,male infertility, and kidney disease [57]. The studiesconducted by the Clinic of Nutritional Treatment at theFederal Research Centre of Nutrition and Biotechnologydemonstrated the effectiveness of L-carnitine in the dietof patients with metabolic disorders accompanied byobesity [58]. According to physiological needs for minorand biologically active food substances, the averageL-carnitine requirement for adults is 300 mg/day. Themaximum daily intake may reach 900 mg/day [38].To improve the vitamin status of patients, specializedfoods were enriched with vitamins A, D3, E, K1, C, B1,B2, B6, B12, PP, calcium D-pantothenate, folic acid, andbiotin in the form of a special water-soluble premix.In view of the importance of minerals inphysiological processes that ensure normal functioningof the body, we used salts rich in magnesium, potassium,and calcium, namely lactic magnesium, potassiumcitrate, and calcium carbonate. We also used proteinchelatecomplexes of zinc and chromium ions withpeptides of soy protein hydrolysate. The preparation of anenzymatic soy protein hydrolysate is described in [59].Thus, the specialized food formulation includedthe following ingredients based on the requirementsfor metabolic syndrome dietary therapy: whey proteinconcentrate, soy protein isolate, microencapsulatedrapeseed oil, maltodextrin, docosahexaenoic acid,maltitol, pectin, potassium citrate, magnesium lacticacid, calcium carbonate, a mixture of sweeteners(stevia extract, erythritol), vitamin premix (vitaminsA, E, C, D3, B1, B2, B6, B12, PP, folic acid, pantothenicacid, K1, biotin), L-carnitine, organic sources of zincand chromium, beta-carotene dye, and natural flavoringagents.The specialized food technology included thefollowing main stages: enzymatic hydrolysis of soyprotein isolate, obtaining protein-chelate complexesof zinc and chromium, preparing a mixture of minoringredients (pre-mix), obtaining specialized foods,packaging, and labelling.The protein-chelate zinc complex was obtainedby mixing a pre-prepared 10% aqueous solution ofenzymatic soy protein hydrolysate and a 25% aqueoussolution of zinc chloride in the ratio of 10:1, adding asolution of sodium hydroxide to reach pH 7.0–7.1, andthen thermostating for 60 min at room temperature withconstant stirring. To remove sediment and mechanicalimpurities, the resulting solution was microfiltered ina tangential flow with a pore diameter of under 5.0 μm.Those zinc ions which were not related to the peptideaminoacid matrix were removed by nanofiltration. Thefiltrate was pasteurized at 75°C for 30 s and freeze-dried.The protein-chelate chromium complex was obtainedby mixing a 10% aqueous solution of enzymatichydrolysis of soy protein isolate and a 10% aqueoussolution of chromium chloride in the ratio of 100:1.The nanofiltration stage was excluded from the process.The obtained protein-chelate complexes were ground ina knife mill and sieved through a sieve with a 1.0 mmmesh diameter.The protein-chelate complexes were fine powderswith the following characteristics: beige color, 2.3%moisture, specific smell, bitter-salty taste, and highsolubility in water. Zinc complex had a zinc contentof 46.1 mg/g and chromium complex had a chromiumcontent of 4.7 mg/g.The main objective of dry mixing is to achieveuniform distribution of minor ingredients in the product.We used the technology of phased mixing, taking intoaccount the 1:10–2–1:10–3 ratio of the main ingredients(sources of proteins, fats, and carbohydrates) and microadditives (macro- and microelements, vitamins, andbiologically active substances).At the first stage, a premix was obtained usingdocosahexaenoic acid, calcium carbonate, flavoringagents, vitamin premix, beta-carotene, protein-chelatechromium complexes of zinc and chromium, L-carnitine,and 10% of the formulated amount of microencapsulatedrapeseed oil for more even distribution. The ingredientswere mixed in a turbulent mixer at 40 rpm for 35 min.At the second stage, the resulting premix was mixed withthe rest of the ingredients at 40 rpm for 30 min. The fillfactor of the mixing chamber was 0.7. Using a complextrajectory of mixing under the influence of gravitywith a specified multidirectional spatial movement ofthe mixing chamber minimized the negative effect ofcentrifugal forces and prevented so-called “dead zones”and heating of the product. Direct filling batchers wereused to package 30 g portions of the finished product infilm bags.The above technology allowed us to obtain ahomogeneous powdery mixture with evenly distributedminor ingredients, which ensured a recommendedintake of all the nutrients with every portion of theproduct. With a moisture content of 3.35 ± 0.04%and a water activity indicator (Aw) of 0.2304 ± 0.0009,the specialized food is a low-moisture product. Thischaracteristic ensures the stability of its properties, aswell as of quality and safety indicators throughout itsshelf life.Powdered specialized foods can be added to readymadecereals, desserts, and fermented dairy products.When rehydrated, they can be used as a drink or acocktail. For this, the contents of a package (30 g) mustbe poured into a glass and stirred vigorously with 100–150 mL of hot water (60–80°C) until the product ishomogeneous, or beaten in a blender. The amount ofwater can vary, depending on the desired consistency.One serving (30 g) is recommended per day.26Vorobyeva V.M. et al. Foods and Raw Materials, 2020, vol. 8, no. 1, pp. 20–29Table 1 shows the contents of food componentsand biologically active substances in 100 g of thespecialized food and its 30 g serving, as well as apercentage of the average daily requirement for macroandmicronutrients in one serving.The content of macro- and micronutrients inone specialized food serving meets the medicalrecommendations for metabolic syndrome treatment.Based on our studies, we developed TechnicalSpecifications 10.86.10-007-01897222-2018 “Specializedfood for dietetic preventive and dietetic therapeuticnutrition – an instant drink”. Valetek Prodimpex, aRussian research and production company produced apilot batch of specialized foods. The sanitary-chemicaland microbiological tests confirmed the products’compliance with the current regulatory requirementsestablished by Technological Regulations of theCustoms Union 021/2011 and 027/2012XII.The clinical efficacy of specialized foods wasassessed by the Department of Metabolic Diseasesat the Federal Research Centre of Nutrition andBiotechnology. The study involved 15 metabolicsyndrome patients aged 27 to 59. For two weeks, theyhad a 1500 kcal hypocaloric standard diet with onespecialized food drink instead of a second breakfast.During the treatment, the patients showed a decreasein body weight, body mass index, waist volume, andbody fat mass by an average of 3.6, 3.9, 3.9, and 4.4%,respectively. Their blood serum tests featured a decreaseof 16.9% in total cholesterol, 15.3% in low-densitylipoprotein cholesterol, and 27.9% in triglycerides,compared to the initial level.CONCLUSIONBased on the requirements of modern nutritionalscience, we developed a formulation of specializedfoods for metabolic syndrome patients, includingingredients and biologically active substances witha hypolipidemic effect. Our technology ensuresuniform distribution of minor ingredients and,therefore, a desirable content of nutrients in eachserving of the product according to medical andbiological requirements. Further, we developedTechnical Specifications 10.86.10-007-01897222-2018“Specialized food for dietetic preventive and dietetictherapeutic nutrition – an instant drink”. The clinicaltrials of a pilot batch of specialized foods within astandard hypocaloric diet showed their effectiveness formetabolic syndrome patients.CONTRIBUTIONConcept development – A.A. Kochetkova,V.K. Mazo; data collection and processing, writinga manuscript – V.M. Vorobyeva, I.S. Vorobyeva,Kh.Kh. Sharafetdinov, S.N. Zorin; text editing –A.A. Kochetkova, V.K. Mazo.CONFLICT OF INTERESTThe authors state that there is no conflictof interest.