Аннотация (русский):
Introduction. Overweight and obesity are leading risk factors for metabolic syndrome (MS). From 20 to 35% of Russian people have this condition, depending on their age. MS is a precursor of cardiovascular disease, diabetes mellitus, diabetic nephropathy, and nonalcoholic steatohepatitis. Specialized foods (SFs) with hypocholesteremic effects are an important component of the diet therapy for MS patients. Creating local SFs to optimize the nutritional status of MS patients and prevent related diseases is a highly promising area of research. The aim of our study was to develop the formulation and technology of SFs and evaluate their effectiveness in MS treatment. Study objects and methods. The objects of the study were food ingredients and SFs. Safety indicators and micronutrient contents were determined by standard methods, whereas nutritional and energy values and amino acid contents were determined by calculation. Results and discussion. Based on medical requirements, we selected functional ingredients and developed a formulation and technology of SFs with an optimized protein, fat, and carbohydrate composition. The formulation included essential micronutrients and biologically active substances with a desirable physiological effect. Clinical trials involved 15 MS patients aged from 27 to 59. For two weeks, they had a low-calorie standard diet with one serving of SFs in the form of a drink instead of a second breakfast. The patients showed a significant improvement in anthropometric indicators. Blood serum tests revealed decreased contents of total cholesterol (by 16.9%), low-density lipoprotein cholesterol (by 15.3%), and triglycerides (by 27.9%). Conclusion. We developed technical specifications and produced a pilot batch of SFs. The trials showed an improvement of lipid metabolism in the MS patients who were taking SFs as part of their diet therapy.

Ключевые слова:
Metabolic syndrome, specialized food, food ingredients, diet therapy

INTRODUCTION
The key factors leading to metabolic syndrome
are increased visceral fat and decreased sensitivity of
peripheral tissues to insulin resulting in compensatory
hyperinsulinemia. These conditions are associated with
disorders of carbohydrate, lipid, and purine metabolism
and arterial hypertension. External contributors to
metabolic syndrome include perinatal development,
nutrition structure, level of physical activity, bad habits,
stress, and others [1, 2]. Genetic factors also play a
role [3]. Almost all metabolic syndrome conditions
are risk factors for cardiovascular diseases, and a
combination of them significantly increases the risk of
their development. Metabolic syndrome is a precursor
of 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 for
metabolic syndrome diagnosis, whereas arterial
hypertension and lipid and carbohydrate metabolism
disorders are additional criteria [5].
In Russia, the first unified criteria for metabolic
syndrome diagnosis were proposed by the Russian
Society of Cardiology (RSC) in 2008 and revised
in 2009. They consider the central (abdominal) type
of obesity to be the main component of metabolic
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syndrome. It is diagnosed at a waist circumference
of over 80 cm for women and over 94 cm for men.
Other metabolic syndrome criteria include high
blood pressure (> 130/95 mm Hg), high triglycerides
(> 1.7 mmol/L), high low-density lipoprotein cholesterol
(> 3.0 mmol/L), low high-density lipoprotein
cholesterol (< 1.0 mmol/L for men; < 1.2 mmol/L
for women), fasting hyperglycaemia (fasting plasma
glucose ≥ 6.1 mmol/L), and impaired glucose tolerance
(plasma glucose 2 h after glucose loading within
7.8–11.1 mmol/L). Patients with central obesity and
two additional criteria are diagnosed with metabolic
syndrome [6].
World statistics for metabolic syndrome depend on
the diagnostic criteria. According to numerous studies
conducted in various countries, metabolic syndrome is
diagnosed in 10–30% of the world adult population. The
metabolic syndrome rate in Russia varies from 20 to
35%, depending on the age group (higher in old age). It
is 2.5 times as common in women as it is in men [7].
Obesity is a leading risk factor for diet-related
diseases, including metabolic syndrome [8]. Over
the past three decades, the world rate of overweight
and obesity has grown by 30% among adults and by
50% among children. By 2025, 40% of men and 50%
of women will be obese [9]. According to the World
Health Organization (WHO), overweight and obesity
lead to type 2 diabetes (44–57% of cases), coronary
heart disease (17–23%), arterial hypertension (17%),
gallstone disease (30%), osteoarthritis (14%), malignant
neoplasms (11%), as well as impaired reproductive
function [10–12].
In Russia, the overweight and obesity rates have
seen a significant growth in the last decade, reaching
60% and 24% among adults and 20% and 5.65% among
children, respectively [13–15].
An integrated approach to metabolic syndrome
treatment involves combining pharmacological agents
and dietetic nutrition. Metabolic syndrome patients
should have a low-calorie diet (1200 kcal for women and
1500 kcal for men). The amounts of fats, carbohydrates,
and proteins should not exceed 25%, 55%, and 20% of
the daily calorie intake, respectively [1, 2, 4]. The main
objective is to lower the risk of developing MS-related
diseases by reducing body weight and increasing tissue
sensitivity to insulin [1].
Metabolic syndrome treatment can be made more
effective by enriching the diet with specialized foods
that have an improved chemical composition. These
foods contain functional ingredients and biologically
active substances that meet modern safety requirements
and have hypolipidemic and hypoglycaemic effects. As
a 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 food
proteins and their beneficial effect on lipid and
carbohydrate metabolism, it is advisable to use
ingredients containing complete, easily digestible
proteins. Milk whey proteins have a balanced amino
acid composition and a high biological value. Compared
to other proteins of animal and plant origin, they have
a higher content of essential amino acids (lysine,
tryptophan, methionine, threonine) and branched-chain
amino acids (valine, leucine and isoleucine), which are
involved in synthesizing muscle protein [16, 17].
Among plant proteins, soy proteins have been
traditionally used in diet correction and prevention of
lipid metabolism disorders and related diseases. They
are isolated from unmodified soy with modern water
extraction technology. This technology preserves
native amino acids and active isoflavones while
removing proteolytic enzyme inhibitors, lectins, urease,
lipoxygenase, and some other compounds. The highly
purified soy isolates contain over 80% protein, are easily
digestible, have a balanced amino acid composition, as
well as hypocholesterolemic and antiatherogenic effects
[18–22].
According to modern scientific literature, the soy
protein hypocholesterolemic effect can be explained
by cholesterol interacting with peptide fractions in the
small intestine. Peptide fractions are formed during
protein digestion in the gastrointestinal tract. This
interaction impairs the micellar solubility of cholesterol
and its absorption, changes the enterohepatic circulation
of bile acids, and thus lowers cholesterol in the liver
and reduces the expression of certain genes of lipid
transport protein mediators [23, 24]. Soy protein has
a high content of glutamine, an amino acid necessary
for glutathione to form. Glutamine protects cells from
damage by free radicals and plays an important role
in the functioning of the immune system [25]. Soy
protein has a limited content of three essential amino
acids: threonine, methionine, and cysteine. Therefore,
it is advisable to use it in combination with milk whey
protein, whose amino acid composition is closest to that
of the “ideal” protein.
Fats are an important supplier of energy in the
diet and a source of sterols, fat-soluble vitamins.
However, excessive consumption of fats contributes
to the development of metabolic syndrome and
related complications. General recommendations
for treating lipid metabolism disorders are to reduce
total cholesterol and saturated fatty acids, while
increasing the proportion of monounsaturated fatty
acids to 10–15% and polyunsaturated fatty acids to
7–9% of the total caloric intake [26–29]. In recent
years, scientists have taken greater interest in the
functional role of monounsaturated fatty acids in the
human body. According to literature, they reduce the
level of atherogenic low density lipoproteins and free
radical oxidation in the body, as well as prevent insulin
resistance [30–32].
Recent studies confirm the importance of omega-3
polyunsaturated fatty acids in the treatment of lipid
metabolism disorders. They also have a beneficial
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effect on the lipid profile of blood and reduce the risk of
developing cardiovascular diseases [33–35].
The carbohydrate profile should be modified by
excluding mono- and disaccharides, which cause a sharp
increase in blood glucose, and by introducing slowly
digested and absorbed carbohydrates, which cause a
gradual increase in postprandial glycemia.
Intensive sweeteners of natural or synthetic origin
and sugar substitutes from the polyol family (xylitol,
sorbitol, maltitol, lactitol, isomaltitol, and erythritol)
are widely used in the food industry to form the
sensory profile characteristic of traditional sweet
products, in particular drinks. Intensive sweeteners
(such as aspartame, saccharin, cyclamates, potassium
acesulfame, sucralose, etc.) are sweeter than sugar
dozens or even hundreds of times. However, they
barely cause any hyperglycemic or insulinemic effect.
Polyols, which are polyhydric alcohols in chemical
structure, have a lower calorie content and sweetness
rate than sucrose (except xylitol with a sweetness
rate of one). Polyols cause a more gradual increase in
postprandial glycemia compared to carbohydrates. They
do not require insulin for absorption, which makes them
suitable for in low-calorie and diabetic foods. Mixing
sweeteners often produces a synergistic effect, which
makes it possible to achieve a sweetness profile close
to sucrose [36, 37]. Excessive intake of sweeteners
can have an adverse effect on the gastrointestinal tract
causing increased bowel sounds, a feeling of bloating or
heaviness, and diarrhea. Therefore, some polyols have
upper permissible levels of daily intake, for example
40 g for xylitol and sorbitol, 45 g for erythritol, and 3 g
for mannitol [38].
Although dietary fiber is not an essential nutrient,
its deficiency is a risk factor for many diseases. Dietary
fiber is known to normalize the motor-evacuation
function of the large intestine and have a prebiotic
effect. Mostly soluble dietary fibers (alginates, pectin,
inulin, β-glucans, gum arabic, some hemicelluloses, and
modified celluloses) have a beneficial effect on lipid and
carbohydrate metabolism. Their hypocholesterolemic
effect is due to their ability to bind and excrete bile
acids and slow down cholesterol absorption in the
small intestine. They also reduce lipids absorption
by increasing their excretion and inhibit cholesterol
synthesis in the liver caused by the formation of shortchain
fatty acids during dietary fiber fermentation
in the large intestine. The hypoglycemic effect of
soluble dietary fibers is caused by slowing gastric
emptying, decreasing availability of starch for digestive
enzymes, and reducing glucose absorption in the small
intestine. As a result, dietary fibers lower postprandial
glycemia [39, 40].
Minerals and vitamins are essential food components
that perform important physiological functions in the
body. There is a problem of micronutrient deficiency
in Russia, which is a risk factor for many nutritionrelated
diseases. Therefore, it is advisable that metabolic
syndrome 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 normal
carbohydrate 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 chromium
with insulin. In particular, it interacts with its dimers,
thus stabilizing the hormone structure or enhancing
its binding to the receptor [44]. The biochemical and
physiological effects of zinc in mammals are determined
by its ability to regulate the chronic inflammatory
status by reducing inflammatory cytokines, reduce the
effects of oxidative stress, and participate in lipid and
carbohydrate metabolism.
Zinc deficiency can be an important risk factor
for type 2 diabetes. Plasma zinc levels are inversely
correlated with glycated hemoglobin levels in diabetes
[45]. Zinc improves glucose metabolism and insulin
sensitivity in diabetics. It plays an important role in
the synthesis, deposition, and secretion of insulin
in pancreatic β-cells. Zinc deficiency has a negative
effect on insulin sensitivity and glucose tolerance [46–
49]. In addition, zinc stimulates glycolysis, inhibits
gluconeogenesis, and is involved in glucose transport in
adipocytes [50]. The metabolic effect of zinc in obesity
is associated with its impact on adipokines, hormones
of adipose tissue (interleukin 6, tumour necrosis factor,
leptin, adiponectin, and others) [51–53]. In particular,
experimental studies show that an adequate level of zinc
in adipose tissue is important for the normal functioning
of adipocytes and leptin synthesis [52]. Complexes
of chromium and zinc with enzymatic hydrolysates
of various food proteins can be effectively used to
obtain new food sources of these trace elements in an
organically bound and highly bioavailable form. Using
such complexes in human nutrition is physiologically
justified [54].
The Russian market of dietetic foods for the
prevention and treatment of nutrition-related diseases
(including metabolic syndrome) is quite limited. This
situation creates a need for studies aimed to develop
new foods that meet modern safety and clinical efficacy
requirements.
Powdered specialized foods are most suitable for a
clinical setting. They can be used to make drinks and
cocktails or added to ready-made cereals and dairy
products (kefir, fermented baked milk, yogurt, and
curdled milk). In addition, dry products are easy to
transport and store, are microbiologically stable, and
have a long shelf life. Their production technology
ensures a wide range of products with various sensory
profiles.
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In connection with the above, our study aimed to
develop and evaluate the clinical efficacy of specialized
foods intended for dietetic treatment of lipid metabolism
disorders in metabolic syndrome patients.
STUDY OBJECTS AND METHODS
The following ingredients were used to develop
specialized 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% dextrose
equivalent (DE) (Syral, France);
– Cegepal 03-C microencapsulated rapeseed oil with
68% 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 (DSM
Nutritional Products Europe Ltd, Switzerland);
– Karnipur Crystalin L-carnitine with 99% main
component (Lonza Ltd, Switzerland);
– EM28304 vitamin premix (DSM Nutritional Products
Europe 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 biochem
B.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, State
Standard 4473-78II);
– Sodium hydroxide (analytic grade, State Standard
4328-77III);
– 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 Products
Europe Ltd., Switzerland).
All the ingredients met safety requirements
established by the Technical Regulations of the Customs
I State Standard 4529-78. Reagents. Zinc chloride. Specifications.
Moscow: Izdatelʹstvo standartov; 1990. 10 p.
II State Standard 4473-78. Reagents. Chromic (III) chloride
hexahydrate. 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 amounts
established in Technical Regulations 029/2012.
The specialized food physicochemical parameters
were determined by standard methods, namely:
– moisture mass fraction: according to State Standard
29246-91VII;
– 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 on
an AquaLab 4TE analyser (Decagon Devices, USA);
– amino acid composition of the milk and soy protein
component: by calculation using the manufacturers’
specifications;
– nutritional and energy values, percentage of average
daily requirement for nutrients and energy: by calculation
using the handbook on chemical composition and
caloric content of food ingredients, taking into account
recommended daily intake of nutrients and energy
according to Technical Regulations 022/2011XI, the
Uniform Sanitary Epidemiological and Hygienic
Requirements for the Goods Subject to Sanitary and
Epidemiological Supervision (Control), as well as
manufacturers’ specifications [55].
RESULTS AND DISCUSSION
Producing specialized foods that meet the
biomedical requirements for metabolic syndrome
patients involves selecting ingredients with a desirable
chemical composition and hypocholesterolemic effect.
IV TR TS 021/2011. Tekhnicheskiy reglament Tamozhennogo soyuza
“O bezopasnosti pishchevoy produktsii” [TR CU 021/2011. Technical
regulations 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 dairy
products safety”]. 2013. 107 p.
VI TR TS 029/2012. Tekhnicheskiy reglament Tamozhennogo soyuza
“Trebovaniya bezopasnosti pishchevykh dobavok, aromatizatorov
i tekhnologicheskikh vspomogatelʹnykh sredstv” [TR CU 029/2012.
Technical regulations of the Customs Union “Safety requirements for
food additives, flavours and processing aids”]. 2012.
VII State Standard 29246-91. Dry canned milk. Methods for
determination of moisture. Moscow: Izdatelstvo standartov; 2001. 6 p.
VIII State Standard R 54635-2011. Functional food products. Method
of vitamin A determination. Moscow: Standartinform; 2013. 12 p.
IX State Standard R 54634-2011. Functional food products. Method
of vitamin E determination. Moscow: Standartinform; 2013. 15 p.
X Regulation 4.1.1672-03. Guidelines on quality and safety control
methods for biologically active food additives. Moscow: Federal
Center for State Sanitary and Epidemiological Supervision of the
Ministry 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.
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Consumer properties of the product (physicochemical
and sensory indicators) and its safety depend primarily
on the ingredients, their technological and sensory
compatibility.
The Russian market offers a wide range of functional
ingredients and biologically active substances that meet
modern safety requirements. In addition to satisfying
human needs for food and energy, they also have a
health-beneficial effect due to their physiological action.
The amount of a functional ingredient in the product
should be physiologically significant. It means that it
should meet the physiological need for it and, at the same
time, ensure adequate consumer properties (appearance,
taste, aroma, texture, etc.).
A 1:1 ratio of soy protein isolate and milk whey
protein was used as a protein component in the
specialized food formulation. Lacprodan 80, a whey
protein concentrate available on the Russian market,
is produced using membrane technology that does
not have a denaturing effect on proteins. Whey
protein concentrate contains about 80% of complete
easily digestible protein with a high amino acid score
compared 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 this
protein source suitable for people with lactase deficiency.
Supro Plus XT 221D IP, an isolated soy protein
used in the specialized food formulation, contains
85% 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 allowed
us to optimize the amino acid composition of the protein
component and ensure a high score of essential amino
acids compared to the FAO/WHO reference scale (1985)
(Fig. 1).
The specialized food fat component is a mixture
of rapeseed oil microcapsules and docosahexaenoic
acid (DHA). A source of monounsaturated and
polyunsaturated fatty acids, rapeseed oil contains
about 60% oleic acid, 20% linoleic (ω-6) acid, and 10%
α-linolenic (ω-3) acid. DHA is a powder with a slight
fishy odor that contains 17–21.5% of DHA isolated from
microalgae.
Maltodextrin, a product of incomplete hydrolysis
of corn starch, was used as a source of carbohydrates.
These are so-called “complex” carbohydrates with a
sweetness rate of 0–0.3 and DE 18.9%.
Maltitol (a polyhydric alcohol obtained by
hydrogenating starch-based maltose) and Stevilia E
(a mixture of erythritol and stevia extract) were used
to form the taste profile of the rehydrated beverage.
Maltitol had a sweetness rate of 0.8, and Stevilia E was
five times as sweet as sugar.
The widespread use of various types of pectin
as a source of soluble dietary fiber is due to the
chemical structure of its molecules. Differences in
physicochemical properties (solubility, gelling and
complexing ability) are determined by the degree
of esterification and the molecular weight of pectin
molecules. The ability of pectin to dissolve in water
and form colloidal systems is important for its use in
food production and for its physiological effect on the
human body. The FAO/WHO experts recommend pectin
for treating cardiovascular diseases, hyperlipidemia,
diabetes, impaired glucose tolerance, obesity, and
hypomotor dyskinesia of the colon and the gallbladder
[37]. Knowing that highly esterified pectins have an
increased solubility in water, we used citrus pectin with
a 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 11
Изолейцин
Лейцин
Лизин
Метионин + Цистеин
Фенилаланин + Тирозин
Треонин
Триптофан
Валин
Essential amino acids, g/100 g protein
СПП Значения эталона ФАО/ ВОЗ
0 1 2 3 4 5 6 7 8 9 10 11
Изолейцин
Лейцин
Лизин
Метионин + Цистеин
Фенилаланин + Тирозин
Треонин
Триптофан
Валин
Essential amino acids, g/100 g protein
СПП Specia lized food З н а ч ения эталона ФАО/ ВОЗ
0 1 2 3 4 5 6 7 8 9 10 11
Изолейцин
Лейцин
Лизин
Метионин + Цистеин
Фенилаланин + Тирозин
Треонин
Триптофан
Валин
Essential amino acids, g/100 g protein
СПП ЗFAнаOч/еWнHияO э rтeаfeлrоeнncаe Ф scАalОe/ ВОЗ
Valine
Tryptophan
Threonine
Phenylalanine + Tyrosine
Methionine + Cysteine
Lysine
Leucine
Isoleucine
0 1 2 3 4 5 6 7 8 9 10 11
Изолейцин
Лейцин
Лизин
Метионин + Цистеин
Фенилаланин + Тирозин
Треонин
Триптофан
Валин
Essential amino acids, g/100 g protein
СПП Значения эталона ФАО/ ВОЗ
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L-carnitine (levocarnitine) is a biologically active
substance whose effectiveness is clinically proven.
This compound plays a major role in the transport
of fatty acids into mitochondria. In clinical practice,
L-carnitine is successfully used in treating a wide
range of diseases, such as anorexia, chronic fatigue
syndrome, cardiovascular pathology, hypoglycemia,
male infertility, and kidney disease [57]. The studies
conducted by the Clinic of Nutritional Treatment at the
Federal Research Centre of Nutrition and Biotechnology
demonstrated the effectiveness of L-carnitine in the diet
of patients with metabolic disorders accompanied by
obesity [58]. According to physiological needs for minor
and biologically active food substances, the average
L-carnitine requirement for adults is 300 mg/day. The
maximum daily intake may reach 900 mg/day [38].
To improve the vitamin status of patients, specialized
foods were enriched with vitamins A, D3, E, K1, C, B1,
B2, B6, B12, PP, calcium D-pantothenate, folic acid, and
biotin in the form of a special water-soluble premix.
In view of the importance of minerals in
physiological processes that ensure normal functioning
of the body, we used salts rich in magnesium, potassium,
and calcium, namely lactic magnesium, potassium
citrate, and calcium carbonate. We also used proteinchelate
complexes of zinc and chromium ions with
peptides of soy protein hydrolysate. The preparation of an
enzymatic soy protein hydrolysate is described in [59].
Thus, the specialized food formulation included
the following ingredients based on the requirements
for metabolic syndrome dietary therapy: whey protein
concentrate, soy protein isolate, microencapsulated
rapeseed oil, maltodextrin, docosahexaenoic acid,
maltitol, pectin, potassium citrate, magnesium lactic
acid, calcium carbonate, a mixture of sweeteners
(stevia extract, erythritol), vitamin premix (vitamins
A, E, C, D3, B1, B2, B6, B12, PP, folic acid, pantothenic
acid, K1, biotin), L-carnitine, organic sources of zinc
and chromium, beta-carotene dye, and natural flavoring
agents.
The specialized food technology included the
following main stages: enzymatic hydrolysis of soy
protein isolate, obtaining protein-chelate complexes
of zinc and chromium, preparing a mixture of minor
ingredients (pre-mix), obtaining specialized foods,
packaging, and labelling.
The protein-chelate zinc complex was obtained
by mixing a pre-prepared 10% aqueous solution of
enzymatic soy protein hydrolysate and a 25% aqueous
solution of zinc chloride in the ratio of 10:1, adding a
solution of sodium hydroxide to reach pH 7.0–7.1, and
then thermostating for 60 min at room temperature with
constant stirring. To remove sediment and mechanical
impurities, the resulting solution was microfiltered in
a tangential flow with a pore diameter of under 5.0 μm.
Those zinc ions which were not related to the peptideamino
acid matrix were removed by nanofiltration. The
filtrate was pasteurized at 75°C for 30 s and freeze-dried.
The protein-chelate chromium complex was obtained
by mixing a 10% aqueous solution of enzymatic
hydrolysis of soy protein isolate and a 10% aqueous
solution of chromium chloride in the ratio of 100:1.
The nanofiltration stage was excluded from the process.
The obtained protein-chelate complexes were ground in
a knife mill and sieved through a sieve with a 1.0 mm
mesh diameter.
The protein-chelate complexes were fine powders
with the following characteristics: beige color, 2.3%
moisture, specific smell, bitter-salty taste, and high
solubility in water. Zinc complex had a zinc content
of 46.1 mg/g and chromium complex had a chromium
content of 4.7 mg/g.
The main objective of dry mixing is to achieve
uniform distribution of minor ingredients in the product.
We used the technology of phased mixing, taking into
account the 1:10–2–1:10–3 ratio of the main ingredients
(sources of proteins, fats, and carbohydrates) and micro
additives (macro- and microelements, vitamins, and
biologically active substances).
At the first stage, a premix was obtained using
docosahexaenoic acid, calcium carbonate, flavoring
agents, vitamin premix, beta-carotene, protein-chelate
chromium complexes of zinc and chromium, L-carnitine,
and 10% of the formulated amount of microencapsulated
rapeseed oil for more even distribution. The ingredients
were mixed in a turbulent mixer at 40 rpm for 35 min.
At the second stage, the resulting premix was mixed with
the rest of the ingredients at 40 rpm for 30 min. The fill
factor of the mixing chamber was 0.7. Using a complex
trajectory of mixing under the influence of gravity
with a specified multidirectional spatial movement of
the mixing chamber minimized the negative effect of
centrifugal forces and prevented so-called “dead zones”
and heating of the product. Direct filling batchers were
used to package 30 g portions of the finished product in
film bags.
The above technology allowed us to obtain a
homogeneous powdery mixture with evenly distributed
minor ingredients, which ensured a recommended
intake of all the nutrients with every portion of the
product. 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. This
characteristic ensures the stability of its properties, as
well as of quality and safety indicators throughout its
shelf life.
Powdered specialized foods can be added to readymade
cereals, desserts, and fermented dairy products.
When rehydrated, they can be used as a drink or a
cocktail. For this, the contents of a package (30 g) must
be poured into a glass and stirred vigorously with 100–
150 mL of hot water (60–80°C) until the product is
homogeneous, or beaten in a blender. The amount of
water can vary, depending on the desired consistency.
One serving (30 g) is recommended per day.
26
Vorobyeva V.M. et al. Foods and Raw Materials, 2020, vol. 8, no. 1, pp. 20–29
Table 1 shows the contents of food components
and biologically active substances in 100 g of the
specialized food and its 30 g serving, as well as a
percentage of the average daily requirement for macroand
micronutrients in one serving.
The content of macro- and micronutrients in
one specialized food serving meets the medical
recommendations for metabolic syndrome treatment.
Based on our studies, we developed Technical
Specifications 10.86.10-007-01897222-2018 “Specialized
food for dietetic preventive and dietetic therapeutic
nutrition – an instant drink”. Valetek Prodimpex, a
Russian research and production company produced a
pilot batch of specialized foods. The sanitary-chemical
and microbiological tests confirmed the products’
compliance with the current regulatory requirements
established by Technological Regulations of the
Customs Union 021/2011 and 027/2012XII.
The clinical efficacy of specialized foods was
assessed by the Department of Metabolic Diseases
at the Federal Research Centre of Nutrition and
Biotechnology. The study involved 15 metabolic
syndrome patients aged 27 to 59. For two weeks, they
had a 1500 kcal hypocaloric standard diet with one
specialized food drink instead of a second breakfast.
During the treatment, the patients showed a decrease
in body weight, body mass index, waist volume, and
body fat mass by an average of 3.6, 3.9, 3.9, and 4.4%,
respectively. Their blood serum tests featured a decrease
of 16.9% in total cholesterol, 15.3% in low-density
lipoprotein cholesterol, and 27.9% in triglycerides,
compared to the initial level.
CONCLUSION
Based on the requirements of modern nutritional
science, we developed a formulation of specialized
foods for metabolic syndrome patients, including
ingredients and biologically active substances with
a hypolipidemic effect. Our technology ensures
uniform distribution of minor ingredients and,
therefore, a desirable content of nutrients in each
serving of the product according to medical and
biological requirements. Further, we developed
Technical Specifications 10.86.10-007-01897222-2018
“Specialized food for dietetic preventive and dietetic
therapeutic nutrition – an instant drink”. The clinical
trials of a pilot batch of specialized foods within a
standard hypocaloric diet showed their effectiveness for
metabolic syndrome patients.
CONTRIBUTION
Concept development – A.A. Kochetkova,
V.K. Mazo; data collection and processing, writing
a manuscript – V.M. Vorobyeva, I.S. Vorobyeva,
Kh.Kh. Sharafetdinov, S.N. Zorin; text editing –
A.A. Kochetkova, V.K. Mazo.
CONFLICT OF INTEREST
The authors state that there is no conflict
of interest.

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