[Use of a controlled attenuation parameter for the diagnosis of non-alcoholic fatty liver disease].

AIM: To evaluate the efficacy of vibration-controlled transient elastography (VCTE) with a controlled attenuation parameter (CAP) in a population of patients with non-alcoholic fatty liver disease (NAFLD)and to compare to US and different non-invasive indices. MATERIALS AND METHODS: Single center NAFLD patients' database of 2021-2023 years was retrospectively analysed. Data of VCTE evaluation with CAP (FibroScan 530® and FibroScan 630 Expert®) as well as liver US examination results and values of HSI, FLI, BAAT and NAFLD-LFS were extracted. AUROCs for all methods used were constructed and sensitivity and specificity analysis was performed. RESULTS: The data of 1081 patients were available for analysis (385 with steatosis, 274 with NASH, 422 without NAFLD as a control). Ultrasound examination in the diagnosis of liver steatosis compared to VCTE with CAP showed sensitivity and specificity of 94.6 and 63.7%, respectively. Diagnosis of liver steatosis using indices and scales showed sensitivity and specificity of HSI: 97.9 and 60.1% (AUROC 0.90), FLI: 92.5 and 85.3% (AUROC 0.93), BAAT: 76.6 and 73.5% (AUROC 0.82), NAFLD-LFS: 56.7 and 81.8% (AUROC 0.85). CONCLUSION: The sensitivity of the US of the liver was consistent with previous studies, but the specificity was low. The HSI index had the best indicators of sensitivity and specificity in relation to the diagnosis of liver steatosis. Combination of liver US and HSI can be used in screening of liver steatosis, however, for the complete diagnosis better tools which can simultaneously evaluate liver steatosis and fibrosis should be used.

[Clinical evaluation of the efficacy of innovative spread of a given fatty acid composition enriched by adaptogens].

Adaptogens are a group of substances capable to increase the nonspecific resistance of the organism to a wide range of harmful effects and stress. However, only limited data exist on their use in the composition of foods for special dietary uses. The aim of the study was to evaluate the effect of a diet that included vegetable-fat spread enriched with 5-hydroxytryptophan, L-theanine and γ-aminobutyric acid on memory, general well-being and emotional status of healthy volunteers. Material and methods. The single-center, single-blind randomized prospective trial that enrolled persons without signs of significant organic pathology have been performed. Participants were randomly allocated to receive either 45 g/day standard spread enriched with 5-hydroxytryptophan (0.67%), L-theanine (0.56%) and γ-aminobutyric acid (0.45%) (main group, MG) or 45 g/day standard spread (control group, CG) for 10 days. Beside this, all participants followed a standard diet. Initially, as well as on the 10th day after the start of using the diet, the emotional state was assessed using the HADS anxiety and depression scale and Beck's depression inventory (BDI), general well-being by SAN questionnaire, memory according to the Lurie method; reaction time and attention concentration were assessed using the Krepelin counting test and the Burdon correction test. A 5-point Likert visual-analogue scale was used to assess the palatability (pasting) of the product, the severity of feelings of hunger and satiety at the baseline and on the 10th day of the study. All tests were performed under the supervision of staff. During the study, daily monitoring of the presence of adverse events was performed. Results. There were 70 subjects in MG and 70 in CG. Lurie memory score significantly increased in the MG (59.9±6.7 vs 58.1±7.4 points at the baseline; p=0.001), but not in the CG (58.0±6.9 vs 57.3±7.3 points, p>0.05). According to the SAN questionnaire, significant increase of well-being values (46.9±13.4 vs 44.2±13.5 points; p=0.01) and mood (49.9±12.6 vs 47.4±12.9 points; p=0.01) was found in MG, while in CG there was an increase of the mood category only (54.4±10.8 vs 52.2±12.1, p=0.04). At the end of the study an increase of «Satiety¼ (60.3±22.8 vs 51.5±24.8, p=0.022) and decrease of «Hunger¼ score (24.1±19.8 vs 29.1±19.4, p=0.02) were revealed in CG but not in the CG. No significant change was found by the results of other tests, stool form and its frequency in both groups. Conclusion. Newly developed spread enriched with 5-hydroxytryptophan, L-theanine, γ-aminobutyric acid was well-tolerated, did not affect the feeling of hunger and satiety, and improved memory and well-being parameters.

[Modification of dietary patterns in patients with non-alcoholic steatohepatitis].

AIM: To assess efficacy of dietary patterns modification with the use of specialized food in patients with non-alcoholic steatohepatitis (NASH). MATERIALS AND METHODS: We developed new specialized food (SPP2) based on literature data on the role of dietary patterns in pathogenesis of NASH. It contained -3 PUFAs, soluble dietary fiber, phospholipids, -lipoic acid, coenzyme Q10, L-carnitine, complex of vitamins. Patients with NASH (per EASL guidelines), were invited to participate in the study and were randomly assigned to receive either isocaloric diet (ICD) alone (based on the results of indirect calorimetry Cosmed, Italy) or isocaloric diet with specialized food (2 portions of SPP2 a day), for 14 days. Repeated examinations of body composition with phase angle analysis (InBody, Republic of Korea) and blood chemistry were performed at baseline (BL) and after 14 days (EOT). The patients were advised to follow usual physical activity during the study. Non-parametric statistics was used to compare BL and EOT characteristics in the groups. RESULTS: The groups did not differ by age, proportion of females, and baseline characteristics of body composition. Adherence to the diet was 87.5% in the ICD group and 88.2% in the ICD+SPP group (p=0.65). Compliance with the use of SPP was 100%. In the ICD+SPP group significant reduction of body weight was achieved (117.530.1 kg initially, vs 114.928.8 kg at EOT; p=0.007), whereas in the ICD group it was not statistically significant (106.722.1 kg at BL vs 104.016.8 kg at EOT, respectively; p=0.07). In contrast to the ICD group, in those who received ICD+SPP significant decrease in cholesterol (5.31.3 mmol/L at BL vs 4.61.3 mmol/L at EOT; p=0.003), LDL (3.71.0 mmol/L vs 3.31.0 mmol/L, respectively; p=0.009), alkaline phosphatase (132.699.1 vs 112.087.0 U/L; p=0.04), GGT (54.533.2 vs 37.519.7 U/L; p=0.04), insulin resistance index (6.13.2 vs 3.21.5, respectively; p=0.04) was detected. CONCLUSION: Modification of dietary patterns with the use of a specialized food in combination with low-calorie diet allows achieving significant reduction of weight and improve lipid and carbohydrate metabolism, reduce severity of cholestasis in patients with NASH.

[Efficacy of newly developed food for special dietary use in the diet of patients with non-alcoholic steatohepatitis].

Although diet plays a leading role in treatment of non-alcoholic fatty disease (and, in particular, non-alcoholic steatohepatitis), specialized foods for the treatment of these patients have not yet been developed. The aim of the study was to assess efficacy of the food for special dietary use (FSDU) in patients with non-alcoholic steatohepatitis. Material and methods. New FSDU contained (% of the RDAs): protein - 8%; fat - 7% (including ω-3 PUFA - 40%); soluble dietary fiber - 180%; phospholipids - 25%; alpha-lipoic acid - 33%; betaine - 10%; 12 mineral substances - 13-44%; 13 vitamins - 24-140%. The study (NCT04308980) was approved by local ethics committee and enrolled patients with diagnosis of NASH. Subjects were randomized to the following groups: those received iso-calorie diet (according to resting energy expenditures, by indirect calorimetry) alone (ICD) and iso-calorie diet + FSDU (2 portions per day, 14 days) (ICD + FSDU group). Safety was assessed based on clinical and laboratory data. Repeated measurements (baseline vs those on the 15th day of the study) of body composition assessed by bioelectrical impedance analysis, and blood chemistry were compared. Results. The results of complex examination of 20 subjects (12 in ICD + FSDU and 8 in ICD group) served as a source for the study. Initially, groups did not differ by age, sex, and body mass index (BMI). The product was well tolerated. In contrast to ICD group, those in ICD + FSDU group demonstrated greater decrease of weight: BMI initially (BMI0) (M±σ): 38.7±5.4 kg/m2 vs BMI at the end-point (BMIEOT) 36.7±5.1 kg/m2, p=0.003 in ICD + FSDU group, whereas in the ICD group BMI0=38.9±7.2 vs BMIEOT=38.9±7.3 kg/m2, p=0.08. These results were reached predominantly by a decrease of fat mass: body fat weight (BFW0) 50.2±10.7 vs BFWEOT=48.5±10.8 kg, p=0.002 in ICD + FSDU group, whereas BFW0=48.9±11.4 vs BFWEOT=47.8±11.6 kg, p=0.07 in ICD group. The activity of alanine and aspartate aminotransferase, gamma-glutamil transpeptidase and alkaline phosphatase decreased in ICD + FSDU group (р=<0.05), whereas in ICD group the difference between initial and control assessment was not significant (р=<0.10). Conclusion. The new FSDU is well tolerated by patients with NASH. In combination with iso-calorie diet, it may increase efficacy of weight loss, predominantly by fat.

[Specialized products for dietary correction of the diet of patients with non-alcoholic steatohepatitis].

Non-alcoholic steatohepatitis (NASH) is a widespread disorder associated with a number of metabolic disorders. Lifestyle modification, including diet and physical activity are currently a first-line treatment for the disease. However, there is lack of specialized products (SP) with modified carbohydrate and fat composition, containing biologically active ingredients with proven physiological effects on the liver for this disorder. The aim of the paper is to summarize present knowledge on the biologically active ingredients with proven hepatoprotective effect and to describe the process of the development of two specialized products for clinical use in patients with NASH. Material and methods. Food ingredients containing soy and milk proteins, soluble dietary fiber, mono- and polyunsaturated fatty acids, vitamins, minerals, soy lecithin, L-carnitine, coenzyme Q10, α-lipoic acid, betaine, flavoring and aromatic additives were used in the development of SP formulations. The mass fraction of moisture in the SP was determined by the thermo-gravimetric method on a humidity analyzer, and the water activity was determined by measuring the dew point. The nutritional and energy value of the SP was calculated using data from chemical composition tables and information from manufacturers of food ingredients. Results and discussion. Taking into account the requirements for dietary therapy, the ingredient composition was scientifically justified and the formulations of two SP with a balanced amino acid composition were developed by using a combination of milk whey proteins, casein and soy protein isolate. The fat component included microencapsulated rapeseed oil, that is a source of mono- and polyunsaturated fatty acids (PUFAs) with the addition of ω-3 PUFAs. The carbohydrate composition was modified by eliminating mono- and disaccharides, traditionally used in sweet drinks, and adding maltodextrin in combination with sweeteners (polyols and natural sweeteners). Polydextrose, citrus pectin, inulin, and hydrolyzed guar gum are used as soluble dietary fibers. The SP included essential micronutrients (vitamins, mineral substances) and bioactive substances that have a proven physiological effect (coenzyme Q10, α-lipoic acid, L-carnitine, betaine hydrochloride, phospholipids). Technical documentation was developed and a pilot batch of SP-1 was developed for inclusion in the complex treatment of patients with NASH. Conclusion. The formulations and technology of SP (SP-1, SP-2) for therapeutic nutrition with a given chemical composition, designed to optimize the diet therapy of patients with NASH, have been developed. SP are sources of animal and vegetable proteins, soluble dietary fiber, mono- and polyunsaturated fatty acids, including ω-3 family, vitamins, minerals and trace elements, as well as bioactive substances with antioxidant, hepatoprotective and hypolipidemic effect. The technical documentation was developed and approved, according to which a pilot batch of SP-1 was produced to assess its effectiveness as a part of complex therapy of patients with NASH.

[Food patterns in Russian patients with gastroesophageal reflux disease: the results of pilot comparative study].

AIM: To evaluate nutritional patterns in patients with gastroesophageal reflux disease (GERD) compared to the control group without GERD. MATERIALS AND METHODS: The data of complex examination of patients referred to perform esophageal pH-impedance recording and who gave written informed consent to participate in the study served as a source data. All the participants underwent complex examination, including clinical data (presence of heartburn and acid regurgitation), symptom evaluation (GERD-Q questionnaire), esophagogastroscopy, esophageal pH-impedance recordings and food frequency questionnaire. Diagnosis of GERD was based on GERD-Q score 8, acid exposure time 6%, number of gastroesophageal refluxes 80/day by 24-hrs esophageal pH-impedance recordings. Nutritional patterns were assessed with the use of healthy eating pyramid principles. RESULTS: Overall 165 patients were enrolled and the data of 150 of them (34 with confirmed GERD and 116 of the control group) were available for the final analysis. The patients of the both groups consumed lower compared to the recommended amounts of dairy and higher amounts of meat. Those with GERD consumed larger amounts of fruits (0.910.68 compared to the values of healthy eating pyramid vs 0.520.57 in the control group, p=0.001), and fats (0.690.55 vs 0.490.55, p=0.001). Compared to the controls, patients with GERD consumed lower amounts of vegetables (0.860.46 of the healthy eating pyramid vs 0.940.63 in the control group, р=0.004) and sugars confectionaries (0.380.39 vs 1.930.98, p=0.0001). CONCLUSION: Nutritional patterns of patients with gastroesophageal reflux disease significantly differ compared to the control group. The obtained data may be used for diet modification in patients with arterial hypertension.

[Association of nutritional patterns and arterial hypertension in Russia: does it exist?]

AIM: To evaluate nutritional patterns in patient with arterial hypertension (AH) compared to the control group without elevated blood pressure. MATERIALS AND METHODS: Retrospective search for unique records of the patients aged 1875 y.o. with complete data on usual nutrition with food frequency methods who had no mentions of diabetes mellitus, food intolerance or allergies, and history of major abdominal surgery, as well as signs of secondary reasons of AH. Nutritional patterns were assessed with the use of healthy eating pyramid principles. Ststistical analysis was performed with the use of SPSS 13.0 for Windows software (SPSS Inc., USA). RESULTS: The data of 711 patients were available for the final analysis (595 of them in AH group). Both groups consumed lower compared to the recommended amounts of fruits, dairy and higher amounts of meat. Those with AH consumed larger amounts of vegetables (1.130.74 compared to the values of healthy eating pyramid vs 0.940.63 in the control group; p=0.004), fruits (0.800.66 vs 0.520.57; p=0.001), meat (1.851.05 vs 1.620.91; p=0.002) and fats (0.770.60 vs 0.490.55; p=0.001). On the other hand, there were lower rates of consumption of sugars, and confectionaries in the structure of nutritional patterns in patients with AH compared to the control group: (0.350.44 of the healthy eating pyramid in AH vs 1.930.98, in the control group; p=0.0001). CONCLUSION: Nutritional patterns of patients with arterial hypertension significantly differ compared to the control group. The obtained data may be used for diet modification in patients with arterial hypertension.

[Specialized food products with modified carbohydrate profile for dietary correction of diet of patients with type 2 diabetes].

In recent years, the incidence of diabetes mellitus (DM) in the world is growing steadily. According to the international diabetes Federation (IDF), the number of DM patients in the world in 2015 was 415 million, of them more than 90% - patients with type 2 diabetes. According to forecasts, in 2040 their number will increase to 642 million. Russia ranks fifth among the ten countries with the largest number of the adult population with diabetes. Dietary correction of the diet of patients with type 2 DM is carried out by the inclusion of specialized foods with a modified carbohydrate profile containing ingredients with hypoglycemic action. The purpose of the study - the development of composition and technology of specialized foods and assessment of the possibility of their use in the therapy of patients with type 2 diabetes. Taking into account the medical requirements for diet therapy for type 2 diabetes, composition and technology of two specialized foods in the form of beverage concentrates have been developed. The technology of step-bystep mixing contributed to the uniform distribution of biologically active substances in the mass of the product. The absence of sucrose and digestible polysaccharides in the composition of the developed products was established, the presence of about 1% lactose was due to its content in the protein component. Humidity didn't exceed the standard values for similar products, the values water activity were typical for products with low humidity, which justified the prediction of the microbiological stability of the developed products during storage. The osmolality of the beverages restored in accordance with the method of preparation was 310 and 258 mOsm/kg, which characterized them as isotonic. The products were balanced in amino acid composition, had a high score of essential amino acids due to the introduction of a combination of proteins. The consumption of one serving (30 g) of the product in the form of a drink (200 ml) provided an average daily requirement for essential amino acids by 15-22%, polyunsaturated fatty acids ω-3 - by 10%, ω-6 - by 15%, soluble dietary fibers - by 50-55%, vitamins groups B - by 14-81%, C - by 46%, A, D3, E, K1 - by 17-46%, minerals and trace elements - by 10- 33%. The content of polyphenols was about a half of its adequate level of consumption. The inclusion of specialized foods with a modified carbohydrate profile in the composition of the low-calorie diet lead to the stabilization of postprandial blood glucose levels in patients with type 2 DM.