NCT04308980

Safety and Tolerability of Novel Medical Nutrition Products for NAFLD Treatment

Development and Evaluation of the Effectiveness of Complex Therapy of Steatohepatitis of Various Aetiologies Based on Metabolomic Analysis With the Use of Innovative Medical Nutrition Products

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Russian Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To the moment, only limited data are present on the efficacy of changes in diet composition of patients with non-alcoholic fatty liver disease (NAFLD). The national database search in the federal registry of specialized products revealed no registered products for medical nutrition for patients with NAFLD. We developed the composition of specialized food products, produced their experimental batches, and performed laboratory studies of their safety, including tests on toxicology and microbiology (which revealed no concerns). Organoleptic studies of the products showed acceptable results. The aim of the present study is to assess safety and tolerability of newly developed specialized products for medical nutrition of patients with non-alcoholic fatty liver diseases in a prospective randomized placebo-controlled trial.

Detailed description

Development of specialized medical products is actual due to the high prevalence of non-alcoholic fatty liver disease (NAFLD), which accounts for 20-30% of the world's population, while non-alcoholic steatohepatitis (NASH) accounts for about 20% of all cases of NAFLD and affects all age groups, including children. Currently, there are no generally accepted and efficient methods to treat the disease. Recommended measures include changes in lifestyle, i.e., weight loss and dietary modifications together with increased physical activity. Pragmatic approaches combining dietary restriction and a progressive increase in aerobic exercise / resistance training are preferable and should be individually tailored. Only general principles of diet modification are strongly recommended, though the evidence of their efficacy is far from excellent. According to EASL 2016 guidelines on NAFLD, there is a need for energy restriction, exclusion of NAFLD-promoting components (processed food, and food and beverages high in added fructose; the macronutrient composition should be adjusted according to the Mediterranean diet) and avoidance of excessive alcohol intake. Only limited data are available on the change of diet composition, including the intake of products with low glycaemic index, containing larger amounts of components with known antioxidant capacity (including vitamins and minerals) and dietary fibre. Still, the use of mentioned components is promising in the regard of their potential to trigger metabolic changes, decrease insulin resistance, inflammatory processes in the liver tissue and excessive lipid accumulation in the liver in patients with NAFLD. The database search in the federal registry of specialized products revealed no specialized products for medical nutrition for patients with NAFLD. Despite some similarities in the pathogenesis of the diseases, specialized medical products for patients with diabetes mellitus are not optimal for patients with fatty liver disease. Based on the published data, medical and biological requirements for specialized product of medical nutrition were formulated. According to them, at an earlier stage of the present work we developed the composition of specialized food products, produced their experimental batches, and performed laboratory studies of their safety, including tests on toxicology and microbiology (which revealed no concerns). Organoleptic studies of the products showed acceptable results. The aim of the present study is to assess safety and tolerability of newly developed specialized products for medical nutrition of patients with non-alcoholic fatty liver diseases in a prospective randomized placebo-controlled trial.

Conditions

• NAFLD
• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Specialized product for medical nutrition (SPP-1)	Patients randomly allocated to this group will use specialized product for medical nutrition (SPP-1). This product contains: soy protein, whey protein concentrate, microcapsulated rapeseed oil, maltodextrin, inulin, Polydextrose, soy lecithin, potassium citrate, magnesium lactate, ω-3 PUFA (docosahexaenoic acid), sweetener mixture (stevia extract, erythritol), natural flavor "Yogurt-vanilla", calcium carbonate, betaine hydrochloride, natural flavor "raspberry", vitamin premix (vitamins a, e, C, D3, B1, B2, B6, B12, PP, folic acid, Pantothenic acid, K1, Biotin), beet juice concentrate, carrageenan, mineral premix (iron, zinc, copper, manganese, iodine, selenium, molybdenum, chromium), alpha-lipoic acid. The product is packed in approved by sanitary rules bags by 30 g. The instant drink obtained by the mixture of the bag content with warm (30-60C) water should be used immediately after being prepared. The daily dose is 1 pack TID
BEHAVIORAL	individualized diet	All the patients enrolled to the study will be provided with recommendations on diet. Individualized requirements will be calculated based on the results of indirect calorimetry (resting energy expenditures) and measurements of urea in daily urine

Timeline

• Start date: 2020-03-20
• Primary completion: 2021-12-01
• Completion: 2021-12-31
• First posted: 2020-03-16
• Last updated: 2021-02-03

Locations

1 site across 1 country: Russia