Safety and Tolerability of Novel Medical Nutrition Products for NAFLD Treatment — 052920190055  

NAFLD Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fatty Liver
• NAFLD
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

• NCT number: NCT04308980
• Study type: Interventional
• Source: Russian Academy of Medical Sciences
• Contact: Sergey Morozov, MD, PhD
• Phone: +79104681801
• Email: 84996131091@mail.ru
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 20, 2020
• Completion date: December 31, 2021