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Safety and Tolerability of Novel Medical Nutrition Products for NAFLD Treatment

NCT04308980 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-02-03

No results posted yet for this study

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.

Conditions

  • NAFLD
  • NASH - Nonalcoholic Steatohepatitis

Interventions

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

Sponsors & Collaborators

  • Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

    collaborator OTHER

  • Russian Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Vasily Isakov, Professor · FRC Nutrition and Biotechnology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-20
Primary Completion
2021-12-01
Completion
2021-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04308980 on ClinicalTrials.gov