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Assessment of Tolerability of Specialized Food Products Made Out of Vegetable Protein and Their Influence on Lipid Profile in Patients With Non-alcoholic Fatty Liver Disease

NCT06727279 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-08-03

No results posted yet for this study

Summary

To this single-centre randomized controlled comparative study it is planned to enroll 50 patients with non-alcoholic fatty liver disease. All these subjects will receive standard isocaloric diet for 14 days. Subjects of the main group will receive vegetable protein-and-fat cutlet or schnitzel insted of the same amount of standard (animal meat based) cutlet or schnitzel. Subjects of the control group will receive standard diet, with cutlets or schnitzels made of animal meat. It is planned to make repeated measurements of serum lipid profile and assess general well-being and tolerability of newly developed product compared to regular meal

Conditions

  • Non-alcoholic Fatty Liver Disease NAFLD

Interventions

OTHER

Specialized food - Plant-Based Meat Analog

Experimental group receives specialized food made of plant-based (soy) meat analog. A portion of standard (animal) meat in a daily ration of the enrolled subjects is substituted by plant-based analog.

OTHER

standard isocalorie diet

Isocalorie (based on resting energy expenditures measurements) diet is provided to subjects of the control group with no modification of the protein and fat content

Sponsors & Collaborators

  • Group of companies EFKO

    collaborator UNKNOWN

  • Russian Science Foundation

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Vasily Isakov, MD, PhD, Professor · Federal Research Center of Nutrition&Biotechnology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2025-12-31
Completion
2026-02-28

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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 NCT06727279 on ClinicalTrials.gov