Clinical Trial

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

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Record status
This record was last updated August 3, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-06.
Trial Details
NCT Number NCT06727279
Lead Sponsor Federal State Budgetary Scientific Institution
Collaborators: EFKO Group, Russian Science Foundation
Conditions Non-alcoholic Fatty Liver Disease NAFLD
Enrollment 50 participants
Start Date 2025-09-15
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-08-03