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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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Start date: Jan 20, 2025 to Sep 15, 2025
    • Primary completion date: Aug 31, 2025 to Dec 31, 2025
    • Study completion date: Dec 31, 2025 to Feb 28, 2026
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06727279
Lead Sponsor Federal State Budgetary Scientific Institution
Collaborators: EFKO Group, Russian Science Foundation
Conditions
(from sponsor)		 Non-alcoholic Fatty Liver Disease NAFLD
Related terms Non-alcoholic Fatty Liver Disease
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov