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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFederal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

About this trial

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

Eligibility criteria

Qualifiers

Willingness to participate;

Confirmed diagnosis of non-alcoholic fatty liver disease based on EASL guidelines.

Disqualifiers

Pregnancy and breastfeeding;

excessive alcohol intake (>20 g/day women and >30 g/day men)

Liver cirrhosis based on liver histology, or liver stiffness measurement (LSM > or =14 kPa by Fibroscan), or APRI > or= 1; or BARD score > or = 2.

Chronic heart failure (I-IV class by NYHA).

Trial design

Treatments tested in this trial

  • Specialized food - Plant-Based Meat Analog
  • standard isocalorie diet

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators