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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

ConditionNon-alcoholic Fatty Liver Disease NAFLD
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Specialized food - Plant-Based Meat Analog

    Other intervention

    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.

  • standard isocalorie diet

    Other intervention

    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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: plant-based meat analogExperimental treatment 1 intervention
Group B: Control - standard iso-calorie dietPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

cholesterol

serum cholesterol change

Time frame
baseline and day 14
2

Low-density lipoproteins

Serum concentrations of low-density lipoproteins change

Time frame
baseline and day 14
3

High-density lipoproteins

Serum concentration of HDLP change

Time frame
baseline and day 14
4

triglycerides

Serum concentration of triglycerides change

Time frame
baseline and day 14

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Group of companies EFKO

Collaborator

Russian Science Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: