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NCT Number: NCT06727279

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

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

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Key information

Conditions

Non-alcoholic Fatty Liver Disease NAFLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willingness to participate;
  • Confirmed diagnosis of non-alcoholic fatty liver disease based on EASL guidelines.

Exclusion criteria

  • 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).
  • Past bariatric surgery.
  • Clinically relevant acute cardiovascular event within 6 months prior to screening.
  • Uncontrolled arterial hypertension despite optimal anti-hypertensive therapy.
  • Diabetes mellitus type 1.
  • Serum glycated hemoglobin [HbA1c] concentrations >9.0%.
  • Hypersensitivity to the studied product or any of its components.
  • The intake of any medications that may affect the absorption, distribution, metabolism or excretion of investigational products or may lead to the induction or inhibition of microsomal enzymes (for example, indomethacin) - from the moment of randomization to the end of treatment.
  • Any medical conditions that may significantly affect life expectancy, including known cancers;
  • Any clinically significant immunological, endocrine, haematological, gastrointestinal, neurological or psychiatric diseases;
  • Mental instability or incapacity, which may impact the ability to give informed consent, take part in the study, or affect the ability to comply with study protocol requirements.
  • Positive test for to human immunodeficiency virus antibodies .
  • Aspartate aminotransferase (AST) and/or ALT >10 x upper normal limits.
  • conjugated bilirubin > 26 mcmol/l (patients with Gilbert's disease are allowed to the study).
  • International normalized ratio >1.40.
  • Platelet count <100 x10^9/L due related to portal hypertension.
  • Clinically relevant renal dysfunction, including nephrotic syndrome, chronic kidney disease (determined based on the estimated glomerular filtration rate [eGFR] less than 60 ml/min/1.73 m^2).

Treatment and study plan

Specialized food - Plant-Based Meat Analog

Other

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

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

Primary outcomes

  1. cholesterol

    Time frame: baseline and day 14

    serum cholesterol change

  2. Low-density lipoproteins

    Time frame: baseline and day 14

    Serum concentrations of low-density lipoproteins change

  3. High-density lipoproteins

    Time frame: baseline and day 14

    Serum concentration of HDLP change

  4. triglycerides

    Time frame: baseline and day 14

    Serum concentration of triglycerides change

  5. C-reactive protein

    Time frame: baseline and day 14

    Serum concentration of C-reactive protein change

  6. urea

    Time frame: baseline and day 14

    serum concentration of urea change

  7. stool form

    Time frame: baseline and day 14

    Stool form change assessed with standard Bristol stool scale. Type 1 is characterized by separate hard lumps, hard to pass; this often observed in constipation; Type 4 - looks like a sausage or snake, smooth and soft (normal); Type 7 - watery, entirely liquid stool, observed in diarrhea; Mean values of stool forms by previous 7 days at baseline and on day 14 will be assessed to reflect a "change".

  8. Organoleptic qualities of the developed products

    Time frame: baseline and day 14

    Organoleptic assessment with the use of visual analogue scales (taste, colour, scent, texture) is to be used.

  9. stool frequency

    Time frame: baseline and day 14

    Mean stool frequency a day will be assessed at baseline and at the end of the study period to detect possible "change" in bowel habits related to product use

Study contacts

Contact information is provided by the study sponsor or research team.

Sergey Morozov, MD, PhD, DrSci

CONTACT

[email protected]

+79104681801

Vladimir Pilipenko, MD, PhD

CONTACT

[email protected]

+74996131091

Sponsors and collaborators

Lead sponsor

Federal State Budgetary Scientific Institution

Other Gov

Collaborators

  • Group of companies EFKO
  • Russian Science Foundation

Registry information

Official study title

Assessment of Tolerability of Specialized Foods of Vegetable Proteins and Their Influence on Lipid Profile in Patients With Non-alcoholic Fatty Liver Disease

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 10, 2024
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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