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

NCT06727279 | Not Yet Recruiting DMC

• 2 other identifiers: OGIG-19-76-30014/2024-2MB19-76-30014-P
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Non-alcoholic Fatty Liver Disease NAFLD

Keywords

non-alcoholic fatty liver disease; vegetable protein; specialized foods; plant-based meat analogs; meat substitutes; tolerability

Outcome Measures

Primary Outcomes (9)

• cholesterol

  serum cholesterol change

  baseline and day 14

• Low-density lipoproteins

  Serum concentrations of low-density lipoproteins change

  baseline and day 14

• High-density lipoproteins

  Serum concentration of HDLP change

  baseline and day 14

• triglycerides

  Serum concentration of triglycerides change

  baseline and day 14

• C-reactive protein

  Serum concentration of C-reactive protein change

  baseline and day 14

• urea

  serum concentration of urea change

  baseline and day 14

• stool form

  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".

  baseline and day 14

• Organoleptic qualities of the developed products

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

  baseline and day 14

• stool frequency

  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

  baseline and day 14

Study Arms (2)

plant-based meat analog

EXPERIMENTAL

Patients with non-alcoholic fatty liver disease will receive iso-caloric diet with modified fat and protein content: 18.8 g/day animal proteins a day will be substituted by 13.0 g/day vegetable protein; 6.0 g/day animal fat will be substituted by 19.1 g/day vegetable fat. This modification undermines substitution of a portion of meat product made of standard (animal) meat (cutlet or schnitzel) by plant-based analog, based on soy-bean source. The taste will be masked by natural food flavoring (taste of chicken).

Other: Specialized food - Plant-Based Meat Analog

Control - standard iso-calorie diet

PLACEBO COMPARATOR

Iso-calorie diet (based on resting energy expenditures measurements) is provided to subjects with non-alcoholic fatty liver disease

Other: standard isocalorie diet

Interventions

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.

plant-based meat 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

Control - standard iso-calorie diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology: lead
• Group of companies EFKO: collaborator
• Russian Science Foundation: collaborator

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Vasily Isakov, MD, PhD, Professor

  Federal Research Center of Nutrition&Biotechnology

  STUDY CHAIR

Central Study Contacts

Sergey Morozov, MD, PhD, DrSci

CONTACT

+79104681801; morosoffsv@mail.ru

Vladimir Pilipenko, MD, PhD

CONTACT

+74996131091; pilipenkowork@rambler.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Chicken-flavoured plant-based meat analogs will be used in this study
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: September 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 5 years after study completion