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

NCT ID: NCT06727279

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

plant-based meat analog

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).

Group Type: EXPERIMENTAL

Specialized food - Plant-Based Meat Analog

Intervention Type: 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.

Control - standard iso-calorie diet

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

Group Type: PLACEBO_COMPARATOR

standard isocalorie diet

Intervention Type: 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

Interventions

Specialized food - Plant-Based Meat Analog

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.

Intervention Type: OTHER

standard isocalorie diet

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

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Group of companies EFKO

UNKNOWN

Sponsor Role: collaborator

Russian Science Foundation

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vasily Isakov, MD, PhD, Professor

Role: STUDY_CHAIR

Federal Research Center of Nutrition&Biotechnology

Central Contacts

Sergey Morozov, MD, PhD, DrSci

Role: CONTACT

morosoffsv@mail.ru

+79104681801

Vladimir Pilipenko, MD, PhD

Role: CONTACT

pilipenkowork@rambler.ru

+74996131091

Other Identifiers

19-76-30014-P

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

OGIG-19-76-30014/2024-2MB

Identifier Type: -

Identifier Source: org_study_id