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

Assessment of Tolerability of Specialized Foods of Vegetable Proteins 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

Study Overview

• Status: Not yet recruiting
• Conditions: Non-alcoholic Fatty Liver Disease NAFLD
• Intervention / Treatment: Other: Specialized food - Plant-Based Meat Analog; Other: standard isocalorie diet

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergey Morozov, MD, PhD, DrSci; Phone Number: +79104681801; Email: morosoffsv@mail.ru
• Study Contact Backup: Name: Vladimir Pilipenko, MD, PhD; Phone Number: +74996131091; Email: pilipenkowork@rambler.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: 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.
Placebo Comparator: Control - standard iso-calorie diet; Iso-calorie diet (based on resting energy expenditures measurements) is provided to subjects with non-alcoholic fatty liver disease	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
• Collaborators: Russian Science Foundation; Group of companies EFKO
• Investigators: Study Chair: Vasily Isakov, MD, PhD, Professor, Federal Research Center of Nutrition&Biotechnology

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: tolerability; non-alcoholic fatty liver disease; vegetable protein; specialized foods; plant-based meat analogs; meat substitutes
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: OGIG-19-76-30014/2024-2MB; 19-76-30014-P (Other Grant/Funding Number: Russian Science Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data may be shared upon reasonable request to principal investigator
• IPD Sharing Time Frame: 5 years after study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No