Non-alcoholic Fatty Liver Disease NAFLDNCT06727279
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
A study testing Specialized food - Plant-Based Meat Analog and standard isocalorie diet in people with Non-alcoholic Fatty Liver Disease NAFLD, run by Federal State Budgetary Scientific Institution.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease NAFLD
- What is being tested?
- Specialized food - Plant-Based Meat Analog and standard isocalorie diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to participate;
- Confirmed diagnosis of non-alcoholic fatty liver disease based on EASL guidelines.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- Non-alcoholic Fatty Liver Disease NAFLD
- Being tested
- Specialized food - Plant-Based Meat Analog, standard isocalorie diet
- Keywords
- non-alcoholic fatty liver disease, vegetable protein, specialized foods, plant-based meat analogs, meat substitutes, tolerability
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized food - Plant-Based Meat AnalogOther
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 dietOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Other: standard isocalorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
cholesterol
serum cholesterol change
Measured: baseline and day 14
Low-density lipoproteins
Serum concentrations of low-density lipoproteins change
Measured: baseline and day 14
High-density lipoproteins
Serum concentration of HDLP change
Measured: baseline and day 14
triglycerides
Serum concentration of triglycerides change
Measured: baseline and day 14
C-reactive protein
Serum concentration of C-reactive protein change
Measured: baseline and day 14
urea
serum concentration of urea change
Measured: 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".
Measured: 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.
Measured: 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
Measured: baseline and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start15 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver Disease NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution
- Sponsor type
- Other government
- Collaborators
- EFKO Group, Russian Science Foundation
- Responsible party
- Sponsor
- Investigators
- Vasily Isakov, MD, PhD, Professor, Study chair, Federal Research Center of Nutrition&Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727279
- Sponsor's protocol ID
- OGIG-19-76-30014/2024-2MB
- Other IDs
- 19-76-30014-P
- Status last verified
- Aug 2025
- First submitted
- 6 Dec 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be shared upon reasonable request to principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tolerability of Specialized Foods of Vegetable Proteins and Their Influence on Lipid Profile in Patients With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06727279
- Acronym / sponsor ID
- OGIG-19-76-30014/2024-2MB
- Conditions
- Non-alcoholic Fatty Liver Disease NAFLD
- Keywords
- non-alcoholic fatty liver disease, vegetable protein, specialized foods, plant-based meat analogs, meat substitutes, tolerability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federal State Budgetary Scientific InstitutionOther government
- Collaborators
- EFKO Group, Russian Science Foundation
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plant-based meat analog | Experimental | Other: Specialized food - Plant-Based Meat AnalogPatients 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). |
| Control - standard iso-calorie diet | Placebo comparator | Other: standard isocalorie dietIso-calorie diet (based on resting energy expenditures measurements) is provided to subjects with non-alcoholic fatty liver disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willingness to participate;
- Confirmed diagnosis of non-alcoholic fatty liver disease based on EASL guidelines.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialized food - Plant-Based Meat AnalogExperimental 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. | Other | plant-based meat analog |
| standard isocalorie dietIsocalorie (based on resting energy expenditures measurements) diet is provided to subjects of the control group with no modification of the protein and fat content | Other | Control - standard iso-calorie diet |
Primary outcome
cholesterol
Time frame: baseline and day 14
serum cholesterol change
Low-density lipoproteins
Time frame: baseline and day 14
Serum concentrations of low-density lipoproteins change
High-density lipoproteins
Time frame: baseline and day 14
Serum concentration of HDLP change
triglycerides
Time frame: baseline and day 14
Serum concentration of triglycerides change
C-reactive protein
Time frame: baseline and day 14
Serum concentration of C-reactive protein change
urea
Time frame: baseline and day 14
serum concentration of urea change
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".
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Yes. Data may be shared upon reasonable request to principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vasily Isakov, MD, PhD, Professor study chair
Federal Research Center of Nutrition&Biotechnology
Questions about this trial
What is this clinical trial studying?
A study testing Specialized food - Plant-Based Meat Analog and standard isocalorie diet in people with Non-alcoholic Fatty Liver Disease NAFLD, run by Federal State Budgetary Scientific Institution.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergey Morozov, MD, PhD, DrSci (+79104681801, morosoffsv@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cholesterol (time frame: baseline and day 14). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.