NCT06727279Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 6 Dec 2024
- Start date
- 15 Sept 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Federal State Budgetary Scientific Institution
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06727279
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 15 Sept 2025 to the primary completion date, 31 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Past bariatric surgery.
- Clinically relevant acute cardiovascular event within 6 months prior to screening.
- 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.
- Positive test for to human immunodeficiency virus antibodies .
Other illness
- Chronic heart failure (I-IV class by NYHA).
- Uncontrolled arterial hypertension despite optimal anti-hypertensive therapy.
- Diabetes mellitus type 1.
- Hypersensitivity to the studied product or any of its components.
- Any medical conditions that may significantly affect life expectancy, including known cancers;
- Any clinically significant immunological, endocrine, haematological, gastrointestinal, neurological or psychiatric diseases;
Lab values
- Serum glycated hemoglobin \[HbA1c\] concentrations \>9.0%.
- 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).
- 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).
Other
- 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.
- 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.
- International normalized ratio \>1.40.
Who the study is looking for
- Willingness to participate;
- Confirmed diagnosis of non-alcoholic fatty liver disease based on EASL guidelines.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.