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

Not Applicable

Not yet recruiting

• Conditions: Non-alcoholic Fatty Liver Disease NAFLD

• Registration Number: NCT06727279
• Lead Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Study Start: 2025-01-20
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
cholesterol	baseline and day 14	serum cholesterol change
Low-density lipoproteins	baseline and day 14	Serum concentrations of low-density lipoproteins change
High-density lipoproteins	baseline and day 14	Serum concentration of HDLP change
triglycerides	baseline and day 14	Serum concentration of triglycerides change
C-reactive protein	baseline and day 14	Serum concentration of C-reactive protein change
urea	baseline and day 14	serum concentration of urea change
stool form	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	baseline and day 14	Organoleptic assessment with the use of visual analogue scales (taste, colour, scent, texture) is to be used.
stool frequency	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