Clinical trial NCT06727279: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease NAFLD
Keywords: non-alcoholic fatty liver disease
vegetable protein
specialized foods
plant-based meat analogs
meat substitutes
tolerability
Lead sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Sponsor class: OTHER
Collaborators: name: Group of companies EFKO
name: Russian Science Foundation
First posted: 2024-12-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


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).

Primary outcomes:
measure: cholesterol
timeFrame: baseline and day 14
measure: Low-density lipoproteins
timeFrame: baseline and day 14
measure: High-density lipoproteins
timeFrame: baseline and day 14
measure: triglycerides
timeFrame: baseline and day 14
measure: C-reactive protein
timeFrame: baseline and day 14
measure: urea
timeFrame: baseline and day 14
measure: stool form
timeFrame: baseline and day 14
measure: Organoleptic qualities of the developed products
timeFrame: baseline and day 14
measure: stool frequency
timeFrame: baseline and day 14
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal Research Center of Nutrition&Biotechnology
name: Vasily Isakov, MD, PhD, Professor
role: STUDY_CHAIR
References: