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

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Status: Not yet enrolling

Conditions: Non-alcoholic Fatty Liver Disease NAFLD

Treatments: Other: standard isocalorie diet; Other: Specialized food - Plant-Based Meat Analog

Study type: Interventional

Funder types: Other

Identifiers

NCT06727279

19-76-30014-P (Other Grant/Funding Number)

OGIG-19-76-30014/2024-2MB

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

plant-based meat analog

Experimental group

Description:

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).

Treatment:

Other: Specialized food - Plant-Based Meat Analog

Control - standard iso-calorie diet

Placebo Comparator group

Description:

Iso-calorie diet (based on resting energy expenditures measurements) is provided to subjects with non-alcoholic fatty liver disease

Treatment:

Other: standard isocalorie diet