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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Specialized food - Plant-Based Meat Analog, standard isocalorie diet.
- Who it may be relevant to
- Registry conditions: Non-alcoholic Fatty Liver Disease NAFLD. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Other Specialized food - Plant-Based Meat Analog
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. - Other standard isocalorie diet
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
Primary outcome measures
- cholesterol [Time frame: baseline and day 14]
- Low-density lipoproteins [Time frame: baseline and day 14]
- High-density lipoproteins [Time frame: baseline and day 14]
- triglycerides [Time frame: baseline and day 14]
- C-reactive protein [Time frame: baseline and day 14]
- urea [Time frame: baseline and day 14]
- stool form [Time frame: baseline and day 14]
- Organoleptic qualities of the developed products [Time frame: baseline and day 14]
- stool frequency [Time frame: baseline and day 14]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06727279 · OGIG-19-76-30014/2024-2MB · 19-76-30014-P