Non-alcoholic Fatty Liver Disease NAFLD
Conditions
Keywords
non-alcoholic fatty liver disease, vegetable protein, specialized foods, plant-based meat analogs, meat substitutes, tolerability
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
Interventions
OTHERSpecialized 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.
OTHERstandard 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
Sponsors
Group of companies EFKO
Russian Science Foundation
Federal State Budgetary Scientific Institution Federal Research Centre of Nutrition, Biotechnology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Chicken-flavoured plant-based meat analogs will be used in this study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactSergey Morozov, MD, PhD, DrSci
Backup ContactVladimir Pilipenko, MD, PhD
Outcome results
None listed