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| ID | Type | Description | Link |
|---|---|---|---|
| 19-76-30014-P | Other Grant/Funding Number | Russian Science Foundation |
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| Name | Class |
|---|---|
| Group of companies EFKO | UNKNOWN |
| Russian Science Foundation | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| plant-based meat analog | Experimental | 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). |
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| Control - standard iso-calorie diet | Placebo Comparator | Iso-calorie diet (based on resting energy expenditures measurements) is provided to subjects with non-alcoholic fatty liver disease |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specialized food - Plant-Based Meat Analog | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| cholesterol | serum cholesterol change | baseline and day 14 |
| Low-density lipoproteins | Serum concentrations of low-density lipoproteins change | baseline and day 14 |
| High-density lipoproteins | Serum concentration of HDLP change | baseline and day 14 |
| triglycerides | Serum concentration of triglycerides change | baseline and day 14 |
| C-reactive protein | Serum concentration of C-reactive protein change | baseline and day 14 |
| urea | serum concentration of urea change | baseline and day 14 |
| stool form | 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". | baseline and day 14 |
| Organoleptic qualities of the developed products |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergey Morozov, MD, PhD, DrSci | Contact | +79104681801 | morosoffsv@mail.ru | |
| Vladimir Pilipenko, MD, PhD | Contact | +74996131091 | pilipenkowork@rambler.ru |
| Name | Affiliation | Role |
|---|---|---|
| Vasily Isakov, MD, PhD, Professor | Federal Research Center of Nutrition&Biotechnology | Study Chair |
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Data may be shared upon reasonable request to principal investigator
5 years after study completion
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Chicken-flavoured plant-based meat analogs will be used in this study
| standard isocalorie diet | Other | 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 |
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Organoleptic assessment with the use of visual analogue scales (taste, colour, scent, texture) is to be used.
| baseline and day 14 |
| stool frequency | 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 | baseline and day 14 |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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