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The purpose of this present study is to evaluating whether prebiotics - ITF (Inulin/OFS 75/25) is effective in treating patients with non-alcoholic liver disease.
The study will include 60 patients with Non-alcoholic fatty liver disease (NAFLD) which will randomize to two groups, receiving either ITF (Inulin/oligofructose-OFS 75/25) or maltodextrin (placebo).
The trial will last for 26 weeks: Stage 1-Run-in period: Subjects will be followed to ascertain weight maintenance. Stage 2- Randomized intervention period: Subjects will be assigned to receive 16 gram/day of ITF or maltodextrin. Both ITF and placebo will be provided in identical opaque packages and both subjects and researchers will be blinded to the content.
After signing informed (-2 week) consent, the following data will be collected: demographics, lifestyle habits including dietary questionnaires, and medical history. At week 0, week 12 and week 24 all the following tests will be performed: Vital Signs: blood pressure, anthropometric measurements, body composition determined by bioelectrical impedance analysis (BIA). Biochemical blood tests: liver function tests fasting glucose insulin & lipid profile, CRP (an inflammation marker), SCFA, BCAA, and LBP and FGF 19. Fecal samples: fecal samples will be used for microbiota composition analysis, and BA analysis. Assessment of liver status At week 0 and 24 by using magnetic resonance spectroscopy (1H-MRS), SteatoTest and NashTest (FibroMaxâ„¢) and by liver enzymes for evaluating steohepatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITF (Inulin/OFS 75/25) | Experimental | 16 gram/day of ITF (Inulin/OFS 75/25) |
|
| placebo | Placebo Comparator | 16 gram/day of maltodextrin (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITF (Inulin/OFS 75/25) | Dietary Supplement | Participants will consume 16 g/day ITF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the severity of NAFLD | Determined by
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of gut microbiota composition. | Quantitative evaluation of the change in the composition of bacteria from stool samples | 12 weeks |
| Change from baseline in glycemic control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaakov Maor, Dr | Kaplan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaplan Medical Center | Rehovot | 81207 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23135760 | Background | Dewulf EM, Cani PD, Claus SP, Fuentes S, Puylaert PG, Neyrinck AM, Bindels LB, de Vos WM, Gibson GR, Thissen JP, Delzenne NM. Insight into the prebiotic concept: lessons from an exploratory, double blind intervention study with inulin-type fructans in obese women. Gut. 2013 Aug;62(8):1112-21. doi: 10.1136/gutjnl-2012-303304. Epub 2012 Nov 7. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007333 | Insulin Resistance |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Placebo | Dietary Supplement | Participants will consume 16 g/day maltodextrin |
|
|
Determine by OGTT.
| 12 weeks |
| Change from baseline in insulin sensitivity | Which will be determined by a fasting Glucose and Insulin blood tests and Calculate homeostasis model assessment (HOMA). | 12 weeks |
| Change from baseline in lipid profile | Which will be determined by blood test for lipid profile - Triglycerides, cholesterol-LDL and cholesterol-HDL | 12 weeks |
| D006946 |
| Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |