Metabolic Syndrome, Non-alcoholic Fatty Liver Disease
Conditions
Keywords
Inulin, OFS (oligofructose)
Brief summary
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.
Detailed description
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 (FibroMax™) and by liver enzymes for evaluating steohepatitis.
Interventions
DIETARY_SUPPLEMENTITF (Inulin/OFS 75/25)
Participants will consume 16 g/day ITF
DIETARY_SUPPLEMENTPlacebo
Participants will consume 16 g/day maltodextrin
Sponsors
Kaplan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of NAFLD based on fatty infiltration detection by ultrasonography and alanine aminotransferase levels of (ALT) ≥ 30 U/L male ≥ 19 U/L females. * Over-weight (BMI ≥ 27 kg/m2) who fulfill the criteria of the National Cholesterol Education Program (NCEP) metabolic syndrome * Willing to sign informed consent to participate in the study * Patients without diabetes or with well-controlled diabetes (HbA1C \< 7.5%) who are treated by diet ± metformin
Exclusion criteria
* Pregnancy * Uncontrolled diabetes * Diabetic treatment other than metformin, unusual diets (vegetarian, vegan), usage of antibiotics, probiotics or prebiotics up to 6 months prior to study, alcohol abuse, presence of gastrointestinal or mental disorders, weight-loss treatment, bariatric surgery * Serious medical conditions * Evidence of another etiology for chronic liver disease such as: hepatitis B, hepatitis C, HIV, autoimmune diseases and metabolic diseases, medications with known hepatotoxicity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the severity of NAFLD | 12 weeks | Determined by 1. liver fat fraction measured by magnetic resonance spectroscopy (1H-MRS) 2. Blood test for calculate Inflammation score using SteatoTest and NashTest (FibroMax™) 3. Blood test for liver enzyme |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of gut microbiota composition. | 12 weeks | Quantitative evaluation of the change in the composition of bacteria from stool samples |
| Change from baseline in glycemic control | 12 weeks | Determine by OGTT. |
| Change from baseline in insulin sensitivity | 12 weeks | Which will be determined by a fasting Glucose and Insulin blood tests and Calculate homeostasis model assessment (HOMA). |
| Change from baseline in lipid profile | 12 weeks | Which will be determined by blood test for lipid profile - Triglycerides, cholesterol-LDL and cholesterol-HDL |
Countries
Israel
Outcome results
None listed