Prebiotics in Patients With Non-alcoholic Liver Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double - Blind Study With Two Parallel Arms for 4 Months (20 Weeks), Evaluating the Effectiveness of the Prebiotics in Patients With Non-alcoholic Liver Disease.

Conditions
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Non-alcoholic Fatty Liver Disease, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: ITF (Inulin/OFS 75/25)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITF (Inulin/OFS 75/25)<br>16 gram/day of ITF (Inulin/OFS 75/25) | Dietary Supplement: ITF (Inulin/OFS 75/25)<br>* Participants will consume 16 g/day ITF<br>* Other names: Prebiotics- Inulin, OFS - oligofructose;|
| Placebo Comparator: placebo<br>16 gram/day of maltodextrin (placebo) | Dietary Supplement: Placebo<br>* Participants will consume 16 g/day maltodextrin<br>* Other names: maltodextrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the severity of NAFLD | Determined by liver fat fraction measured by magnetic resonance spectroscopy (1H-MRS) Blood test for calculate Inflammation score using SteatoTest and NashTest (FibroMax™) Blood test for liver enzyme | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inulin, OFS (oligofructose)