Prebiotics in Patients With Non-alcoholic Liver Disease

Kaplan Medical Center24 enrolled

Overview

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 (FibroMax™) and by liver enzymes for evaluating steohepatitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Non-alcoholic Fatty Liver Disease Metabolic Syndrome

Interventions

ITF (Inulin/OFS 75/25)DIETARY_SUPPLEMENT

Participants will consume 16 g/day ITF

PlaceboDIETARY_SUPPLEMENT

Participants will consume 16 g/day maltodextrin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kaplan Medical Center

Rehovot, Israel

Outcomes

Primary Outcomes

Change from baseline in the severity of NAFLD

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

Time frame: 12 weeks

Secondary Outcomes

Change from baseline of gut microbiota composition.

Quantitative evaluation of the change in the composition of bacteria from stool samples

Time frame: 12 weeks

Change from baseline in glycemic control

Determine by OGTT.

Time frame: 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).

Time frame: 12 weeks

Change from baseline in lipid profile

Which will be determined by blood test for lipid profile - Triglycerides, cholesterol-LDL and cholesterol-HDL

Time frame: 12 weeks

Data from ClinicalTrials.gov

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