Prebiotics in Patients With Non-alcoholic Liver Disease

Not Applicable

Completed

• Conditions: Non-alcoholic Fatty Liver Disease; Metabolic Syndrome
• Interventions: Dietary Supplement: ITF (Inulin/OFS 75/25); Dietary Supplement: Placebo

• Registration Number: NCT02642172
• Lead Sponsor: Kaplan Medical Center

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.

Study Timeline

• Study First Submitted: 2015-12-13
• Study First Submitted QC: 2015-12-23
• Study First Posted: 2015-12-30
• Study Start: 2016-01
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-25
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ITF (Inulin/OFS 75/25)	ITF (Inulin/OFS 75/25)	16 gram/day of ITF (Inulin/OFS 75/25)
placebo	Placebo	16 gram/day of maltodextrin (placebo)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline in glycemic control	12 weeks	Determine by OGTT.
Change from baseline in lipid profile	12 weeks	Which will be determined by blood test for lipid profile - Triglycerides, cholesterol-LDL and cholesterol-HDL
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 insulin sensitivity	12 weeks	Which will be determined by a fasting Glucose and Insulin blood tests and Calculate homeostasis model assessment (HOMA).

Trial Locations

Locations (1)

Kaplan Medical Center; 🇮🇱 Rechovot, Israel