NCT02642172

Prebiotics in Patients With Non-alcoholic Liver Disease

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Kaplan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-alcoholic Fatty Liver Disease
• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ITF (Inulin/OFS 75/25)	Participants will consume 16 g/day ITF
DIETARY_SUPPLEMENT	Placebo	Participants will consume 16 g/day maltodextrin

Timeline

• Start date: 2016-01-01
• Primary completion: 2023-03-20
• Completion: 2023-03-20
• First posted: 2015-12-30
• Last updated: 2023-11-29

Locations

1 site across 1 country: Israel