Prebiotics in Patients With Non-alcoholic Liver Disease

Sponsor

Kaplan Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02642172

Collaborator

(none)

Enrollment

Location

Arms

108

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-alcoholic Fatty Liver Disease Metabolic Syndrome	Dietary Supplement: ITF (Inulin/OFS 75/25) Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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.

Actual Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ITF (Inulin/OFS 75/25) 16 gram/day of ITF (Inulin/OFS 75/25)	Dietary Supplement: ITF (Inulin/OFS 75/25) Participants will consume 16 g/day ITF Other Names: Prebiotics- Inulin, OFS - oligofructose
Placebo Comparator: placebo 16 gram/day of maltodextrin (placebo)	Dietary Supplement: Placebo Participants will consume 16 g/day maltodextrin Other Names: maltodextrin

Arm

Intervention/Treatment

Experimental: ITF (Inulin/OFS 75/25)

16 gram/day of ITF (Inulin/OFS 75/25)

Dietary Supplement: ITF (Inulin/OFS 75/25)

Participants will consume 16 g/day ITF

Other Names:

Prebiotics- Inulin, OFS - oligofructose

Placebo Comparator: placebo

16 gram/day of maltodextrin (placebo)

Dietary Supplement: Placebo

Participants will consume 16 g/day maltodextrin

Other Names:

maltodextrin

Outcome Measures

Primary Outcome Measures

Change from baseline in the severity of NAFLD [12 weeks]
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.