Prebiotics in Patients With Non-alcoholic Liver Disease
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|ClinicalTrials.gov Identifier: NCT02642172|
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-alcoholic Fatty Liver Disease Metabolic Syndrome||Dietary Supplement: ITF (Inulin/OFS 75/25) Dietary Supplement: Placebo||Not Applicable|
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 20 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. Stage 3- Extension period: All patients will receive 16 gram/day of ITF for 8 weeks.
After signing informed consent, the following data will be collected: demographics, lifestyle habits including dietary questionnaires, and medical history. At the end of week 2, week 12 and week 20 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, 75 gram oral glucose tolerance test (OGTT), 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 2, 12, and 20 by using magnetic resonance spectroscopy (1H-MRS), SteatoTest and NashTest (FibroMax™) and by liver enzymes for evaluating steohepatitis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 :||January 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
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 Name: Prebiotics- Inulin, OFS - oligofructose
Placebo Comparator: placebo
16 gram/day of maltodextrin (placebo)
Dietary Supplement: Placebo
Participants will consume 16 g/day maltodextrin
Other Name: maltodextrin
- Change from baseline in the severity of NAFLD [ Time Frame: 12 weeks ]
- 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
- Change from baseline of gut microbiota composition. [ Time Frame: 12 weeks ]Quantitative evaluation of the change in the composition of bacteria from stool samples
- Change from baseline in glycemic control [ Time Frame: 12 weeks ]Determine by OGTT.
- Change from baseline in insulin sensitivity [ Time Frame: 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 [ Time Frame: 12 weeks ]Which will be determined by blood test for lipid profile - Triglycerides, cholesterol-LDL and cholesterol-HDL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642172
|Contact: Yaakov Maor, Dremail@example.com|
|Contact: Naama Reshef, M.sc Nutrfirstname.lastname@example.org|
|Kaplan Medical Center||Recruiting|
|Rechovot, Israel, 81207|
|Contact: Naama reshef +972506705552 email@example.com|
|Principal Investigator:||Yaakov Maor, Dr||Kaplan Medical Center|