Prebiotics in Patients With Non-alcoholic Liver Disease
NCT ID: NCT02642172
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2016-01-31
2023-03-20
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ITF (Inulin/OFS 75/25)
16 gram/day of ITF (Inulin/OFS 75/25)
ITF (Inulin/OFS 75/25)
Participants will consume 16 g/day ITF
placebo
16 gram/day of maltodextrin (placebo)
Placebo
Participants will consume 16 g/day maltodextrin
Interventions
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ITF (Inulin/OFS 75/25)
Participants will consume 16 g/day ITF
Placebo
Participants will consume 16 g/day maltodextrin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Kaplan Medical Center
OTHER
Responsible Party
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Yaakov Maor
Principal Investigator
Principal Investigators
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Yaakov Maor, Dr
Role: PRINCIPAL_INVESTIGATOR
Kaplan Medical Center
Locations
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Kaplan Medical Center
Rehovot, , Israel
Countries
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References
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Dewulf EM, Cani PD, Claus SP, Fuentes S, Puylaert PG, Neyrinck AM, Bindels LB, de Vos WM, Gibson GR, Thissen JP, Delzenne NM. Insight into the prebiotic concept: lessons from an exploratory, double blind intervention study with inulin-type fructans in obese women. Gut. 2013 Aug;62(8):1112-21. doi: 10.1136/gutjnl-2012-303304. Epub 2012 Nov 7.
Other Identifiers
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PN-837-CTIL
Identifier Type: -
Identifier Source: org_study_id