Histological Improvement of NASH With Prebiotic

Not Applicable

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Dietary Supplement: Prebiotic oligofructose; Dietary Supplement: Placebo maltodextrin

• Registration Number: NCT03184376
• Lead Sponsor: University of Calgary

Brief Summary

This trial will investigate the therapeutic potential of a prebiotic supplement to improve histological parameters of NASH. In a single-blind, placebo controlled, randomized pilot trial will be conduced in individuals with liver biopsy confirmed NASH (Non-alcoholic fatty liver activity score (NAS) ≥ 5). Participants will be randomized to receive oligofructose (8 g/day for 12 weeks and 16g/day for 24 weeks) or isocaloric placebo for 9 months. The primary outcome measure is the change in liver biopsy NAS score and the secondary outcomes include changes in body weight, body composition, glucose tolerance, serum lipids, inflammatory markers, and gut microbiota.

Detailed Description

Oligofructose and maltodextrin are both white powders that taste and look the same. They were both package in individual foil packets. Participants were blinded to the treatment allocation. Adherence to supplement protocol was monitored throughout the study through direct questioning and counting unused supplement packages. Participants were asked to maintain their usual physical activity.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-02-28
• Primary Completion: 2015-12-16
• Study Completion: 2016-05-30
• Status Verified: 2017-06
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-09
• Last Update Submitted: 2017-06-09
• Study First Posted: 2017-06-12
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Liver biopsy confirmed NASH (NAS score greater than or equal to 5)
• BMI >25 kg/m2 (Caucasians)
• >23 kg/m2 (Asians)
• History of Serum ALT >1.5X upper normal limit
• No changes in lipid-lowering or diabetes medication over previous three months
• Ability to provide informed consent

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Exclusion Criteria

• alcohol consumption >20g/day (women) or >30g/day (men)
• alternate etiology for abnormal liver enzymes
• decompensated liver disease
• use of orlistat, liraglutide, prebiotic, probiotic, or antibiotic within 3 months prior to enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prebiotic	Prebiotic oligofructose	Prebiotic oligofructose (Orafti P95, Beneo-Orafti Inc., Tienen, Belgium) taken 8g orally per day for 12 weeks followed by 16g per day for 24 weeks.
Placebo	Placebo maltodextrin	Placebo maltodextrin (isocaloric to prebiotic) taken 3.3g orally per day for 12 weeks followed by 6.6g per day for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Histological change	9 months	Nonalcoholic fatty liver disease activity score

Secondary Outcome Measures

Name	Time	Method
Body composition	9 months	Body lean and fat mass
Glucose tolerance	9 months	Oral glucose tolerance test
Serum TNF-alpha	9 months	Tumor necrosis factor - alpha
Serum HDL cholesterol	9 months	High-density lipoprotein cholesterol
Serum IL-6	9 months	Interleukin-6
Serum triglycerides	9 months	Triglycerides
Gut microbiota	9 months	Intestinal microbiota composition
Body weight	9 months	Body weight measurement
Serum total cholesterol	9 months	Total cholesterol
Serum LDL cholesterol	9 months	Low-density lipoprotein cholesterol