Histological Improvement of NASH With Prebiotic

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-28

Study Completion Date

2016-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-blind, placebo controlled, randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants were blinded to the treatment allocation. Oligofructose and maltodextrin taste and look the same (white powder) and both were placed in identical foil packaging.

Study Groups

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Prebiotic

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.

Group Type EXPERIMENTAL

Prebiotic oligofructose

Intervention Type DIETARY_SUPPLEMENT

Powder format

Placebo

Placebo maltodextrin (isocaloric to prebiotic) taken 3.3g orally per day for 12 weeks followed by 6.6g per day for 24 weeks.

Group Type PLACEBO_COMPARATOR

Placebo maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Powder format

Interventions

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Prebiotic oligofructose

Powder format

Intervention Type DIETARY_SUPPLEMENT

Placebo maltodextrin

Powder format

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No