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Histological Improvement of NASH With Prebiotic

NCT03184376 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-06-12

No results posted yet for this study

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.

Conditions

  • Non-Alcoholic Fatty Liver Disease

Interventions

DIETARY_SUPPLEMENT

Prebiotic oligofructose

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DIETARY_SUPPLEMENT

Placebo maltodextrin

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Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Raylene A Reimer, PhD, RD · The University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-28
Primary Completion
2015-12-16
Completion
2016-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03184376 on ClinicalTrials.gov