Other Clinical Trial - Histological Improvement of NASH With Prebiotic

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Fatty Liver
Liver Diseases
Non-Alcoholic Fatty Liver Disease

Clinical Trial Details

NCT number	NCT03184376
Study type	Interventional
Source	University of Calgary
Contact
Status	Completed
Phase	N/A
Start date	February 28, 2012
Completion date	May 30, 2016

View Details

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