Clinical Trial: Prebiotic Fibre Supplementation and Gut Microbiota in Non-alcoholic Fatty Liver Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prebiotic Fibre Supplementation and Gut Microbiota in Non-alcoholic Fatty Liver Disease

Brief Summary: Non-alcoholic fatty liver disease (NAFLD) is a condition where accumulation of fat in the liver leads to metabolic dysfunction. Currently there are no approved treatments for NAFLD. Part of the metabolic dysfunction may arise through changes in the gut microbiota. Prebiotic fibres have beneficial effects on glucose tolerance, body weight, and gut microbiota; therefore they may have potential as part of a dietary strategy for NAFLD treatment.

Detailed Summary:

The main objective of this study is to assess the effect of prebiotic fibre supplementation, in conjunction with diet-induced weight loss, on reduction in liver fat and injury.

Primary Objective - determine the change in hepatic injury (fibrosis and inflammation) and hepatic fat (percent fat) over 6 months in NAFLD patients treated with prebiotic or placebo during weight loss.

Secondary Objectives - determine the changes in appetite, body composition, glycemic and insulinemic responses, quality of life with prebiotic or placebo during weight loss, and examine mechanisms related to prebiotic-induced changes in gut microbiota and lipogenesis.


Sponsor: University of Calgary

Current Primary Outcome:

  • Change in Liver Fat [ Time Frame: 24 weeks ]
    Assessed via MRI
  • Change in Liver Fibrosis [ Time Frame: 24 weeks ]
    Assessed via FibroScan (transient elastography)
  • Change in Liver Injury [ Time Frame: 24 weeks ]
    Assessed via Fibrotest Score (composite score from serum biochemical markers: alfa2-macroglobulin, apolipoproteinA1, total bilirubin, haptoglobin, gamma glutamyl transpeptidase, alanine aminotransferase)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Glucose Tolerance [ Time Frame: 24 weeks ]
    Assessed via an oral glucose tolerance test
  • Change in Glycemic Control [ Time Frame: 24 weeks ]
    Assessed via HbA1c
  • Change in Subjective Appetite [ Time Frame: 24 weeks ]
    Assessed via Subjective appetite ratings on a visual analogue scale
  • Change in Satiety Hormones [ Time Frame: 24 weeks ]
    Assessed in serum as pg/ml (Ghrelin, Glucagon-like peptide-1, Glucose-dependent insulinotropic polypeptide, leptin and Peptide tyrosine tyrosine)
  • Change in Body Composition [ Time Frame: 24 weeks ]
    Assessed via dual x-ray absorptiometry
  • Change in Quality of Life [ Time Frame: 24 weeks ]
    Assessed via the Short Form-36v2 Health Survey questionnaire
  • Dietary Adherence [ Time Frame: 24 weeks ]
    Assessed via adherence to prescribed versus measured energy intake assessed by food records
  • Examine mechanisms related to prebiotic-induced changes in gut microbiota, their metabolic byproducts, and de novo lipogenesis [ Time Frame: 24 weeks ]
    Via investigating gut microbiota shot-gun sequencing and measurement of volatile organic compounds and de novo lipogenesis using deuterium incorporation


Original Secondary Outcome: Same as current

Information By: University of Calgary

Dates:
Date Received: September 30, 2015
Date Started: May 2015
Date Completion: May 2019
Last Updated: May 10, 2016
Last Verified: May 2016