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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
45
Oligofructose-enriched inulin (Synergy1)
Maltodextrin
All participants will receive 10 one-on-one sessions with a Registered Dietitian designed to achieve 10% weight loss over 6 months. The sessions will focus on nutrition education and behavior counseling to reduce food intake and improve dietary quality.
University of Calgary
Calgary, Alberta, Canada
Change in Liver Fat
Assessed via MRI
Time frame: 24 weeks
Change in Liver Fibrosis
Assessed via FibroScan (transient elastography)
Time frame: 24 weeks
Change in Liver Injury
Assessed via Fibrotest Score (composite score from serum biochemical markers: alfa2-macroglobulin, apolipoproteinA1, total bilirubin, haptoglobin, gamma glutamyl transpeptidase, alanine aminotransferase)
Time frame: 24 weeks
Change in Glucose Tolerance
Assessed via an oral glucose tolerance test
Time frame: 24 weeks
Change in Glycemic Control
Assessed via HbA1c
Time frame: 24 weeks
Change in Subjective Appetite
Assessed via Subjective appetite ratings on a visual analogue scale
Time frame: 24 weeks
Change in Satiety Hormones
Assessed in serum as pg/ml (Ghrelin, Glucagon-like peptide-1, Glucose-dependent insulinotropic polypeptide, leptin and Peptide tyrosine tyrosine)
Time frame: 24 weeks
Change in Body Composition
Assessed via dual x-ray absorptiometry
Time frame: 24 weeks
Change in Quality of Life
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Assessed via the Short Form-36v2 Health Survey questionnaire
Time frame: 24 weeks
Dietary Adherence
Assessed via adherence to prescribed versus measured energy intake assessed by food records
Time frame: 24 weeks
Examine mechanisms related to prebiotic-induced changes in gut microbiota, their metabolic byproducts, and de novo lipogenesis
Via investigating gut microbiota shot-gun sequencing and measurement of volatile organic compounds and de novo lipogenesis using deuterium incorporation
Time frame: 24 weeks