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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prebiotic Fibre | Experimental | The intervention group will receive two 8g packets/day of prebiotic fibre to add to 250 ml of water and consume 30 minutes prior to breakfast and dinner. |
|
| Placebo | Placebo Comparator | The control group will receive two 3g packets/day of maltodextrin to add to 250 ml of water and consume 30 minutes prior to breakfast and dinner. |
|
| Weight Loss | Other | All participants will be supported through Registered Dietitian visits to achieve approximately 10% weight loss. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic fibre | Dietary Supplement | Oligofructose-enriched inulin (Synergy1) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Liver Fat | Assessed via MRI | 24 weeks |
| Change in Liver Fibrosis | Assessed via FibroScan (transient elastography) | 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) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glucose Tolerance | Assessed via an oral glucose tolerance test | 24 weeks |
| Change in Glycemic Control | Assessed via HbA1c | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raylene A Reimer, PhD, RD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40172664 | Derived | Mayengbam S, Raman M, Parnell JA, Eksteen B, Lambert JE, Eller LK, Nicolucci AC, Aktary ML, Reimer RA. Effects of combined prebiotic fiber supplementation and weight loss counseling in adults with metabolic dysfunction-associated steatotic liver disease: a randomized controlled trial. Eur J Nutr. 2025 Apr 2;64(4):144. doi: 10.1007/s00394-025-03660-7. | |
| 26635079 |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D015431 | Weight Loss |
| D009765 | Obesity |
| D005234 | Fatty Liver |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
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| Placebo |
| Dietary Supplement |
Maltodextrin |
|
| Weight Loss | Behavioral | 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. |
|
| Change in Subjective Appetite | Assessed via Subjective appetite ratings on a visual analogue scale | 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) | 24 weeks |
| Change in Body Composition | Assessed via dual x-ray absorptiometry | 24 weeks |
| Change in Quality of Life | Assessed via the Short Form-36v2 Health Survey questionnaire | 24 weeks |
| Dietary Adherence | Assessed via adherence to prescribed versus measured energy intake assessed by food records | 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 | 24 weeks |
| Lambert JE, Parnell JA, Eksteen B, Raman M, Bomhof MR, Rioux KP, Madsen KL, Reimer RA. Gut microbiota manipulation with prebiotics in patients with non-alcoholic fatty liver disease: a randomized controlled trial protocol. BMC Gastroenterol. 2015 Dec 3;15:169. doi: 10.1186/s12876-015-0400-5. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |