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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prebiotic | Experimental | Prebiotic oligofructose (Orafti P95, Beneo-Orafti Inc., Tienen, Belgium) taken 8g orally per day for 12 weeks followed by 16g per day for 24 weeks. |
|
| Placebo | Placebo Comparator | Placebo maltodextrin (isocaloric to prebiotic) taken 3.3g orally per day for 12 weeks followed by 6.6g per day for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic oligofructose | Dietary Supplement | Powder format |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Histological change | Nonalcoholic fatty liver disease activity score | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Body lean and fat mass | 9 months |
| Body weight | Body weight measurement | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raylene A Reimer, PhD, RD | The University of Calgary | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29779170 | Derived | Bomhof MR, Parnell JA, Ramay HR, Crotty P, Rioux KP, Probert CS, Jayakumar S, Raman M, Reimer RA. Histological improvement of non-alcoholic steatohepatitis with a prebiotic: a pilot clinical trial. Eur J Nutr. 2019 Jun;58(4):1735-1745. doi: 10.1007/s00394-018-1721-2. Epub 2018 May 19. |
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Other researchers would need to make an individual inquiry.
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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Single-blind, placebo controlled, randomized trial
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Participants were blinded to the treatment allocation. Oligofructose and maltodextrin taste and look the same (white powder) and both were placed in identical foil packaging.
| Placebo maltodextrin |
| Dietary Supplement |
Powder format |
|
| Glucose tolerance | Oral glucose tolerance test | 9 months |
| Gut microbiota | Intestinal microbiota composition | 9 months |
| Serum total cholesterol | Total cholesterol | 9 months |
| Serum LDL cholesterol | Low-density lipoprotein cholesterol | 9 months |
| Serum triglycerides | Triglycerides | 9 months |
| Serum HDL cholesterol | High-density lipoprotein cholesterol | 9 months |
| Serum IL-6 | Interleukin-6 | 9 months |
| Serum TNF-alpha | Tumor necrosis factor - alpha | 9 months |