Non-Alcoholic Fatty Liver Disease
Conditions
Keywords
Gut microbiota, Prebiotic, Liver biopsy, Oligofructose
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTPrebiotic oligofructose
Powder format
DIETARY_SUPPLEMENTPlacebo maltodextrin
Powder format
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Single-blind, placebo controlled, randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Liver biopsy confirmed NASH (NAS score greater than or equal to 5) * BMI \>25 kg/m2 (Caucasians) * \>23 kg/m2 (Asians) * History of Serum ALT \>1.5X upper normal limit * No changes in lipid-lowering or diabetes medication over previous three months * Ability to provide informed consent
Exclusion criteria
* alcohol consumption \>20g/day (women) or \>30g/day (men) * alternate etiology for abnormal liver enzymes * decompensated liver disease * use of orlistat, liraglutide, prebiotic, probiotic, or antibiotic within 3 months prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histological change | 9 months | Nonalcoholic fatty liver disease activity score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 9 months | Body weight measurement |
| Glucose tolerance | 9 months | Oral glucose tolerance test |
| Gut microbiota | 9 months | Intestinal microbiota composition |
| Serum total cholesterol | 9 months | Total cholesterol |
| Body composition | 9 months | Body lean and fat mass |
| Serum triglycerides | 9 months | Triglycerides |
| Serum HDL cholesterol | 9 months | High-density lipoprotein cholesterol |
| Serum IL-6 | 9 months | Interleukin-6 |
| Serum TNF-alpha | 9 months | Tumor necrosis factor - alpha |
| Serum LDL cholesterol | 9 months | Low-density lipoprotein cholesterol |
Outcome results
None listed