Clinical trial NCT03184376: Histological Improvement of NASH With Prebiotic
Official title: Histological Improvement of Non-alcoholic Steatohepatitis With a Prebiotic: a Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Gut microbiota
Prebiotic
Liver biopsy
Oligofructose
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, placebo controlled, randomized trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Histological change
timeFrame: 9 months
Secondary outcomes:
measure: Body composition
timeFrame: 9 months
measure: Body weight
timeFrame: 9 months
measure: Glucose tolerance
timeFrame: 9 months
measure: Gut microbiota
timeFrame: 9 months
measure: Serum total cholesterol
timeFrame: 9 months
measure: Serum LDL cholesterol
timeFrame: 9 months
measure: Serum triglycerides
timeFrame: 9 months
measure: Serum HDL cholesterol
timeFrame: 9 months
measure: Serum IL-6
timeFrame: 9 months
measure: Serum TNF-alpha
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
affiliation: The University of Calgary
name: Raylene A Reimer, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.