NCT03184376

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

3.8 years

First QC Date

June 8, 2017

Last Update Submit

June 9, 2017

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Gut microbiotaPrebioticLiver biopsyOligofructose

Outcome Measures

Primary Outcomes (1)

  • Histological change

    Nonalcoholic fatty liver disease activity score

    9 months

Secondary Outcomes (10)

  • Body composition

    9 months

  • Body weight

    9 months

  • Glucose tolerance

    9 months

  • Gut microbiota

    9 months

  • Serum total cholesterol

    9 months

  • +5 more secondary outcomes

Study Arms (2)

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.

Dietary Supplement: Prebiotic oligofructose

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.

Dietary Supplement: Placebo maltodextrin

Interventions

Prebiotic oligofructoseDIETARY_SUPPLEMENT

Powder format

Prebiotic
Placebo maltodextrinDIETARY_SUPPLEMENT

Powder format

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29779170DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Raylene A Reimer, PhD, RD

    The University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-blind, placebo controlled, randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 8, 2017

First Posted

June 12, 2017

Study Start

February 28, 2012

Primary Completion

December 16, 2015

Study Completion

May 30, 2016

Last Updated

June 12, 2017

Record last verified: 2017-06