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Histological Improvement of NASH With Prebiotic

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prebiotic oligofructose
Placebo maltodextrin
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Gut microbiota, Prebiotic, Liver biopsy, Oligofructose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Prebiotic

    Placebo

    Arm Description

    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 maltodextrin (isocaloric to prebiotic) taken 3.3g orally per day for 12 weeks followed by 6.6g per day for 24 weeks.

    Outcomes

    Primary Outcome Measures

    Histological change
    Nonalcoholic fatty liver disease activity score

    Secondary Outcome Measures

    Body composition
    Body lean and fat mass
    Body weight
    Body weight measurement
    Glucose tolerance
    Oral glucose tolerance test
    Gut microbiota
    Intestinal microbiota composition
    Serum total cholesterol
    Total cholesterol
    Serum LDL cholesterol
    Low-density lipoprotein cholesterol
    Serum triglycerides
    Triglycerides
    Serum HDL cholesterol
    High-density lipoprotein cholesterol
    Serum IL-6
    Interleukin-6
    Serum TNF-alpha
    Tumor necrosis factor - alpha

    Full Information

    First Posted
    June 8, 2017
    Last Updated
    June 9, 2017
    Sponsor
    University of Calgary
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03184376
    Brief Title
    Histological Improvement of NASH With Prebiotic
    Official Title
    Histological Improvement of Non-alcoholic Steatohepatitis With a Prebiotic: a Pilot Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 28, 2012 (Actual)
    Primary Completion Date
    December 16, 2015 (Actual)
    Study Completion Date
    May 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Calgary

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Alcoholic Fatty Liver Disease
    Keywords
    Gut microbiota, Prebiotic, Liver biopsy, Oligofructose

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Single-blind, placebo controlled, randomized trial
    Masking
    Participant
    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.
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Prebiotic
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo maltodextrin (isocaloric to prebiotic) taken 3.3g orally per day for 12 weeks followed by 6.6g per day for 24 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Prebiotic oligofructose
    Intervention Description
    Powder format
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo maltodextrin
    Intervention Description
    Powder format
    Primary Outcome Measure Information:
    Title
    Histological change
    Description
    Nonalcoholic fatty liver disease activity score
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    Body composition
    Description
    Body lean and fat mass
    Time Frame
    9 months
    Title
    Body weight
    Description
    Body weight measurement
    Time Frame
    9 months
    Title
    Glucose tolerance
    Description
    Oral glucose tolerance test
    Time Frame
    9 months
    Title
    Gut microbiota
    Description
    Intestinal microbiota composition
    Time Frame
    9 months
    Title
    Serum total cholesterol
    Description
    Total cholesterol
    Time Frame
    9 months
    Title
    Serum LDL cholesterol
    Description
    Low-density lipoprotein cholesterol
    Time Frame
    9 months
    Title
    Serum triglycerides
    Description
    Triglycerides
    Time Frame
    9 months
    Title
    Serum HDL cholesterol
    Description
    High-density lipoprotein cholesterol
    Time Frame
    9 months
    Title
    Serum IL-6
    Description
    Interleukin-6
    Time Frame
    9 months
    Title
    Serum TNF-alpha
    Description
    Tumor necrosis factor - alpha
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raylene A Reimer, PhD, RD
    Organizational Affiliation
    The University of Calgary
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Other researchers would need to make an individual inquiry.
    Citations:
    PubMed Identifier
    29779170
    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.
    Results Reference
    derived

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    Histological Improvement of NASH With Prebiotic

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