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Histological Improvement of NASH With Prebiotic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03184376
Recruitment Status : Completed
First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Information provided by (Responsible Party):
Dr. Raylene Reimer, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Dietary Supplement: Prebiotic oligofructose Dietary Supplement: Placebo maltodextrin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-blind, placebo controlled, randomized trial
Masking: Single (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.
Primary Purpose: Treatment
Official Title: Histological Improvement of Non-alcoholic Steatohepatitis With a Prebiotic: a Pilot Clinical Trial
Actual Study Start Date : February 28, 2012
Actual Primary Completion Date : December 16, 2015
Actual Study Completion Date : May 30, 2016

Arm Intervention/treatment
Experimental: Prebiotic
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
Powder format

Placebo Comparator: Placebo
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
Powder format

Primary Outcome Measures :
  1. Histological change [ Time Frame: 9 months ]
    Nonalcoholic fatty liver disease activity score

Secondary Outcome Measures :
  1. Body composition [ Time Frame: 9 months ]
    Body lean and fat mass

  2. Body weight [ Time Frame: 9 months ]
    Body weight measurement

  3. Glucose tolerance [ Time Frame: 9 months ]
    Oral glucose tolerance test

  4. Gut microbiota [ Time Frame: 9 months ]
    Intestinal microbiota composition

  5. Serum total cholesterol [ Time Frame: 9 months ]
    Total cholesterol

  6. Serum LDL cholesterol [ Time Frame: 9 months ]
    Low-density lipoprotein cholesterol

  7. Serum triglycerides [ Time Frame: 9 months ]

  8. Serum HDL cholesterol [ Time Frame: 9 months ]
    High-density lipoprotein cholesterol

  9. Serum IL-6 [ Time Frame: 9 months ]

  10. Serum TNF-alpha [ Time Frame: 9 months ]
    Tumor necrosis factor - alpha

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03184376

Sponsors and Collaborators
University of Calgary
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Principal Investigator: Raylene A Reimer, PhD, RD The University of Calgary

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Raylene Reimer, Professor, University of Calgary Identifier: NCT03184376     History of Changes
Other Study ID Numbers: E-23936
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Other researchers would need to make an individual inquiry.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Raylene Reimer, University of Calgary:
Gut microbiota
Liver biopsy
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases