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OpenTrials
Completed

NCT Number: NCT03184376

Histological Improvement of NASH With Prebiotic

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prebiotic oligofructose

Dietary Supplement

Powder format

Placebo Maltodextrin

Dietary Supplement

Powder format

Primary outcomes

  1. Histological change

    Time frame: 9 months

    Nonalcoholic fatty liver disease activity score

Secondary outcomes

  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

    Triglycerides

  8. Serum HDL cholesterol

    Time frame: 9 months

    High-density lipoprotein cholesterol

  9. Serum IL-6

    Time frame: 9 months

    Interleukin-6

  10. Serum TNF-alpha

    Time frame: 9 months

    Tumor necrosis factor - alpha

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

Histological Improvement of Non-alcoholic Steatohepatitis With a Prebiotic: a Pilot Clinical Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jun 12, 2017
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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