Histological Improvement of NASH With Prebiotic

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184376
• Other study ID #: E-23936
• Status: Completed
• Phase: N/A
• First received: June 8, 2017
• Last updated: June 9, 2017
• Start date: February 28, 2012
• Est. completion date: May 30, 2016

Study information

• Verified date: June 2017
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 30, 2016
• Est. primary completion date: December 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Prebiotic oligofructose
Powder format
• Placebo maltodextrin
Powder format

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological change	Nonalcoholic fatty liver disease activity score	9 months
Secondary	Body composition	Body lean and fat mass	9 months
Secondary	Body weight	Body weight measurement	9 months
Secondary	Glucose tolerance	Oral glucose tolerance test	9 months
Secondary	Gut microbiota	Intestinal microbiota composition	9 months
Secondary	Serum total cholesterol	Total cholesterol	9 months
Secondary	Serum LDL cholesterol	Low-density lipoprotein cholesterol	9 months
Secondary	Serum triglycerides	Triglycerides	9 months
Secondary	Serum HDL cholesterol	High-density lipoprotein cholesterol	9 months
Secondary	Serum IL-6	Interleukin-6	9 months
Secondary	Serum TNF-alpha	Tumor necrosis factor - alpha	9 months