Histological Improvement of NASH With Prebiotic

University of Calgary

Status: Completed

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Dietary Supplement: Placebo maltodextrin; Dietary Supplement: Prebiotic oligofructose

Study type: Interventional

Funder types: Other

Identifiers

NCT03184376

E-23936

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups, including a placebo group

Prebiotic

Experimental group

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.

Treatment:

Dietary Supplement: Prebiotic oligofructose

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo maltodextrin