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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
14
Powder format
Powder format
Histological change
Nonalcoholic fatty liver disease activity score
Time frame: 9 months
Body composition
Body lean and fat mass
Time frame: 9 months
Body weight
Body weight measurement
Time frame: 9 months
Glucose tolerance
Oral glucose tolerance test
Time frame: 9 months
Gut microbiota
Intestinal microbiota composition
Time frame: 9 months
Serum total cholesterol
Total cholesterol
Time frame: 9 months
Serum LDL cholesterol
Low-density lipoprotein cholesterol
Time frame: 9 months
Serum triglycerides
Triglycerides
Time frame: 9 months
Serum HDL cholesterol
High-density lipoprotein cholesterol
Time frame: 9 months
Serum IL-6
Interleukin-6
Time frame: 9 months
Serum TNF-alpha
Tumor necrosis factor - alpha
Time frame: 9 months
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