Histological Improvement of Non-alcoholic Steatohepatitis With a Prebiotic: a Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- Histological change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Histological change
时间窗: 9 months
Nonalcoholic fatty liver disease activity score
次要结局
- Body composition(9 months)
- Glucose tolerance(9 months)
- Serum TNF-alpha(9 months)
- Serum triglycerides(9 months)
- Serum total cholesterol(9 months)
- Gut microbiota(9 months)
- Serum LDL cholesterol(9 months)
- Body weight(9 months)
- Serum HDL cholesterol(9 months)
- Serum IL-6(9 months)
研究者
Dr. Raylene Reimer
Professor
University of Calgary