Prebiotic Fibre Supplementation and Gut Microbiota in Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in Liver Fat
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) is a condition where accumulation of fat in the liver leads to metabolic dysfunction. Currently there are no approved treatments for NAFLD. Part of the metabolic dysfunction may arise through changes in the gut microbiota. Prebiotic fibres have beneficial effects on glucose tolerance, body weight, and gut microbiota; therefore they may have potential as part of a dietary strategy for NAFLD treatment.
详细描述
The main objective of this study is to assess the effect of prebiotic fibre supplementation, in conjunction with diet-induced weight loss, on reduction in liver fat and injury.
Primary Objective - determine the change in hepatic injury (fibrosis and inflammation) and hepatic fat (percent fat) over 6 months in NAFLD patients treated with prebiotic or placebo during weight loss.
Secondary Objectives - determine the changes in appetite, body composition, glycemic and insulinemic responses, quality of life with prebiotic or placebo during weight loss, and examine mechanisms related to prebiotic-induced changes in gut microbiota and lipogenesis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects diagnosed with NAFLD on the basis of abnormal liver enzymes (ALT>1.5x upper limit of normal) and ultrasonography
- •Exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease
- •Aspartate aminotransferase and alanine aminotransferase ≤10x upper limit of normal
- •Patients with type 2 diabetes treated with diet and exercise alone or metformin
排除标准
- •Cirrhosis of the liver (FibroScan >17.5 kilopascal or FibroTest >0.8) or clinical features of cirrhosis.
- •Alcohol consumption >20g/day (2 standard drinks) in women or > 30g/d (3 drinks) in men
- •Alternate (e.g. TPN) or concomitant etiology for abnormal liver enzymes.
- •History of decompensated liver disease including ascites, encephalopathy or variceal bleeding
- •Concomitant use of any weight loss medication, previous bariatric or other intestinal surgery
- •Presence of active infection, pregnancy or lactation
- •Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment
- •Antibiotic use within 3 months prior to enrollment
- •Weight loss >3 kg within preceding 3 months to enrollment
- •Uncontrolled cardiovascular or respiratory disease, active malignancy, or chronic infections
- •Use of agents such as vitamin E, omega-3 fatty acids or medications with evidence for effects on NAFLD (pioglitazone, Glucagon-like peptide-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid)
- •Patients with type 2 diabetes where HbA1c is >9%
结局指标
主要结局
Change in Liver Fat
时间窗: 24 weeks
Assessed via MRI
Change in Liver Fibrosis
时间窗: 24 weeks
Assessed via FibroScan (transient elastography)
Change in Liver Injury
时间窗: 24 weeks
Assessed via Fibrotest Score (composite score from serum biochemical markers: alfa2-macroglobulin, apolipoproteinA1, total bilirubin, haptoglobin, gamma glutamyl transpeptidase, alanine aminotransferase)
次要结局
- Change in Glucose Tolerance(24 weeks)
- Dietary Adherence(24 weeks)
- Change in Subjective Appetite(24 weeks)
- Change in Satiety Hormones(24 weeks)
- Change in Quality of Life(24 weeks)
- Change in Glycemic Control(24 weeks)
- Change in Body Composition(24 weeks)
- Examine mechanisms related to prebiotic-induced changes in gut microbiota, their metabolic byproducts, and de novo lipogenesis(24 weeks)
研究者
Raylene Reimer
Professor
University of Calgary