Evaluation of Pulse Fibre Supplementation in Obesity and the Metabolic Syndrome: Generating Evidence in Support of Health Claims
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Change in Fat Mass at 12 Weeks
研究概览
简要总结
The recent dramatic increase in obesity has been linked to a reduction of dietary fibre intake. We hypothesized that supplementing the diet of overweight and obesity adults with pulse fibre will improve their metabolic status, chiefly defined as greater weight loss. Other metabolic health improvements may include improved glucose control and reduced inflammatory markers.
详细描述
The main objective of our study is to assess the effects of pulse fibre supplementation on weight loss in an overweight and obese adult population.
Primary objective - To determine the effects of a 12 week intake of 15g/day of pea hull fibre on weight loss supported by body composition measures.
Secondary objective - To measure glucose control and appetite regulation in overweight and obese adults consuming 15g/day of pea hull fibre compared to a placebo control with the use of plasma HbA1c and an oral glucose tolerance test (OGTT).
Tertiary objective - To examine mechanisms of action of pulse fibre supplementation by determining the impact of pulse fibre supplementation on gut microbiota, serum metabolomics and fecal short-chain fatty acid and bile acid concentrations.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females
- •Age 18 - 70 years
- •BMI 25 - 38 kg/m-2
- •Stable body weight for at least 3 months prior to the study
排除标准
- •Concomitant use of any weight loss medication, diet or exercise regime
- •Use of corticosteroids, anti-depressants, anti-epileptic medications, lipid lowering medication, diabetes medications
- •Previous bariatric or other intestinal surgeries
- •Pregnancy or lactation
- •Weight loss > 3 kg within preceding 3 months to enrollment
- •Use of bulk laxatives or probiotics/prebiotics supplements
- •Antibiotic use in the past month
- •Clinically significant cardiovascular or respiratory or liver disease
结局指标
主要结局
Change in Fat Mass at 12 Weeks
时间窗: Value at 12 weeks minus value at baseline
Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.
次要结局
- HbA1c at 12 Weeks(12 weeks)
- Change in Objective Appetite at 12 Weeks(12 weeks minus baseline)
研究者
Dr. Raylene Reimer
Professor, Faculty of Kinesiology
University of Calgary