Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Change in baseline fat mass at 12 weeks
研究概览
简要总结
The metabolic syndrome is rising worldwide as a consequence of the continued obesity epidemic. The current obesogenic environment makes the regulation of energy intake difficult and impedes the maintenance of weight loss. Dietary patterns and/or ingredients that curb hunger and reduce energy intake are critically needed. We hypothesize that inclusion of protein and prebiotic fiber in the diet will reduce adiposity in overweight and obesity adults.
详细描述
The main objective of our study is to assess the effects of protein and prebiotic fiber intake on changes in adiposity in an overweight and obese adult population.
Primary objective - To determine the effect of 12 week protein (10 g/day) or prebiotic fiber (16 g/day) intake on changes in body composition, chiefly body fat.
Secondary objective - To measure changes in appetite following 12 weeks of protein (10 g/day) or prebiotic fiber (16 g/day) intake.
Other outcomes includes changes in quality of life ratings and gut microbiota.
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 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
- •Type 1 diabetes
- •Clinically significant cardiovascular, liver or pancreas disease
- •Major gastrointestinal surgeries
- •Pregnant or lactating
- •Concomitant use of any weight loss medication, diet or exercise regime
- •Antibiotic use in the preceding 3 months to enrollment
- •Weight loss > 3 kg within preceding 3 months to enrollment
- •Use of bulk laxatives, fiber supplements or probiotic/prebiotic supplements
结局指标
主要结局
Change in baseline fat mass at 12 weeks
时间窗: 12 weeks
Assessed with dual energy x-ray absorptiometry.
次要结局
- Change in baseline appetite at 12 weeks(12 weeks)
研究者
Dr. Raylene Reimer
Professor
University of Calgary