Metabolic Effects of Short Term Sugarcane Bagasse Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- The benefit of sugarcane bagasse on glucose tolerance and insulin resistance in adults with established insulin resistance
研究概览
简要总结
The purpose of this study is to help understand the benefits of eating food supplemented with fiber in the form of sugarcane bagasse (the leftover fiber after cane juice is extracted) on glucose metabolism and body weight.
详细描述
The investigators will employ a double-blind randomized controlled study design with 3 arms such that obese, insulin resistant adults will be randomly selected to receive food made with 1) sugarcane bagasse, 2) non-caloric, non-fermentable fiber, or 3) a similar product with minimal fiber for 4 weeks. The intervention will be in the form of brownies and cookies and will look and taste nearly identical to each other. Caloric value will be constant with all three delivery systems. Subjects will have blood testing and body composition analysis before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females age 18-50 years
- •Body Mass Index ≥ 30 kg/m2 (a ratio of weight to height)
- •Fasting insulin level >5 µIU/mL, as determined by tests performed during screening
排除标准
- •Women who are pregnant
- •Past medical history of diabetes
- •History of intestinal surgery such as removal of bowel
- •History of problems with absorbing food such as celiac disease, inflammatory bowel disease, malabsorption syndrome
- •Taking chronic medications for any medical conditions such as diabetes, hypertension, cholesterol, thyroid hormone, etc.
- •Any food allergies
结局指标
主要结局
The benefit of sugarcane bagasse on glucose tolerance and insulin resistance in adults with established insulin resistance
时间窗: 4 weeks
Participants will be randomly selected to eat food supplemented with either 1) sugarcane bagasse, 2) another type of fiber of equal weight, or 3) minimal fiber. At baseline each eligible subject will have a 3 hour oral glucose tolerance test. Subjects will consume one brownie and two cookies a day for four weeks. At the end of four weeks, the blood tests conducted at baseline will be repeated.
次要结局
- The effect of sugarcane bagasse on body weight/composition(4 weeks)
研究者
Daniel Hsia
Principal Investigator
Pennington Biomedical Research Center