NCT00888602已完成不适用
An Open Label, Randomized, 4-Period Cross-over Study to Evaluate the Effects of Psyllium Taken Before a Meal on Postprandial Blood Glucose in Healthy Males
Procter and Gamble2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2009年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- to evaluate the effect of 2 dosing levels of psyllium on glucose in blood when taken prior to a meal vs. a meal alone
研究概览
简要总结
This is an open label, single use, randomized, 4-period cross-over study. In each period, subjects will receive one of 4 test combinations. Blood will be drawn prior to study product consumption and following study product consumption for glucose measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 to 50 years of age
- •general good health
- •Body Mass Index (BMI) in the range of 18.5-29.9 kg/m2
- •fasting plasma blood glucose <126mg/dL
- •not actively treated for high blood glucose
- •willing and able to have blood drawn at multiple times during each 4 visits
排除标准
- •history of allergy or hypersensitivity to inhaled or ingested psyllium or meal ingredients
- •Phenylketonuria (PKU)
- •an eating disorder
- •following special medical or weight-loss dietary restrictions
- •taking dietary supplements or prescription medication for the purpose of weight loss/management
结局指标
主要结局
to evaluate the effect of 2 dosing levels of psyllium on glucose in blood when taken prior to a meal vs. a meal alone
时间窗: 4 hours
次要结局
未报告次要终点
研究者
研究点 (2)
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