The Effect of Starch Processing on Postprandial Blood Glucose in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Postprandial Glycemia
研究概览
简要总结
The goal of this clinical trial is to determine the postprandial glycemic response of the two starches in humans. Participants will be asked to consume 2 test foods on 2 separate occasions and provide blood glucose samples over 120 minutes postprandial.
详细描述
Enrolled participants who are generally healthy and free of major chronic conditions will be randomized to receive either Commercial Native Starch or Extrusion Processed Starch first and then will be crossed over to receive the opposite Intervention. The study will consist of two clinical test visits of 120 minutes separated by a washout period of at least 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult males or non-pregnant females.
- •eligible to receive income in Canada.
排除标准
- •age less than 18 years
- •any known food allergies or intolerances to the investigational product
- •medications known to affect glucose tolerance -but stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable
- •known history of diabetes mellitus or the use of anti-hyperglycemic drugs or insulin to treat diabetes and related conditions
- •any major medical or surgical events requiring hospitalization within the preceding 3 months
- •the presence of disease or drug(s) which influence digestion and absorption of nutrients
- •the short-term use of systemic steroids or atypical antipsychotics (<4 weeks) (all of which have major effects on glucose and metabolism and body fat distribution)
- •any other medications or conditions which might, in the opinion of the Medical Director of INQUIS Clinical Research Ltd. (INQUIS), either 1) make participation dangerous to the subject or to others, or 2) affect the results
- •any subject who cannot or will not comply with the experimental procedures or do not follow INQUIS safety guidelines
结局指标
主要结局
Postprandial Glycemia
时间窗: -5 to 120 minutes after intervention administration
Incremental area under the curve for blood glucose over 120 minutes.
次要结局
- Incremental Blood Glucose(0, 15, 30, 45, 60, 90, and 120 minutes after intervention administration)