NCT05870891已完成不适用
Equivalent Glycemic Load and Insulinemic Response Elicited by 7 Low Carbohydrate Products in Healthy Adults
General Mills2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年6月15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
- 25
- 试验地点
- 2
- 主要终点
- Equivalent glycemic load
研究概览
简要总结
The purpose of this study is to test the hypothesis that the equivalent glycemic load (EGL) value of portions of white bread containing 5 g available carbohydrate measured in this study is accurate and precise to within 1 gram. Additionally, the EGL of 7 low carbohydrate foods will be measured to determine their glycemic impact.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-75 inclusive
- •Willing to abstain from unusual strenuous exercise and consuming alcoholic drinks for 24 hours before study days
- •Willing to refrain from smoking tobacco or marijuana for 12h before and during study visits
- •Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator
- •Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP
排除标准
- •Failure to meet any one of the inclusion criteria at screening
- •Pregnant or lactating individuals
- •Personal history of diabetes
- •Major trauma or surgical event within 3 months of screening
- •The presence of any laboratory result, health condition, illness or drug use that increases risk to the subject or to others or may affect the results, as judged by the Qualified Investigator
- •Unwillingness or inability to comply with experimental procedures and to follow INQUIS safety guidelines
- •Known intolerance, sensitivity, or allergy to any ingredients in the study test meals. All allergens should be assumed to be a result of manufacturing practices.
- •Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement or lifestyle modification
结局指标
主要结局
Equivalent glycemic load
时间窗: -5 minutes to 120 minutes
Equivalent glycemic load (EGL) for each test food, expressed as \[EGL = T/(W/Cwb)\] where T is the plasma glucose incremental area under the curve over 120 minutes (iAUC) elicited by one serving of test food, W is the mean iAUC elicited by the mean of two WB20 tests and Cwb is the amount of available carbohydrate in the WB20.
次要结局
- Insulin iAUC over 120 minutes(-5 minutes to 120 minutes)
- Glucose iAUC over 120 minutes(-5 minutes to 120 minutes)
研究者
研究点 (2)
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