NCT02037854Unknown不适用
PEP-1324: Glycemic Response Testing
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Incremental area under the blood glucose response cruve
研究概览
简要总结
The purpose of this study is to assess whether food ingredient(s) affect glycemic and insulinemic responses.
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
- Double (Participant, Investigator)
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
- •Subject is 18-75 years of age
- •Subject is male or non-pregnant females, 18-75 years of age, inclusive
- •Subject has a body mass index (BMI) ≥ 20.0 and < 35 kg/m² at screening (visit 1).
- •Subject has to be non-smoker.
- •Subject is willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- •Subject is willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
- •Subject has normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
- •Subject is willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
- •Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Investigator on the basis of medical history.
- •Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
A nutrient formulation without the active ingredient
干预措施: Nutrient formulation (Other)
Nutrient formulation
Experimental
Nutrient formulations with variable amounts of active ingredients.
干预措施: Nutrient formulation (Other)
结局指标
主要结局
Incremental area under the blood glucose response cruve
时间窗: 0-2 hours
次要结局
- peak insulin(0-2 hours)
- peak blood glucose(0-2 hours)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Glycemic Response TestingGlycemic ResponseNCT02020798PepsiCo Global R&D38
已完成
不适用
Glycaemic Response TestingGlycaemic IndexGlycaemic ResponseNCT01536847Mondelēz International, Inc.12
已完成
不适用
Glycemic Response TestingGlycemic IndexGlycemic ResponseNCT01536860Mondelēz International, Inc.12
已完成
不适用
Glycemic Index and Glycemic Response of Food and ProductsHealthyNCT01660074National Pingtung University Science and Technology10
已完成
不适用
A Study to Evaluate Glucose and Insulin Response to NutralinDiabetesNCT01275820Avera McKennan Hospital & University Health Center10