NCT01341769撤回不适用
A Study to Determine the Effects of Added Ingredients on Glycaemic and Insulinemic Responses to a Snack Food
Mondelēz International, Inc.1 个研究点 分布在 1 个国家开始时间: 2011年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Glycaemic index of experimental test foods compared to that of control test food using venous plasma.
研究概览
简要总结
The purpose of this study is to assess the effects of added food ingredients, when baked into a snack food product, on glycaemic index of the product and glycaemic and insulinemic responses to the product in healthy adults.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female (not less than 40% males or females
- •Non-smoker
- •Aged 18 to 55 years
- •Have a body mass index between 18.5 to 29.99 kg/m2
- •Fasting blood glucose (finger-stick) >3.3 and <5.6 mmol/L (Visit 2)
- •Two-hour OGTT glucose (finger-stick) <7.8 mmol/L (Visit 2)
- •Willing and able to provide written informed consent
排除标准
- •Females who are lactating or may be pregnant or if of childbearing potential, are not taking adequate contraceptive precautions
- •Any significant concurrent illness
- •History of allergy likely to interfere with the study or known sensitivity to the test food or its ingredients
- •Have assessed an investigational product for GI in the last 72 hours.
- •Concurrent participation in any other safety study
- •History of diabetes, hepatitis, AIDS, anaemia or a heart condition
- •The use of any medication or dietary supplement which might, in the opinion of the principal investigator 1) make participation in the study dangerous to the subject, or 2) may affect the results.
- •Had any type of gastrointestinal surgery, including gastric bypass
- •Having consumed anything apart from plain water in the 12 hours prior to each test
- •Have been medically diagnosed as having high blood pressure or heart disease
研究组 & 干预措施
Control Test Food
Placebo Comparator
Snack base
干预措施: Dietary Intervention (Other)
Experimental Test Food 1
Experimental
Snack Base containing ingredient 1
干预措施: Dietary Intervention (Other)
Experimental Test Food 2
Experimental
Snack base containing ingredient 2
干预措施: Dietary Intervention (Other)
Experimental Test Food 3
Experimental
Snack base containing ingredients 1 and 2
干预措施: Dietary Intervention (Other)
结局指标
主要结局
Glycaemic index of experimental test foods compared to that of control test food using venous plasma.
时间窗: 0-120 minutes
次要结局
- Glycaemic index of experimental test foods compared to that of control test food using capillary blood(0-120 minutes)
- Determine and compare glycaemic responses to experimental test foods and control test food using venous plasma and capillary blood(0-180 minutes)
- Measure C-peptide in venous plasma(0-180 minutes)
- Measure insulin in venous plasma(0-180 minutes)
研究者
研究点 (1)
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