NCT01671878已完成不适用
Characterization of the Postprandial Glucose and Insulin Responses to Test Foods in Lean and Overweight Subjects
Mondelēz International, Inc.2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年9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
- 12
- 试验地点
- 2
- 主要终点
- Postprandial Glucose Response
研究概览
简要总结
In this study, postprandial glucose and insulin responses of different foods will be measured in individuals with varying body weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be non-smoking males or non-pregnant females aged 20-45y, with normal glycemia and in good health. A total of 12 participants will be included, where approximately half will be male & half female, and half normal weight (BMI > 19.0 and < 25.0) and half overweight but not obese (BMI > 25.0 and < 30). Thus, no fewer than 5 male, 5 female, 5 normal weight and 5 overweight but not obese subjects will be included. Additional inclusion criteria will include:
- •Absence of diabetes, impaired glucose tolerance and impaired fasting glucose, defined as having a fasting plasma glucose < 5.6 mmol/L (100 mg/dL) AND plasma glucose levels < 7.8 mmol/L (140 mg/dL) 2h after consumption of a 50 g glucose drink (OGTT will be administered during the screening visit)
- •Systolic blood pressure 100-150 mmHg inclusive
- •Diastolic blood pressure 60-90 mmHg inclusive
- •Resting heart rate 50-90 beats/min inclusive after 3 minute rest
- •Able to refrain from eating legumes and drinking alcohol the day before each test session
- •Fasting triglycerides < 2.0 mmol/L (178 mg/dL)
- •Fasting HDL cholesterol > 0.9 mmol/L (35 mg/dL) for males and > 1.1mmol/L (42 mg/dL) for females
- •Fasting LDL cholesterol < 5.0 mmol/L (193 mg/dL)
- •AST and ALT < 120% of upper limit of normal (ULN)
- •hsCRP < 10 mg/L
- •Urea and creatinine < 150% ULN
排除标准
- •failure to meet any one of the inclusion criteria
- •age less than 18 or over 45 years
- •known history or AIDS, hepatitis, diabetes or a heart condition
- •participants using medications or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results
- •participants who cannot or will not comply with the experimental procedures or do not follow GI Labs safety guidelines.
- •Food allergies of any kind
- •General anaesthesia in the month prior to inclusion.
结局指标
主要结局
Postprandial Glucose Response
时间窗: 3 hours
次要结局
- Postprandial Insulin Response(3 hours)
研究者
研究点 (2)
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