Effect of Tea Extract on Post Prandial Blood Glucose
This study is designed as a randomized, single blind (data evaluation), placebo controlled, full cross-over study and conducted in 166 (including 10% drop out) males and females, aged ≥ 18 and ≤ 65 and waist circumference of >80 cm for women and >94 cm for men (indicating increased risk of metabolic complications (WHO)) and having a sedentary lifestyle. Subjects will receive rice with a tea extract and rice without a tea extract.
There will be three visits to the test facility: one screening visit and two intervention visits. During the intervention visits venous blood samples will be collected for the analysis of plasma glucose (t = -30m, -5m, 15m, 30m, 45m, 1h, 1h 30m, 2h and 3h, relative to the start of rice consumption ) and serum insulin (t = -5m, 30m, 1h, 2h and 3h).
Between the two intervention visits subjects have an interval of one week. This interval is required to minimize subject discomfort from repeated blood sampling.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Cork、爱尔兰、T12 H2TK
- Atlantia Food Clinical Trials
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Waist circumference > 80 cm for women and > 94 cm for men;
- Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases);
- Fasting blood glucose value of subjects is ≥ 3.4 and <6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening;
- Being physically inactive (meaning less than five times 30 minutes of moderate activity per week, or less than three times 20 minutes of vigorous activity per week, or equivalent);
Exclusion Criteria:
- Use of antibiotics within 3 months before first intake of test product;
- Use of any other medication except paracetamol, within 14 days before first intake of test product;
- Consumption of > 14 units (female subjects) and > 21 units (male subjects) alcoholic drinks in a typical week;
- Dislike, known allergy or intolerance to the treatments or other food products provided during the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Tea extract
Rice with tea extract
|
Rice with tea extract
|
|
安慰剂比较：No tea extract
Rice without tea extract
|
Rice without tea extract
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Incremental area under the plasma glucose versus time curve
大体时间：0-2 hours
|
0-2 hours
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Incremental area under the plasma glucose versus time curve
大体时间：0-3 hours
|
0-3 hours
|
|
Maximum venous glucose concentration
大体时间：0-3 hours
|
0-3 hours
|
|
Total area under the post prandial insulin versus time curves
大体时间：0-2 hours
|
0-2 hours
|
|
Total area under the post prandial insulin versus time curves
大体时间：0-3 hours
|
0-3 hours
|
合作者和调查者
赞助
调查人员
- 首席研究员：Fergus Shanahan, Prof、Consultant gastroenterologist
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.