Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Area Under the Curve of Blood Glucose
研究概览
简要总结
The objective of this study is to formulate and validate a green tea confection (i.e. "gummy" candy) as a strategy to attenuate postprandial hyperglycemia-induced impairments in vascular function. The central hypothesis is that a green tea confection will protect against vascular endothelial dysfunction by suppressing postprandial hyperglycemia. The central hypothesis of this application will be assessed by developing a green tea-containing confection, examining its physiochemical properties and its inhibition of starch digestion, and then validating its vasoprotective activities in healthy humans by assessing its blood glucose-regulating activities.
详细描述
The study involves validating a green tea confection (i.e. "gummy" candy) as a dietary strategy to attenuate postprandial hyperglycemia-induced impairments in vascular function. The central hypothesis is that a green tea confection will protect against vascular endothelial dysfunction by suppressing postprandial hyperglycemia. The central hypothesis of this application will be assessed by providing research participants 75 grams of carbohydrate in the form of a confection that contains no green tea concentrate or green tea concentrate at a level equivalent to approximately 3 cups of freshly brewed tea. Blood glucose and brachial artery flow-mediated dilation will be assessed at regular intervals during the 3 hour postprandial period to define the extent to which green tea attenuates postprandial increases in blood glucose and decreases in vascular function that otherwise occur in a hyperglycemia-dependent manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Plasma glucose <100 mg/dL
- •Plasma total cholesterol <200 mg/dL
- •Plasma triglycerides <140 mg/dL
- •Blood pressure <140/90
- •non-dietary supplement user for >2 months
- •no use of medications known to affect carbohydrate metabolism,
- •nonsmoker / never smoker
- •no history of cardiovascular disease or gastrointestinal disorders
排除标准
- •allergies or aversions to green tea and/or corn starch,
- •excessive alcohol consumption (>3 drinks/d),
- •>5 h/wk of aerobic activity
研究组 & 干预措施
Green Tea
Participants will be provided a confection containing green tea concentrate
干预措施: Green Tea Concentrate (Dietary Supplement)
Control
Participants will be provided a confection devoid of green tea concentrate
干预措施: Green Tea Concentrate (Dietary Supplement)
结局指标
主要结局
Area Under the Curve of Blood Glucose
时间窗: Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose
Blood glucose will be measured at 0, 30, 60, 90, 120, 150 and 180 minutes following the ingestion of a confection to calculate area under the concentration-time curve.
Area Under the Curve of Brachial Artery Flow Mediated Dilatiion
时间窗: Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose
Brachial artery flow-mediated dilation will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes following the ingestion of a confection.
Brachial Artery Flow-mediated Dilation
时间窗: 60 min
Brachial Artery Flow-mediated Dilation
时间窗: 0 min (baseline)
次要结局
- Malondialdehyde (0 Min)(Baseline (0 min))
- Malondialdehyde(60 min postprandially)
- Ratio of Asymmetric Dimethylarginine Relative to Arginine(60 min (baseline))
- Ratio of Asymmetric Dimethylarginine Relative to Arginine(0 min (baseline))
研究者
Richard Bruno
Associate Professor
Ohio State University