Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
- Conditions
- Cardiovascular DiseaseHyperglycemia
- Interventions
- Dietary Supplement: Green Tea Concentrate
- Registration Number
- NCT01857258
- Lead Sponsor
- Ohio State University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
- 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
- allergies or aversions to green tea and/or corn starch,
- excessive alcohol consumption (>3 drinks/d),
- >5 h/wk of aerobic activity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Green Tea Green Tea Concentrate Participants will be provided a confection containing green tea concentrate Control Green Tea Concentrate Participants will be provided a confection devoid of green tea concentrate
- Primary Outcome Measures
Name Time Method Area Under the Curve of Blood Glucose 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 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 60 min
- Secondary Outcome Measures
Name Time Method Malondialdehyde (0 Min) Baseline (0 min) Malondialdehyde 60 min postprandially Ratio of Asymmetric Dimethylarginine Relative to Arginine 60 min (baseline)
Trial Locations
- Locations (1)
The Ohio State University
🇺🇸Columbus, Ohio, United States
The Ohio State University🇺🇸Columbus, Ohio, United States