Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
This trial is active, not recruiting.
|Conditions||hyperglycemia, cardiovascular disease|
|Treatment||green tea concentrate|
|Sponsor||Ohio State University|
|Start date||May 2013|
|End date||February 2015|
|Trial size||20 participants|
|Trial identifier||NCT01857258, 2013H0116|
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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
time frame: 3 hours
time frame: 3 hours
Male participants from 18 years up to 30 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - allergies or aversions to green tea and/or corn starch, - excessive alcohol consumption (>3 drinks/d), - >5 h/wk of aerobic activity
|Official title||Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction|
|Principal investigator||Richard Bruno, PhD, RD|
|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.|
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