Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction

Conditions
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Hyperglycemia, Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Green Tea Concentrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Green Tea<br>Participants will be provided a confection containing green tea concentrate | Dietary Supplement: Green Tea Concentrate<br>* Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose<br>|
| Active Comparator: Control<br>Participants will be provided a confection devoid of green tea concentrate | Dietary Supplement: Green Tea Concentrate<br>* Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve of Blood Glucose | 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, 0, 30, 60, 90, 120, 150, 180 minutes post-dose | 
| Area Under the Curve of Brachial Artery Flow Mediated Dilatiion | Brachial artery flow-mediated dilation will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes following the ingestion of a confection. | Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose | 
| Brachial Artery Flow-mediated Dilation |  | 0 min (baseline) | 
| Brachial Artery Flow-mediated Dilation |  | 60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malondialdehyde (0 Min) |  | Baseline (0 min) | 
| Malondialdehyde |  | 60 min postprandially | 
| Ratio of Asymmetric Dimethylarginine Relative to Arginine |  | 0 min (baseline) | 
| Ratio of Asymmetric Dimethylarginine Relative to Arginine |  | 60 min (baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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green tea, catechins, vascular endothelial function, postprandial hyperglycemia, oxidative stress