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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-04-30

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.

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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.

Conditions

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Hyperglycemia Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Green Tea

Participants will be provided a confection containing green tea concentrate

Group Type EXPERIMENTAL

Green Tea Concentrate

Intervention Type DIETARY_SUPPLEMENT

Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose

Control

Participants will be provided a confection devoid of green tea concentrate

Group Type ACTIVE_COMPARATOR

Green Tea Concentrate

Intervention Type DIETARY_SUPPLEMENT

Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose

Interventions

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Green Tea Concentrate

Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose

Intervention Type DIETARY_SUPPLEMENT

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