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

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The Ohio State University

Status

Completed

Conditions

Hyperglycemia
Cardiovascular Disease

Treatments

Dietary Supplement: Green Tea Concentrate

Study type

Interventional

Funder types

Other

Identifiers

NCT01857258
2013H0116

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

Male

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

15 participants in 2 patient groups

Green Tea
Experimental group
Description:
Participants will be provided a confection containing green tea concentrate
Treatment:
Dietary Supplement: Green Tea Concentrate
Control
Active Comparator group
Description:
Participants will be provided a confection devoid of green tea concentrate
Treatment:
Dietary Supplement: Green Tea Concentrate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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