Overview

This trial has been completed.

Conditions hyperglycemia, cardiovascular disease
Treatment green tea concentrate
Sponsor Ohio State University
Start date May 2013
End date February 2015
Trial size 15 participants
Trial identifier NCT01857258, 2013H0116

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Primary purpose prevention
Masking participant, investigator, outcomes assessor
Arm
(Experimental)
Participants will be provided a confection containing green tea concentrate
green tea concentrate
Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose
(Active Comparator)
Participants will be provided a confection devoid of green tea concentrate
green tea concentrate
Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose

Primary Outcomes

Measure
Area Under the Curve of Blood Glucose
time frame: Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose
Area Under the Curve of Brachial Artery Flow Mediated Dilatiion
time frame: Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose
Brachial Artery Flow-mediated Dilation
time frame: 0 min (baseline)
Brachial Artery Flow-mediated Dilation
time frame: 60 min

Secondary Outcomes

Measure
Malondialdehyde (0 Min)
time frame: Baseline (0 min)
Malondialdehyde
time frame: 60 min postprandially
Ratio of Asymmetric Dimethylarginine Relative to Arginine
time frame: 0 min (baseline)
Ratio of Asymmetric Dimethylarginine Relative to Arginine
time frame: 60 min (baseline)

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Ohio State University.