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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01857258
First Posted: May 20, 2013
Last Update Posted: February 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard Bruno, Ohio State University
  Purpose
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.

Condition Intervention
Hyperglycemia Cardiovascular Disease Dietary Supplement: Green Tea Concentrate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction

Resource links provided by NLM:


Further study details as provided by Richard Bruno, Ohio State University:

Primary Outcome Measures:
  • Area Under the Curve of Blood Glucose [ Time Frame: Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose ]
    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 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 will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes following the ingestion of a confection.

  • Brachial Artery Flow-mediated Dilation [ Time Frame: 0 min (baseline) ]
  • Brachial Artery Flow-mediated Dilation [ Time Frame: 60 min ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 15
Study Start Date: May 2013
Study Completion Date: April 2016
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Green Tea
Participants will be provided a confection containing green tea concentrate
Dietary Supplement: Green Tea Concentrate
Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose
Active Comparator: Control
Participants will be provided a confection devoid of green tea concentrate
Dietary Supplement: Green Tea Concentrate
Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857258


Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Richard Bruno, PhD, RD Ohio State University
  More Information

Publications:
Responsible Party: Richard Bruno, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01857258     History of Changes
Other Study ID Numbers: 2013H0116
First Submitted: May 16, 2013
First Posted: May 20, 2013
Results First Submitted: September 30, 2016
Results First Posted: February 16, 2017
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Richard Bruno, Ohio State University:
green tea
catechins
vascular endothelial function
postprandial hyperglycemia
oxidative stress

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases