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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Richard Bruno, Ohio State University
ClinicalTrials.gov Identifier:
NCT01857258
First received: May 16, 2013
Last updated: August 26, 2014
Last verified: August 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Ohio State University:

Primary Outcome Measures:
  • Postprandial Glycemia [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Blood glucose will be measured at regular intervals throughout a 3 hour postprandial period following the ingestion of a confection.


Secondary Outcome Measures:
  • Vascular Function [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Brachial artery flow-mediated dilation will be measured at regular intervals throughout a 3 hour postprandial period following the ingestion of a confection.


Estimated Enrollment: 20
Study Start Date: May 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   18 Years to 30 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Richard Bruno, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01857258     History of Changes
Other Study ID Numbers: 2013H0116
Study First Received: May 16, 2013
Last Updated: August 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on October 23, 2014