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

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.
 
ClinicalTrials.gov Identifier: NCT01857258
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Richard Bruno, Ohio State University

Tracking Information
First Submitted Date  ICMJE May 16, 2013
First Posted Date  ICMJE May 20, 2013
Results First Submitted Date  ICMJE September 30, 2016
Results First Posted Date  ICMJE February 16, 2017
Last Update Posted Date February 16, 2017
Study Start Date  ICMJE May 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
Postprandial Glycemia [ Time Frame: 3 hours ]
Blood glucose will be measured at regular intervals throughout a 3 hour postprandial period following the ingestion of a confection.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
Vascular Function [ Time Frame: 3 hours ]
Brachial artery flow-mediated dilation will be measured at regular intervals throughout a 3 hour postprandial period following the ingestion of a confection.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
Official Title  ICMJE Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Hyperglycemia
  • Cardiovascular Disease
Intervention  ICMJE Dietary Supplement: Green Tea Concentrate
Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose
Study Arms  ICMJE
  • Experimental: Green Tea
    Participants will be provided a confection containing green tea concentrate
    Intervention: Dietary Supplement: Green Tea Concentrate
  • Active Comparator: Control
    Participants will be provided a confection devoid of green tea concentrate
    Intervention: Dietary Supplement: Green Tea Concentrate
Publications * Sapper TN, Mah E, Ahn-Jarvis J, McDonald JD, Chitchumroonchokchai C, Reverri EJ, Vodovotz Y, Bruno RS. A green tea-containing starch confection increases plasma catechins without protecting against postprandial impairments in vascular function in normoglycemic adults. Food Funct. 2016 Sep 14;7(9):3843-53. doi: 10.1039/c6fo00639f. Epub 2016 Aug 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2017)
15
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2013)
20
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01857258
Other Study ID Numbers  ICMJE 2013H0116
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Richard Bruno, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Bruno, PhD, RD Ohio State University
PRS Account Ohio State University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP