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Completed

NCT Number: NCT01857258

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

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.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green Tea Concentrate

Dietary Supplement

Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose

Primary outcomes

  1. 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.

  2. 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.

  3. Brachial Artery Flow-mediated Dilation

    Time frame: 0 min (baseline)

  4. Brachial Artery Flow-mediated Dilation

    Time frame: 60 min

Secondary outcomes

  1. Malondialdehyde (0 Min)

    Time frame: Baseline (0 min)

  2. Malondialdehyde

    Time frame: 60 min postprandially

  3. Ratio of Asymmetric Dimethylarginine Relative to Arginine

    Time frame: 0 min (baseline)

  4. Ratio of Asymmetric Dimethylarginine Relative to Arginine

    Time frame: 60 min (baseline)

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
May 20, 2013
Registry last updated
Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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