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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Cardiovascular Disease
• Intervention / Treatment: Dietary supplement: Green Tea Concentrate

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: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve of Blood Glucose	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, 0, 30, 60, 90, 120, 150, 180 minutes post-dose
Area Under the Curve of Brachial Artery Flow Mediated Dilatiion	Brachial artery flow-mediated dilation will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes following the ingestion of a confection.	Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose
Brachial Artery Flow-mediated Dilation		0 min (baseline)
Brachial Artery Flow-mediated Dilation		60 min

Secondary Outcome Measures

Outcome Measure	Time Frame
Malondialdehyde (0 Min)	Baseline (0 min)
Malondialdehyde	60 min postprandially
Ratio of Asymmetric Dimethylarginine Relative to Arginine	0 min (baseline)
Ratio of Asymmetric Dimethylarginine Relative to Arginine	60 min (baseline)

Collaborators and Investigators

• Sponsor: Ohio State University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 16, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimate): May 20, 2013

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: oxidative stress; green tea; catechins; vascular endothelial function; postprandial hyperglycemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Cardiovascular Diseases
• Other Study ID Numbers: 2013H0116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes