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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857258
• Other study ID #: 2013H0116
• Status: Completed
• Phase: N/A
• First received: May 16, 2013
• Last updated: February 14, 2017
• Start date: May 2013
• Est. completion date: April 2016

Study information

• Verified date: February 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hyperglycemia

Intervention

Dietary Supplement:
• Green Tea Concentrate
Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 normogly — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Brachial Artery Flow-mediated Dilation		0 min (baseline)
Primary	Brachial Artery Flow-mediated Dilation		60 min
Secondary	Malondialdehyde (0 Min)		Baseline (0 min)
Secondary	Malondialdehyde		60 min postprandially
Secondary	Ratio of Asymmetric Dimethylarginine Relative to Arginine		0 min (baseline)
Secondary	Ratio of Asymmetric Dimethylarginine Relative to Arginine		60 min (baseline)