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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Hyperglycemia
Cardiovascular Disease
Intervention Dietary Supplement: Green Tea Concentrate
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Green Tea First, Then Control Control First, Then Green Tea
Hide Arm/Group Description

Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.

The green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate.

Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.

The green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate.

Period Title: First Intervention (3 h Postprandially)
Started 8 7
Completed 8 7
Not Completed 0 0
Period Title: Wash-out Period (7 Days)
Started 8 7
Completed 8 7
Not Completed 0 0
Period Title: Second Intervention (3 h Postprandially)
Started 8 7
Completed 8 7
Not Completed 0 0
Arm/Group Title Baseline Participant Characteristics
Hide Arm/Group Description All participants completed both arms of the cross-over study
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
25.3  (3.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
0
   0.0%
Male
15
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 15 participants
22.4  (1.8)
Fasting Glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 15 participants
88.9  (5.2)
Total Cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 15 participants
160.5  (21.44)
1.Primary Outcome
Title Area Under the Curve of Blood Glucose
Hide Description 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.
Time Frame Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Green Tea Control
Hide Arm/Group Description:

Participants will be provided a confection containing green tea concentrate

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

Participants will be provided a confection devoid of green tea concentrate

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

Overall Number of Participants Analyzed 15 15
Mean (Standard Error)
Unit of Measure: mmol/L * min
998  (29) 981  (28)
2.Primary Outcome
Title Area Under the Curve of Brachial Artery Flow Mediated Dilatiion
Hide Description Brachial artery flow-mediated dilation will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes following the ingestion of a confection.
Time Frame Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Green Tea Control
Hide Arm/Group Description:

Participants will be provided a confection containing green tea concentrate

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

Participants will be provided a confection devoid of green tea concentrate

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

Overall Number of Participants Analyzed 15 15
Mean (Standard Error)
Unit of Measure: %FMD * min
614  (65) 653  (66)
3.Primary Outcome
Title Brachial Artery Flow-mediated Dilation
Hide Description [Not Specified]
Time Frame 0 min (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Green Tea
Hide Arm/Group Description:

Participants will be provided a confection devoid of green tea concentrate

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

Participants will be provided a confection containing green tea concentrate

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

Overall Number of Participants Analyzed 15 15
Mean (Standard Error)
Unit of Measure: % dilation
3.71  (0.42) 3.54  (0.42)
4.Primary Outcome
Title Brachial Artery Flow-mediated Dilation
Hide Description [Not Specified]
Time Frame 60 min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Green Tea
Hide Arm/Group Description:

Participants will be provided a confection devoid of green tea concentrate

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

Participants will be provided a confection containing green tea concentrate

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

Overall Number of Participants Analyzed 15 15
Mean (Standard Error)
Unit of Measure: % dilation
3.23  (0.44) 3.04  (0.35)
5.Secondary Outcome
Title Malondialdehyde (0 Min)
Hide Description [Not Specified]
Time Frame Baseline (0 min)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Green Tea Control
Hide Arm/Group Description:

Participants will be provided a confection containing green tea concentrate

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

Participants will be provided a confection devoid of green tea concentrate

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

Overall Number of Participants Analyzed 15 15
Mean (Standard Error)
Unit of Measure: uM
1.18  (0.15) 1.18  (0.16)
6.Secondary Outcome
Title Malondialdehyde
Hide Description [Not Specified]
Time Frame 60 min postprandially
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Green Tea Control
Hide Arm/Group Description:

Participants will be provided a confection containing green tea concentrate

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

Participants will be provided a confection devoid of green tea concentrate

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

Overall Number of Participants Analyzed 15 15
Mean (Standard Error)
Unit of Measure: uM
1.44  (0.15) 1.47  (0.14)
7.Secondary Outcome
Title Ratio of Asymmetric Dimethylarginine Relative to Arginine
Hide Description [Not Specified]
Time Frame 0 min (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Green Tea
Hide Arm/Group Description:

Participants will be provided a confection devoid of green tea concentrate

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

Participants will be provided a confection containing green tea concentrate

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

Overall Number of Participants Analyzed 15 15
Mean (Standard Error)
Unit of Measure: nmol/umol
5.75  (0.26) 6.24  (0.42)
8.Secondary Outcome
Title Ratio of Asymmetric Dimethylarginine Relative to Arginine
Hide Description [Not Specified]
Time Frame 60 min (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Green Tea
Hide Arm/Group Description:

Participants will be provided a confection devoid of green tea concentrate

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

Participants will be provided a confection containing green tea concentrate

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

Overall Number of Participants Analyzed 15 15
Mean (Standard Error)
Unit of Measure: nmol/umol
6.96  (0.51) 7.18  (0.53)
Time Frame Participants were monitored for any adverse events in response to ingesting starch-based confections containing no green tea or with green tea through study completion (9 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Green Tea, Then Control Control, Then Green Tea
Hide Arm/Group Description

Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.

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

Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.

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

All-Cause Mortality
Green Tea, Then Control Control, Then Green Tea
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Green Tea, Then Control Control, Then Green Tea
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Green Tea, Then Control Control, Then Green Tea
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%) 
This study was limited to normoglycemic adults who were healthy. Future studies may consider populations having glucose intolerance to examine the extent to which green tea attenuates starch-induced hyperglycemia.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Richard Bruno, PhD, RD
Organization: The Ohio State University
Phone: 6142925522
EMail: bruno.27@osu.edu
Layout table for additonal information
Responsible Party: Richard Bruno, Ohio State University
ClinicalTrials.gov Identifier: NCT01857258    
Other Study ID Numbers: 2013H0116
First Submitted: May 16, 2013
First Posted: May 20, 2013
Results First Submitted: September 30, 2016
Results First Posted: February 16, 2017
Last Update Posted: February 16, 2017