Trial Outcomes & Findings for Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction (NCT NCT01857258)

NCT ID: NCT01857258

Last Updated: 2017-02-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose
• Results posted on: 2017-02-16

Participant Flow

Participant milestones

Measure	Green Tea First, Then Control 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.	Control First, Then Green Tea 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.
First Intervention (3 h Postprandially) STARTED	8	7
First Intervention (3 h Postprandially) COMPLETED	8	7
First Intervention (3 h Postprandially) NOT COMPLETED	0	0
Wash-out Period (7 Days) STARTED	8	7
Wash-out Period (7 Days) COMPLETED	8	7
Wash-out Period (7 Days) NOT COMPLETED	0	0
Second Intervention (3 h Postprandially) STARTED	8	7
Second Intervention (3 h Postprandially) COMPLETED	8	7
Second Intervention (3 h Postprandially) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Baseline Participant Characteristics n=15 Participants All participants completed both arms of the cross-over study
Age, Continuous	25.3 years STANDARD_DEVIATION 3.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Body Mass Index	22.4 kg/m^2 STANDARD_DEVIATION 1.8 • n=5 Participants
Fasting Glucose	88.9 mg/dL STANDARD_DEVIATION 5.2 • n=5 Participants
Total Cholesterol	160.5 mg/dL STANDARD_DEVIATION 21.44 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Green Tea n=15 Participants 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	Control n=15 Participants 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
Area Under the Curve of Blood Glucose	998 mmol/L * min Standard Error 29	981 mmol/L * min Standard Error 28

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Green Tea n=15 Participants 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	Control n=15 Participants 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
Area Under the Curve of Brachial Artery Flow Mediated Dilatiion	614 %FMD * min Standard Error 65	653 %FMD * min Standard Error 66

PRIMARY outcome

Timeframe: 0 min (baseline)

Outcome measures

Measure	Green Tea n=15 Participants 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	Control n=15 Participants 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
Brachial Artery Flow-mediated Dilation	3.71 % dilation Standard Error 0.42	3.54 % dilation Standard Error 0.42

PRIMARY outcome

Timeframe: 60 min

Outcome measures

Measure	Green Tea n=15 Participants 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	Control n=15 Participants 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
Brachial Artery Flow-mediated Dilation	3.23 % dilation Standard Error 0.44	3.04 % dilation Standard Error 0.35

SECONDARY outcome

Timeframe: Baseline (0 min)

Outcome measures

Measure	Green Tea n=15 Participants 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	Control n=15 Participants 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
Malondialdehyde (0 Min)	1.18 uM Standard Error 0.15	1.18 uM Standard Error 0.16

SECONDARY outcome

Timeframe: 60 min postprandially

Outcome measures

Measure	Green Tea n=15 Participants 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	Control n=15 Participants 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
Malondialdehyde	1.44 uM Standard Error 0.15	1.47 uM Standard Error 0.14

SECONDARY outcome

Timeframe: 0 min (baseline)

Outcome measures

Measure	Green Tea n=15 Participants 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	Control n=15 Participants 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
Ratio of Asymmetric Dimethylarginine Relative to Arginine	5.75 nmol/umol Standard Error 0.26	6.24 nmol/umol Standard Error 0.42

SECONDARY outcome

Timeframe: 60 min (baseline)

Outcome measures

Measure	Green Tea n=15 Participants 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	Control n=15 Participants 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
Ratio of Asymmetric Dimethylarginine Relative to Arginine	6.96 nmol/umol Standard Error 0.51	7.18 nmol/umol Standard Error 0.53

Adverse Events

Green Tea, Then Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control, Then Green Tea

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Bruno, PhD, RD

The Ohio State University

Phone: 6142925522

Email: bruno.27@osu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place