Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
Primary Purpose
Hyperglycemia, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Green Tea Concentrate
Sponsored by
About this trial
This is an interventional prevention trial for Hyperglycemia focused on measuring green tea, catechins, vascular endothelial function, postprandial hyperglycemia, oxidative stress
Eligibility Criteria
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
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Green Tea
Control
Arm Description
Participants will be provided a confection containing green tea concentrate
Participants will be provided a confection devoid of green tea concentrate
Outcomes
Primary Outcome Measures
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 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.
Brachial Artery Flow-mediated Dilation
Brachial Artery Flow-mediated Dilation
Secondary Outcome Measures
Malondialdehyde (0 Min)
Malondialdehyde
Ratio of Asymmetric Dimethylarginine Relative to Arginine
Ratio of Asymmetric Dimethylarginine Relative to Arginine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01857258
Brief Title
Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
Official Title
Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Cardiovascular Disease
Keywords
green tea, catechins, vascular endothelial function, postprandial hyperglycemia, oxidative stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Green Tea
Arm Type
Experimental
Arm Description
Participants will be provided a confection containing green tea concentrate
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will be provided a confection devoid of green tea concentrate
Intervention Type
Dietary Supplement
Intervention Name(s)
Green Tea Concentrate
Intervention Description
Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose
Primary Outcome Measure Information:
Title
Area Under the Curve of Blood Glucose
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
Title
Area Under the Curve of Brachial Artery Flow Mediated Dilatiion
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
Title
Brachial Artery Flow-mediated Dilation
Time Frame
0 min (baseline)
Title
Brachial Artery Flow-mediated Dilation
Time Frame
60 min
Secondary Outcome Measure Information:
Title
Malondialdehyde (0 Min)
Time Frame
Baseline (0 min)
Title
Malondialdehyde
Time Frame
60 min postprandially
Title
Ratio of Asymmetric Dimethylarginine Relative to Arginine
Time Frame
0 min (baseline)
Title
Ratio of Asymmetric Dimethylarginine Relative to Arginine
Time Frame
60 min (baseline)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Bruno, PhD, RD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
27494176
Citation
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.
Results Reference
result
Learn more about this trial
Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
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