Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 16, 2013
CompletedFirst Posted
Study publicly available on registry
May 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
February 16, 2017
CompletedFebruary 16, 2017
February 1, 2017
1.8 years
May 16, 2013
September 30, 2016
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
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)
Study Arms (2)
Green Tea
EXPERIMENTALParticipants will be provided a confection containing green tea concentrate
Control
ACTIVE COMPARATORParticipants will be provided a confection devoid of green tea concentrate
Interventions
Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- allergies or aversions to green tea and/or corn starch,
- excessive alcohol consumption (\>3 drinks/d),
- \>5 h/wk of aerobic activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University
Columbus, Ohio, 43210, United States
Related 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 normoglycemic adults. Food Funct. 2016 Sep 14;7(9):3843-53. doi: 10.1039/c6fo00639f. Epub 2016 Aug 5.
PMID: 27494176RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Richard Bruno, PhD, RD
- Organization
- The Ohio State University
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Bruno, PhD, RD
Ohio State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 16, 2013
First Posted
May 20, 2013
Study Start
May 1, 2013
Primary Completion
February 1, 2015
Study Completion
April 1, 2016
Last Updated
February 16, 2017
Results First Posted
February 16, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share