N/A
N=15
Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
Hyperglycemia · Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01857258 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Area Under the Curve of Blood Glucose — 998; 981 mmol/L * min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Green Tea Concentrate (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Ohio State University
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve of Blood Glucose |
998; 981 | — |
| PRIMARY Area Under the Curve of Brachial Artery Flow Mediated Dilatiion |
614; 653 | — |
| PRIMARY Brachial Artery Flow-mediated Dilation |
3.23; 3.04 | — |
| PRIMARY Brachial Artery Flow-mediated Dilation |
3.23; 3.04 | — |
| SECONDARY Malondialdehyde (0 Min) |
1.18; 1.18 | — |
| SECONDARY Malondialdehyde |
1.44; 1.47 | — |
| SECONDARY Ratio of Asymmetric Dimethylarginine Relative to Arginine |
6.96; 7.18 | — |
| SECONDARY Ratio of Asymmetric Dimethylarginine Relative to Arginine |
6.96; 7.18 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Plasma glucose 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
Data sourced from ClinicalTrials.gov (NCT01857258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.