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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Green Tea | Experimental | Participants will be provided a confection containing green tea concentrate |
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| Control | Active Comparator | Participants will be provided a confection devoid of green tea concentrate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green Tea Concentrate | Dietary Supplement | Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Malondialdehyde (0 Min) | Baseline (0 min) | |
| Malondialdehyde | 60 min postprandially | |
| Ratio of Asymmetric Dimethylarginine Relative to Arginine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Bruno, PhD, RD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27494176 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (3 h Postprandially) |
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| Wash-out Period (7 Days) |
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| Second Intervention (3 h Postprandially) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Participant Characteristics | All participants completed both arms of the cross-over study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | mmol/L * min | Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose |
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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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Green Tea, 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. Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Bruno, PhD, RD | The Ohio State University | 6142925522 | bruno.27@osu.edu |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 0 min (baseline) |
| Ratio of Asymmetric Dimethylarginine Relative to Arginine | 60 min (baseline) |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Fasting Glucose | Mean | Standard Deviation | mg/dL |
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| Total Cholesterol | Mean | Standard Deviation | mg/dL |
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| Primary | 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. | Posted | Mean | Standard Error | %FMD * min | Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose |
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| Primary | Brachial Artery Flow-mediated Dilation | Posted | Mean | Standard Error | % dilation | 0 min (baseline) |
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| Primary | Brachial Artery Flow-mediated Dilation | Posted | Mean | Standard Error | % dilation | 60 min |
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| Secondary | Malondialdehyde (0 Min) | Posted | Mean | Standard Error | uM | Baseline (0 min) |
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| Secondary | Malondialdehyde | Posted | Mean | Standard Error | uM | 60 min postprandially |
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| Secondary | Ratio of Asymmetric Dimethylarginine Relative to Arginine | Posted | Mean | Standard Error | nmol/umol | 0 min (baseline) |
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| Secondary | Ratio of Asymmetric Dimethylarginine Relative to Arginine | Posted | Mean | Standard Error | nmol/umol | 60 min (baseline) |
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| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Control, 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. Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose | 0 | 7 | 0 | 7 |
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