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| ID | Type | Description | Link |
|---|---|---|---|
| 1242 |
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The purpose of this study is to compare the effect of dark chocolate with green tea in healthy subjects on clot formation (platelet activity) cholesterol profile and markers of inflammation in two groups.
The first group will be on a regimen of dark chocolate, and the second group will be on a regimen of green tea. Clinical outcomes will be determined after seven days of each treatment and both groups will undergo both treatments subsequently and serve as their own control.
The hypothesis is that both green tea and dark chocolate will reduce platelet activity and reduce LDL, hsCRP and increase HDL.
Flavonoids are polyphenolic compounds ubiquitous in fruits and vegetables. They appear in especially high concentrations in the form of flavanols in green tea as well as in cocoa, and are known to have beneficial antioxidant effects in vitro. Flavonoids have been proposed as a key protective dietary component, reducing the risk of coronary heart disease, including the reduction of elevated blood pressure in persons with hypertension and capable of decreasing LDL.
The aim of this prospective single cross-over study is to assess the effect of green tea and dark chocolate consumption on inhibiting platelet activation, Lipid levels, and hsCRP in healthy volunteers.
This research will be done at Sinai Hospital of Baltimore and will include 35 subjects who will be randomized equally between the two groups.
All blood work will be processed at the Sinai Center for Thrombosis Research. Clinical outcomes will be recorded using a standard case report form.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT | Active Comparator | The green tea group is given initially green tea treatment and then after a washout period of four weeks switched to the dark chocolate treatment. |
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| DC | Active Comparator | The dark chocolate group is given initially dark chocolate treatment and then after a washout period of four weeks switched to the green tea treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green tea | Dietary Supplement | The green tea group consumed first daily one liter of green tea infusate made of 4 bags left in boiling water during 3 minutes. After a four week washout-time they were switched over to the dark chocolate treatment, which included consumption of 3.5 ounces 70% dark chocolate. Blood was drawn before and after each intervention, to check platelet activity with flow cytometry, HDL, LDL and hsCRP Levels |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome was the absolute change in platelet activity measured by Flow Cytometry, HDL, LDL and hsCRP after dark chocolate, respective green tea treatment. | one week of dark chocolate versus one week of green tea ingestion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul A Gurbel, MD | Sinai Hospital of Baltimore | Principal Investigator |
| Miruais S Hamed, MD | Department of Medicine, Sinai Hospital, Baltimore | Study Director |
| Kevin Bliden, BS | Sinai Center for Thrombosis Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Thrombosis Research, Sinai Hospital | Baltimore | Maryland | 21215 | United States |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| 70% dark chocolate | Dietary Supplement | The dark chocolate group consumed 3.5 ounces 70% dark chocolate per day during a one week period. After a four week washout-time they were given the green tea treatment, which included ingestion of one liter green tea infusate (containing 4 green tea bags). Blood was drawn before and after each intervention, to check platelet activity with flow cytometry, HDL, LDL and hsCRP Levels. |
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| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |