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Sponsored by: |
LifeBridge Health |
Information provided by: | LifeBridge Health |
ClinicalTrials.gov Identifier: | NCT00559663 |
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.
Condition | Intervention |
Healthy |
Dietary Supplement: Green tea Dietary Supplement: 70% dark chocolate |
MedlinePlus related topics: | Dietary Supplements |
ChemIDplus related topics: | Lipids |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment |
Official Title: | Flavonoid Effect on Activation and Stimulation of Thrombocytes, hsCRP and Lipid Profile |
Enrollment: | 35 |
Study Start Date: | September 2006 |
Study Completion Date: | April 2007 |
Arms | Assigned Interventions |
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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Dietary Supplement: Green tea
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 |
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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Dietary Supplement: 70% dark chocolate
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. |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |||||
Center for Thrombosis Research, Sinai Hospital | |||||
Baltimore, Maryland, United States, 21215 |
LifeBridge Health |
Principal Investigator: | Paul A Gurbel, MD | Sinai Hospital of Baltimore |
Study Director: | Miruais S Hamed, MD | Department of Medicine, Sinai Hospital, Baltimore |
Study Chair: | Kevin Bliden, BS | Sinai Center for Thrombosis Research |
Study ID Numbers: | 1242, 1242 |
First Received: | November 15, 2007 |
Last Updated: | November 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00559663 |
Health Authority: | United States: Institutional Review Board |
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