Healthy
Conditions
Keywords
Flavonoid, hsCRP, HDL, LDL, platelet reactivity
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTGreen 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
DIETARY_SUPPLEMENT70% 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.
Sponsors
LifeBridge Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* non-smokers between the ages of 18-60 * BMI of 19 to 30
Exclusion criteria
* prior usage of Vitamin C \> 1000 mg, Vitamin E \> 400IU, Beta Carotene \> 1000IU, Vitamin A \> 5000IU, Selenium \> 200mcg, Folic Acid \> 1mg, Aspirin or NSAIDs four weeks prior to study initiation * regular ingestion of Flavonoid rich food (EG green tea, dark chocolate, grapes, red wine and others) prior and during the study except what was provided by the study protocol * Alcohol or Caffeine consumption 24 prior to blood draws * Nursing or pregnant women * blood donation up to eight weeks prior to study initiation * subjects with coagulation disorders * known cardiovascular disease (prior myocardial infarction) * drug abuse * Diabetes
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed