Flavonoid Effect on Activation and Stimulation of Thrombocytes, hsCRP and Lipid Profile (FEAST-CAL)

LifeBridge Health

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: 70% dark chocolate; Dietary Supplement: Green tea

Study type: Interventional

Funder types: Other

Identifiers

NCT00559663

1242

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

GT

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Green tea

DC

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: 70% dark chocolate