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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Green tea; Dietary supplement: 70% dark chocolate

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Center for Thrombosis Research, Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GT; 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.	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
Active Comparator: DC; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: LifeBridge Health
• Investigators: 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 record dates

Study Major Dates

• Study Start: September 1, 2006
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: November 15, 2007
• First Submitted That Met QC Criteria: November 15, 2007
• First Posted (Estimate): November 16, 2007

Study Record Updates

• Last Update Posted (Estimate): November 20, 2007
• Last Update Submitted That Met QC Criteria: November 16, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: platelet reactivity; HDL; hsCRP; LDL; Flavonoid
• Other Study ID Numbers: 1242