Flavonoid Effect on Activation and Stimulation of Thrombocytes, hsCRP and Lipid Profile - Full Text View

Purpose

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

U.S. FDA Resources

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

Further study details as provided by LifeBridge Health:

Primary Outcome Measures:

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. [ Time Frame: one week of dark chocolate versus one week of green tea ingestion ]

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.	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.	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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559663

Locations


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

Sponsors and Collaborators

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

More Information

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

Keywords provided by LifeBridge Health:

Flavonoid

hsCRP

HDL

LDL

platelet reactivity

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	LifeBridge Health
Information provided by:	LifeBridge Health
ClinicalTrials.gov Identifier:	NCT00559663