Clinical trial NCT00559663: Flavonoid Effect on Activation and Stimulation of Thrombocytes, hsCRP and Lipid Profile
Official title: Flavonoid Effect on Activation and Stimulation of Thrombocytes, hsCRP and Lipid Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Flavonoid
hsCRP
HDL
LDL
platelet reactivity
Lead sponsor: LifeBridge Health
Sponsor class: OTHER
First posted: 2007-11-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: one week of dark chocolate versus one week of green tea ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Center for Thrombosis Research, Sinai Hospital
state: Maryland
Study officials:
affiliation: Sinai Hospital of Baltimore
name: Paul A Gurbel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine, Sinai Hospital, Baltimore
name: Miruais S Hamed, MD
role: STUDY_DIRECTOR
affiliation: Sinai Center for Thrombosis Research
name: Kevin Bliden, BS
role: STUDY_CHAIR
References: