Flavonoid Effect on Activation and Stimulation of Thrombocytes, hsCRP and Lipid Profile
NCT ID: NCT00559663
Last Updated: 2007-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2006-09-30
2007-04-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
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
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.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* BMI of 19 to 30
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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LifeBridge Health
OTHER
Principal Investigators
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Paul A Gurbel, MD
Role: PRINCIPAL_INVESTIGATOR
Sinai Hospital of Baltimore
Miruais S Hamed, MD
Role: STUDY_DIRECTOR
Department of Medicine, Sinai Hospital, Baltimore
Kevin Bliden, BS
Role: STUDY_CHAIR
Sinai Center for Thrombosis Research
Locations
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Center for Thrombosis Research, Sinai Hospital
Baltimore, Maryland, United States
Countries
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Other Identifiers
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1242
Identifier Type: -
Identifier Source: secondary_id
1242
Identifier Type: -
Identifier Source: org_study_id