Flavonoid Effect on Activation and Stimulation of Thrombocytes, hsCRP and Lipid Profile

NCT00559663 | Completed DMC

• 1 other identifier: 1242
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Flavonoid; hsCRP; HDL; LDL; platelet reactivity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Green tea DIETARY_SUPPLEMENT

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

GT

70% dark chocolate DIETARY_SUPPLEMENT

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.

DC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• non-smokers between the ages of 18-60
• BMI of 19 to 30

You may not qualify if:

• 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

Sponsors & Collaborators

• LifeBridge Health: lead

Study Sites (1)

Center for Thrombosis Research, Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Paul A Gurbel, MD

  Sinai Hospital of Baltimore

  PRINCIPAL INVESTIGATOR

• Miruais S Hamed, MD

  Department of Medicine, Sinai Hospital, Baltimore

  STUDY DIRECTOR

• Kevin Bliden, BS

  Sinai Center for Thrombosis Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: September 1, 2006
• Study Completion: April 1, 2007
• Last Updated: November 20, 2007

Record last verified: 2007-11

Locations

US (1)