HealthyFEAST-CALNCT00559663
Flavonoid Effect on Activation and Stimulation of Thrombocytes, hsCRP and Lipid Profile
A study testing Green tea and 70% dark chocolate in people with Healthy, run by LifeBridge Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Green tea and 70% dark chocolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smokers between the ages of 18-60
- BMI of 19 to 30
Who cannot join
- 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
Show all 9Show fewer
- known cardiovascular disease (prior myocardial infarction)
- drug abuse
- Diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Thrombosis Research, Sinai Hospital
Baltimore, Maryland, 21215
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Green tea, 70% dark chocolate
- Keywords
- Flavonoid, hsCRP, HDL, LDL, platelet reactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green teaDietary 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
70% dark chocolateDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: 70% dark chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week of dark chocolate versus one week of green tea ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startSep 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Investigators
- Paul A Gurbel, MD, Principal investigator, Sinai Hospital of BaltimoreMiruais S Hamed, MD, Study director, Department of Medicine, Sinai Hospital, BaltimoreKevin Bliden, BS, Study chair, Sinai Center for Thrombosis Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559663
- Sponsor's protocol ID
- 1242
- Other IDs
- 1242
- Acronym
- FEAST-CAL
- Status last verified
- Nov 2007
- First submitted
- 15 Nov 2007
- Last updated
- 20 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flavonoid Effect on Activation and Stimulation of Thrombocytes, hsCRP and Lipid Profile
- ClinicalTrials.gov ID
- NCT00559663
- Acronym / sponsor ID
- FEAST-CAL / 1242
- Conditions
- Healthy
- Keywords
- Flavonoid, hsCRP, HDL, LDL, platelet reactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GT | Active comparator | Dietary Supplement: Green teaThe green tea group is given initially green tea treatment and then after a washout period of four weeks switched to the dark chocolate treatment. |
| DC | Active comparator | Dietary Supplement: 70% dark chocolateThe dark chocolate group is given initially dark chocolate treatment and then after a washout period of four weeks switched to the green tea treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- non-smokers between the ages of 18-60
- BMI of 19 to 30
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green teaThe 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 | Dietary supplement | GT |
| 70% dark chocolateThe 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. | Dietary supplement | DC |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2007.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Gurbel, MD principal investigator
Sinai Hospital of Baltimore
Miruais S Hamed, MD study director
Department of Medicine, Sinai Hospital, Baltimore
Kevin Bliden, BS study chair
Sinai Center for Thrombosis Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green tea and 70% dark chocolate in people with Healthy, run by LifeBridge Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: one week of dark chocolate versus one week of green tea ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2007.