CardioprotectionPhase 1ChocolateNCT00538083
Cocoa and Endothelial Function in Adults With Elevated BMI
A Phase 1 study testing Chocolate in people with Cardioprotection, run by Griffin Hospital at 1 site in United States.
Trial summary
Cardiovascular disease is the leading cause of death in the United States. Studies have shown that obesity is an important risk factor for development of cardiovascular disease. Endothelial dysfunction, a pathologic feature of obesity, predicts the occurrence of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardioprotection
- What is being tested?
- Chocolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to May 2006
- Phase
- Phase 1
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages between 30 -75
- BMI between 25-35 kg/m2
- waist circumference above 88 cms. in women and 102 cms. in men
- non-smoker
- no strenuous exercise at least 8 hours prior to scanning
- to facilitate recruitment individuals with diagnosed hypertension or hyperlipidemia will be included provided that they have been stable on their medications for three months, and can refrain from taking their medication 12 hours prior to BARS testing.
Who cannot join
- Failure to meet inclusion criteria
- anticipated inability to complete study protocol for any reason
- current eating disorder
- diagnosed coronary artery disease
- diabetes
- sleep apnea
Show all 12Show fewer
- current or impending pregnancy
- insulin or glucose sensitizing medication use, vasoactive medication or nutriceutical use (glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators)
- regular use of high dose vitamin E or C and unable to discontinue for duration of the study
- regular use of fiber supplements and unable to discontinue for duration of the study
- restricted diets by choice (i.e. vegan, Atkins diet etc)
- allergy to cocoa or chocolate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dark Chocolate and Cocoa Ingestion and Endothelial Function: A Randomized, Placebo Controlled, Cross-over Trial
Cardiovascular disease is the leading cause of death in the United States. Studies have shown that obesity is an important risk factor for development of cardiovascular disease. Endothelial dysfunction, a pathologic feature of obesity, predicts the occurrence of cardiovascular disease. Recent research findings indicate that consumption of cocoa exerts cardioprotective effects, which include increasing HDL levels, reduction in systolic BP, inhibition of platelet aggregation/activity and activation of endothelial nitric oxide synthase.
Proposed is a randomized controlled trial consisting of 4 phases designed to examine the dose-response, and the acute and sustained effects of cocoa consumption on endothelial function as a marker of cardiovascular disease risk in 45 otherwise healthy adults with a BMI 25-35kg/m2.
Read the detailed description
Endothelial function has been used extensively to evaluate the acute and chronic effects of foods and nutrients on cardiac risk and can provide a direct measurement of the effect of cocoa powder consumption on vascular physiology in healthy adults with BMI between 25-35 kg/m2.
To our knowledge, our study is the first to examine the dose response effects of sugar free, liquid, cocoa and solid, dark chocolate with sugar consumption on FMD, concentrating on individuals with elevated BMI. Given the current epidemic of obesity in the United States; its role as a risk factor in the development of cardiovascular disease; and the fact that cardiovascular disease is the leading cause of mortality in this country, examination of the cardio-protective effects of cocoa or dark chocolate in an at risk population is of considerable potential interest. Demonstrating that ingestion of cocoa may reverse damage caused to the endothelium may lead to new dietary recommendations that may help curb the prevalence of heart disease in the U.S.
- Conditions
- Cardioprotection
- Being tested
- Chocolate
- Keywords
- Cocoa, Overweight adults, Endothelial function, Blood pressure, Cardiovascular disease risk, Dark chocolate, Sugar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChocolateOther
74 grams of single dose solid dark chocolate versus placebo
ChocolateOther
22 grams of single dose sugared cocoa, sugar-free cocoa, and placebo
ChocolateOther
22 grams of sugared cocoa, sugar-free cocoa, \& placebo given for six weeks
| Study group | Role | What they receive |
|---|---|---|
| 1, 2 | Experimental | acute phase, solid dark chocolate, placebo Receives: Other: Chocolate |
| 3, 4, 5 | Experimental | acute phase, sugared cocoa, sugar-free cocoa, placebo Receives: Other: Chocolate |
| 6, 7, 8 | Experimental | sustained phase, sugared cocoa, sugar-free cocoa, placebo Receives: Other: Chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function(acute & sustained phase)
Measured: Single dose(acute phase), 6 weeks (sustained phase)
Secondary outcomes (1)
Blood Pressure(acute and sustained phase), lipid profile(sustained), LDL oxidation(sustained), lipid hydroperoxide(sustained), CRP(sustained), blood glucose(sustained), body weight(sustained), waist circumference(sustained), endothelin(sustained)
Measured: Single dose(acute phase), 6 weeks(sustained phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startAug 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardioprotectionStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Griffin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, The Hershey Company
- Investigators
- David L Katz, MD, Principal investigator, Yale-Griffin Prevention Research CenterZubaida Faridi, MPH, Study director, Yale-Griffin Prevention Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538083
- Sponsor's protocol ID
- 2005-12
- Acronym
- Chocolate
- Status last verified
- Mar 2020
- First submitted
- 28 Sep 2007
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dark Chocolate and Cocoa Ingestion and Endothelial Function: A Randomized, Placebo Controlled, Cross-over Trial
- ClinicalTrials.gov ID
- NCT00538083
- Acronym / sponsor ID
- Chocolate / 2005-12
- Conditions
- Cardioprotection
- Keywords
- Cocoa, Overweight adults, Endothelial function, Blood pressure, Cardiovascular disease risk, Dark chocolate, Sugar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Griffin HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, The Hershey Company
- Study start
- Aug 2005
- Study completion
- May 2006 (actual)
- First posted
- 2 Oct 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.
Cardiovascular disease is the leading cause of death in the United States. Studies have shown that obesity is an important risk factor for development of cardiovascular disease. Endothelial dysfunction, a pathologic feature of obesity, predicts the occurrence of cardiovascular disease. Recent research findings indicate that consumption of cocoa exerts cardioprotective effects, which include increasing HDL levels, reduction in systolic BP, inhibition of platelet aggregation/activity and activation of endothelial nitric oxide synthase.
Proposed is a randomized controlled trial consisting of 4 phases designed to examine the dose-response, and the acute and sustained effects of cocoa consumption on endothelial function as a marker of cardiovascular disease risk in 45 otherwise healthy adults with a BMI 25-35kg/m2.
Detailed description
Endothelial function has been used extensively to evaluate the acute and chronic effects of foods and nutrients on cardiac risk and can provide a direct measurement of the effect of cocoa powder consumption on vascular physiology in healthy adults with BMI between 25-35 kg/m2.
To our knowledge, our study is the first to examine the dose response effects of sugar free, liquid, cocoa and solid, dark chocolate with sugar consumption on FMD, concentrating on individuals with elevated BMI. Given the current epidemic of obesity in the United States; its role as a risk factor in the development of cardiovascular disease; and the fact that cardiovascular disease is the leading cause of mortality in this country, examination of the cardio-protective effects of cocoa or dark chocolate in an at risk population is of considerable potential interest. Demonstrating that ingestion of cocoa may reverse damage caused to the endothelium may lead to new dietary recommendations that may help curb the prevalence of heart disease in the U.S.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1, 2 | Experimental | Other: Chocolateacute phase, solid dark chocolate, placebo |
| 3, 4, 5 | Experimental | Other: Chocolateacute phase, sugared cocoa, sugar-free cocoa, placebo |
| 6, 7, 8 | Experimental | Other: Chocolatesustained phase, sugared cocoa, sugar-free cocoa, placebo |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages between 30 -75
- BMI between 25-35 kg/m2
- waist circumference above 88 cms. in women and 102 cms. in men
- non-smoker
- no strenuous exercise at least 8 hours prior to scanning
Key exclusion criteria (12 listed)
- Failure to meet inclusion criteria
- anticipated inability to complete study protocol for any reason
- current eating disorder
- diagnosed coronary artery disease
- diabetes
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 |
|---|---|---|
| Chocolate74 grams of single dose solid dark chocolate versus placebo | Other | 1, 2 |
| Chocolate22 grams of single dose sugared cocoa, sugar-free cocoa, and placebo | Other | 3, 4, 5 |
| Chocolate22 grams of sugared cocoa, sugar-free cocoa, \& placebo given for six weeks | Other | 6, 7, 8 |
Primary outcome
Endothelial Function(acute & sustained phase)
Time frame: Single dose(acute phase), 6 weeks (sustained phase)
1 secondary outcome
Blood Pressure(acute and sustained phase), lipid profile(sustained), LDL oxidation(sustained), lipid hydroperoxide(sustained), CRP(sustained), blood glucose(sustained), body weight(sustained), waist circumference(sustained), endothelin(sustained)
Time frame: Single dose(acute phase), 6 weeks(sustained phase)
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 26 Mar 2020.
Related trials for Cardioprotection
Not yet recruitingPhase 3
Cardioprotection Effect of Linagliptin
Cardiotoxicity
Active, not recruitingPhase 4
Finerenone Plus SGLT2 Inhibitors in Heart Failure
Heart Failure
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingPhase 3
Cardioprotective Effect of Empagliflozin in Breast Cancer Patients
Empgliflozin Cardioprotective Effect
Not yet recruitingObservational study
Nerve Block and Perioperative Myocardial Injury in Elderly Hip Fracture
Hip Fracture, Perioperative Myocardial Injury
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.
David L Katz, MD principal investigator
Yale-Griffin Prevention Research Center
Zubaida Faridi, MPH study director
Yale-Griffin Prevention Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chocolate in people with Cardioprotection, run by Griffin Hospital 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 6 inclusion and 12 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 26 Mar 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Endothelial Function(acute & sustained phase) (time frame: Single dose(acute phase), 6 weeks (sustained phase)). 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 26 Mar 2020.