Cardiovascular DiseaseNCT03453073
Chocolate and CVD Risk in Postmenopausal Women
An observational study of Cardiovascular Disease and Heart Disease, run by Brooklyn College of the City University of New York.
Trial summary
The investigators will conduct an epidemiological analysis of data from the Women's Health Initiative to investigate the prospective association between chocolate intake and the risk of heart disease and stroke. Read more about this study
- Who is it for?
- Ages 55 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Heart Disease, Stroke
- What is being tested?
- chocolate consumption level and physician diagnosis of first occurrence of serious chronic disease
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 83,310 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2014to 1 Jul 2018
- Phase
- Observational
- 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 55 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: community residents
Who may be able to join
- Postmenopausal women
- age between 50 and 79 years
- enrolled in the Women's Health Initiative (WHI) Observational Study, or in the control arm of one or more overlapping WHI clinical trials.
Who cannot join
- implausible energy intakes, defined as <600 kcal/d or >5,000 kcal/d;
- implausible body mass indices (BMI) (<15 or >50 kg/m2)
- implausible height<122 cm (4 ft.)
- self-reported preexisting serious chronic disease at baseline, including diabetes, angina, myocardial infarction (MI), stroke, heart failure, coronary artery bypass graft, percutaneous coronary intervention or cancer.
- missing data on preexisting major chronic disease or any exposure, outcome or confounder variables.
About this study
Official title: Chocolate Intake and Heart Disease and Stroke in the Women's Health Initiative: a Prospective Analysis
The investigators will conduct an epidemiological analysis of data from the Women's Health Initiative to investigate the prospective association between chocolate intake and the risk of heart disease and stroke.
Read the detailed description
BACKGROUND: Three recent meta-analyses found significant prospective inverse associations between chocolate intake and cardiovascular disease risk. Evidence from these meta-analyses suggests that such inverse associations may only apply to elderly individuals or those with preexisting major chronic disease.
OBJECTIVE: The investigators will assess the association between habitual chocolate intake and subsequent incident coronary heart disease (CHD) and stroke, and the potential effect of modification by age.
DESIGN: The investigators will conduct multivariable Cox regression analyses using data from 83,310 postmenopausal women free of baseline preexisting major chronic disease in the prospective Women's Health Initiative cohort. Chocolate intake was assessed using a food frequency questionnaire. Physician adjudicated events or deaths were ascertained up to September 30, 2013.
- Conditions
- Cardiovascular Disease, Heart Disease, Stroke
- Being tested
- chocolate consumption level, physician diagnosis of first occurrence of serious chronic disease
- Keywords
- Coronary heart disease, stroke, chocolate consumption, postmenopausal women, nutrition, dietary intake, epidemiology
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Stroke, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chocolate consumption levelBehavioural
level of consumption of 1 oz. of chocolate, as assessed at baseline
physician diagnosis of first occurrence of serious chronic diseaseOther
| Study group | Role | What they receive |
|---|---|---|
| chocolate consumption level referent | women who ate 1 oz. (28.35 g) of chocolate <1 time/month Receives: Behavioral: chocolate consumption level | |
| chocolate consumption level 2 | women who ate 1 oz. (28.35 g) of chocolate between 1 and <1.5 times/month Receives: Behavioral: chocolate consumption level | |
| chocolate consumption level 3 | women who ate 1 oz. (28.35 g) of chocolate between 1.5 and <3.5 times/month, Receives: Behavioral: chocolate consumption level | |
| chocolate consumption level 4 | women who ate 1 oz. (28.35 g) of chocolate between 3.5 times/month and <3 times/week Receives: Behavioral: chocolate consumption level | |
| chocolate consumption level 5 | women who ate 1 oz. (28.35 g) of chocolate >3 times/week Receives: Behavioral: chocolate consumption level | |
| No physician diagnosis | No incidence of serious chronic disease prior to visit 3 Receives: Other: physician diagnosis of first occurrence of serious chronic disease | |
| Physician diagnosis | Incidence of serious chronic disease prior to visit 3 Receives: Other: physician diagnosis of first occurrence of serious chronic disease | |
| Younger | Age<65 years at follow-up baseline Receives: Behavioral: chocolate consumption level | |
| Older | Age>=65 years at follow-up baseline Receives: Behavioral: chocolate consumption level |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of heart disease
physician adjudicated first occurrence of, or death due to, heart disease
Measured: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
incidence of stroke
physician adjudicated first occurrence of, or death due to, stroke
Measured: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
incidence of heart disease or stroke
physician adjudicated first occurrence of, or death due to, heart disease or stroke
Measured: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
change in chocolate intake
change in chocolate intake between visit 1 and 3
Measured: time between the baseline and visit 3, average 3 years
change in dietary energy intake
change in dietary energy intake between visit 1 and 3
Measured: time between the baseline and year 3, average 3 years
change in dietary fat intake
change in dietary fat intake between visit 1 and 3
Measured: time between the baseline and year 3, average 3 years
change in BMI
change in BMI between visit 1 and 3
Measured: time between the baseline and year 3, average 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start15 Dec 2014
- Primary completion30 Apr 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 83,310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooklyn College of the City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Department of Health and Human Services
- Responsible party
- Principal investigator, James Greenberg, Brooklyn College of the City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453073
- Sponsor's protocol ID
- 438347-3
- Status last verified
- Nov 2020
- First submitted
- 18 Feb 2018
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenberg JA, Manson JE, Neuhouser ML, Tinker L, Eaton C, Johnson KC, Shikany JM. Chocolate intake and heart disease and stroke in the Women's Health Initiative: a prospective analysis. Am J Clin Nutr. 2018 Jul 1;108(1):41-48. doi: 10.1093/ajcn/nqy073.
PubMed 29931040
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chocolate Intake and Heart Disease and Stroke in the Women's Health Initiative: a Prospective Analysis
- ClinicalTrials.gov ID
- NCT03453073
- Acronym / sponsor ID
- 438347-3
- Conditions
- Cardiovascular Disease, Heart Disease, Stroke
- Keywords
- Coronary heart disease, stroke, chocolate consumption, postmenopausal women, nutrition, dietary intake, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83,310 participants (actual)
- Lead sponsor
- Brooklyn College of the City University of New YorkUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Department of Health and Human Services
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 5 Mar 2018 (actual)
- 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 investigators will conduct an epidemiological analysis of data from the Women's Health Initiative to investigate the prospective association between chocolate intake and the risk of heart disease and stroke.
Detailed description
BACKGROUND: Three recent meta-analyses found significant prospective inverse associations between chocolate intake and cardiovascular disease risk. Evidence from these meta-analyses suggests that such inverse associations may only apply to elderly individuals or those with preexisting major chronic disease.
OBJECTIVE: The investigators will assess the association between habitual chocolate intake and subsequent incident coronary heart disease (CHD) and stroke, and the potential effect of modification by age.
DESIGN: The investigators will conduct multivariable Cox regression analyses using data from 83,310 postmenopausal women free of baseline preexisting major chronic disease in the prospective Women's Health Initiative cohort. Chocolate intake was assessed using a food frequency questionnaire. Physician adjudicated events or deaths were ascertained up to September 30, 2013.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| chocolate consumption level referent | – | Behavioral: chocolate consumption levelwomen who ate 1 oz. (28.35 g) of chocolate <1 time/month |
| chocolate consumption level 2 | – | Behavioral: chocolate consumption levelwomen who ate 1 oz. (28.35 g) of chocolate between 1 and <1.5 times/month |
| chocolate consumption level 3 | – | Behavioral: chocolate consumption levelwomen who ate 1 oz. (28.35 g) of chocolate between 1.5 and <3.5 times/month, |
| chocolate consumption level 4 | – | Behavioral: chocolate consumption levelwomen who ate 1 oz. (28.35 g) of chocolate between 3.5 times/month and <3 times/week |
| chocolate consumption level 5 | – | Behavioral: chocolate consumption levelwomen who ate 1 oz. (28.35 g) of chocolate >3 times/week |
| No physician diagnosis | – | Other: physician diagnosis of first occurrence of serious chronic diseaseNo incidence of serious chronic disease prior to visit 3 |
| Physician diagnosis | – | Other: physician diagnosis of first occurrence of serious chronic diseaseIncidence of serious chronic disease prior to visit 3 |
| Younger | – | Behavioral: chocolate consumption levelAge<65 years at follow-up baseline |
| Older | – | Behavioral: chocolate consumption levelAge>=65 years at follow-up baseline |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community residents
Key inclusion criteria (3 listed)
- Postmenopausal women
- age between 50 and 79 years
- enrolled in the Women's Health Initiative (WHI) Observational Study, or in the control arm of one or more overlapping WHI clinical trials.
Key exclusion criteria (5 listed)
- implausible energy intakes, defined as <600 kcal/d or >5,000 kcal/d;
- implausible body mass indices (BMI) (<15 or >50 kg/m2)
- implausible height<122 cm (4 ft.)
- self-reported preexisting serious chronic disease at baseline, including diabetes, angina, myocardial infarction (MI), stroke, heart failure, coronary artery bypass graft, percutaneous coronary intervention or cancer.
- missing data on preexisting major chronic disease or any exposure, outcome or confounder variables.
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 |
|---|---|---|
| chocolate consumption levellevel of consumption of 1 oz. of chocolate, as assessed at baseline | Behavioural | Older, Younger, chocolate consumption level 2, chocolate consumption level 3, chocolate consumption level 4, chocolate consumption level 5, chocolate consumption level referent |
| physician diagnosis of first occurrence of serious chronic disease | Other | No physician diagnosis, Physician diagnosis |
Primary outcome
incidence of heart disease
Time frame: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
physician adjudicated first occurrence of, or death due to, heart disease
incidence of stroke
Time frame: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
physician adjudicated first occurrence of, or death due to, stroke
incidence of heart disease or stroke
Time frame: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
physician adjudicated first occurrence of, or death due to, heart disease or stroke
change in chocolate intake
Time frame: time between the baseline and visit 3, average 3 years
change in chocolate intake between visit 1 and 3
change in dietary energy intake
Time frame: time between the baseline and year 3, average 3 years
change in dietary energy intake between visit 1 and 3
change in dietary fat intake
Time frame: time between the baseline and year 3, average 3 years
change in dietary fat intake between visit 1 and 3
change in BMI
Time frame: time between the baseline and year 3, average 3 years
change in BMI between visit 1 and 3
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 6 Nov 2020.
- Results publication: PubMed 29931040Greenberg JA, Manson JE, Neuhouser ML, Tinker L, Eaton C, Johnson KC, Shikany JM. Chocolate intake and heart disease and stroke in the Women's Health Initiative: a prospective analysis. Am J Clin Nutr. 2018 Jul 1;108(1):41-48. doi: 10.1093/ajcn/nqy073.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Heart Disease, run by Brooklyn College of the City University of New York.
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 3 inclusion and 5 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 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
incidence of heart disease (time frame: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453073, which also lists 1 linked publication.
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 6 Nov 2020.