Clinical trial NCT03453073: Chocolate and CVD Risk in Postmenopausal Women
Official title: Chocolate Intake and Heart Disease and Stroke in the Women's Health Initiative: a Prospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Heart Disease
Stroke
Keywords: Coronary heart disease
stroke
chocolate consumption
postmenopausal women
nutrition
dietary intake
epidemiology
Lead sponsor: Brooklyn College of the City University of New York
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Department of Health and Human Services
First posted: 2018-03-05
Enrollment: 83310
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community residents

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Postmenopausal women
2. age between 50 and 79 years
3. enrolled in the Women's Health Initiative (WHI) Observational Study, or in the control arm of one or more overlapping WHI clinical trials.

Exclusion Criteria:

1. implausible energy intakes, defined as \<600 kcal/d or \>5,000 kcal/d;
2. implausible body mass indices (BMI) (\<15 or \>50 kg/m2)
3. implausible height\<122 cm (4 ft.)
4. 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.
5. missing data on preexisting major chronic disease or any exposure, outcome or confounder variables.

Primary outcomes:
measure: incidence of heart disease
timeFrame: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
measure: incidence of stroke
timeFrame: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
measure: incidence of heart disease or stroke
timeFrame: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
measure: change in chocolate intake
timeFrame: time between the baseline and visit 3, average 3 years
measure: change in dietary energy intake
timeFrame: time between the baseline and year 3, average 3 years
measure: change in dietary fat intake
timeFrame: time between the baseline and year 3, average 3 years
measure: change in BMI
timeFrame: time between the baseline and year 3, average 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.