Chocolate and CVD Risk in Postmenopausal Women

Brooklyn College of the City University of New York83,310 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

83,310

Conditions

Cardiovascular Disease Heart Disease Stroke

Interventions

chocolate consumption levelBEHAVIORAL

level of consumption of 1 oz. of chocolate, as assessed at baseline

physician diagnosis of first occurrence of serious chronic diseaseOTHER

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

incidence of heart disease

physician adjudicated first occurrence of, or death due to, heart disease

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: time between the baseline and year 3, average 3 years

change in BMI

change in BMI between visit 1 and 3

Time frame: time between the baseline and year 3, average 3 years

Data from ClinicalTrials.gov

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