Chocolate and CVD Risk in Postmenopausal Women

Completed

• Conditions: Stroke; Cardiovascular Disease; Heart Disease

• Registration Number: NCT03453073
• Lead Sponsor: Brooklyn College of the City University of New York

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.

Study Timeline

• Study Start: 2014-12-15
• Study First Submitted: 2018-02-18
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-03-05
• Primary Completion: 2018-04-30
• Study Completion: 2018-07-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83310

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of heart disease	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	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	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 between the baseline and visit 3, average 3 years	change in chocolate intake between visit 1 and 3
change in dietary energy intake	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 between the baseline and year 3, average 3 years	change in dietary fat intake between visit 1 and 3
change in BMI	time between the baseline and year 3, average 3 years	change in BMI between visit 1 and 3