NCT03453073

Chocolate and CVD Risk in Postmenopausal Women

Chocolate Intake and Heart Disease and Stroke in the Women's Health Initiative: a Prospective Analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 83,310 (actual)
• Sponsor: Brooklyn College of the City University of New York · Academic / Other
• Sex: Female
• Age: 55 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Disease
• Heart Disease
• Stroke

Interventions

Type	Name	Description
BEHAVIORAL	chocolate consumption level	level of consumption of 1 oz. of chocolate, as assessed at baseline
OTHER	physician diagnosis of first occurrence of serious chronic disease

Timeline

• Start date: 2014-12-15
• Primary completion: 2018-04-30
• Completion: 2018-07-01
• First posted: 2018-03-05
• Last updated: 2020-11-06