Chocolate and CVD Risk in Postmenopausal Women

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Cardiovascular Disease; Heart Disease
• Intervention / Treatment: Behavioral: chocolate consumption level; Other: physician diagnosis of first occurrence of serious chronic disease

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 Type: Observational
• Enrollment (Actual): 83310

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

community residents

Description

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 Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
chocolate consumption level referent; women who ate 1 oz. (28.35 g) of chocolate <1 time/month	Behavioral: chocolate consumption level; level of consumption of 1 oz. of chocolate, as assessed at baseline
chocolate consumption level 2; women who ate 1 oz. (28.35 g) of chocolate between 1 and <1.5 times/month	Behavioral: chocolate consumption level; level of consumption of 1 oz. of chocolate, as assessed at baseline
chocolate consumption level 3; women who ate 1 oz. (28.35 g) of chocolate between 1.5 and <3.5 times/month,	Behavioral: chocolate consumption level; level of consumption of 1 oz. of chocolate, as assessed at baseline
chocolate consumption level 4; women who ate 1 oz. (28.35 g) of chocolate between 3.5 times/month and <3 times/week	Behavioral: chocolate consumption level; level of consumption of 1 oz. of chocolate, as assessed at baseline
chocolate consumption level 5; women who ate 1 oz. (28.35 g) of chocolate >3 times/week	Behavioral: chocolate consumption level; level of consumption of 1 oz. of chocolate, as assessed at baseline
No physician diagnosis; No incidence of serious chronic disease prior to visit 3	Other: physician diagnosis of first occurrence of serious chronic disease
Physician diagnosis; Incidence of serious chronic disease prior to visit 3	Other: physician diagnosis of first occurrence of serious chronic disease
Younger; Age<65 years at follow-up baseline	Behavioral: chocolate consumption level; level of consumption of 1 oz. of chocolate, as assessed at baseline
Older; Age>=65 years at follow-up baseline	Behavioral: chocolate consumption level; level of consumption of 1 oz. of chocolate, as assessed at baseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of heart disease	physician adjudicated first occurrence of, or death due to, heart disease	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	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	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 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 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 between the baseline and year 3, average 3 years
change in BMI	change in BMI between visit 1 and 3	time between the baseline and year 3, average 3 years

Collaborators and Investigators

• Sponsor: Brooklyn College of the City University of New York
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Department of Health and Human Services

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2014
• Primary Completion (ACTUAL): April 30, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: February 18, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (ACTUAL): March 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: stroke; nutrition; epidemiology; Coronary heart disease; postmenopausal women; dietary intake; chocolate consumption
• Additional Relevant MeSH Terms: Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Heart Diseases; Stroke; Cardiovascular Diseases
• Other Study ID Numbers: 438347-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No