Chocolate and CVD Risk in Postmenopausal Women

Brooklyn College of the City University of New York

Status: Completed

Conditions: Stroke; Heart Disease; Cardiovascular Disease

Treatments: Behavioral: chocolate consumption level; Other: physician diagnosis of first occurrence of serious chronic disease

Study type: Observational

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT03453073

438347-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83,310 patients

Sex: Female

Ages: 55 to 79 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

83,310 participants in 9 patient groups

chocolate consumption level referent

Description:

women who ate 1 oz. (28.35 g) of chocolate \<1 time/month

Treatment:

Behavioral: chocolate consumption level

chocolate consumption level 2

Description:

women who ate 1 oz. (28.35 g) of chocolate between 1 and \<1.5 times/month

Treatment:

Behavioral: chocolate consumption level

chocolate consumption level 3

Description:

women who ate 1 oz. (28.35 g) of chocolate between 1.5 and \<3.5 times/month,

Treatment:

Behavioral: chocolate consumption level

chocolate consumption level 4

Description:

women who ate 1 oz. (28.35 g) of chocolate between 3.5 times/month and \<3 times/week

Treatment:

Behavioral: chocolate consumption level

chocolate consumption level 5

Description:

women who ate 1 oz. (28.35 g) of chocolate \>3 times/week

Treatment:

Behavioral: chocolate consumption level

No physician diagnosis

Description:

No incidence of serious chronic disease prior to visit 3

Treatment:

Other: physician diagnosis of first occurrence of serious chronic disease

Physician diagnosis

Description:

Incidence of serious chronic disease prior to visit 3

Treatment:

Other: physician diagnosis of first occurrence of serious chronic disease

Younger

Description:

Age\<65 years at follow-up baseline

Treatment:

Behavioral: chocolate consumption level

Older

Description:

Age\>=65 years at follow-up baseline

Treatment:

Behavioral: chocolate consumption level