Chocolate and CVD Risk in Postmenopausal Women

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453073
• Other study ID #: 438347-3
• Status: Completed
• Start date: December 15, 2014
• Est. completion date: July 1, 2018

Study information

• Verified date: November 2020
• Source: Brooklyn College of the City University of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83310
• Est. completion date: July 1, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Heart Disease
• Heart Diseases
• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Brooklyn College of the City University of New York	Department of Health and Human Services, National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	change in chocolate intake	change in chocolate intake between visit 1 and 3	time between the baseline and visit 3, average 3 years
Primary	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
Primary	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
Primary	change in BMI	change in BMI between visit 1 and 3	time between the baseline and year 3, average 3 years