Skip to main content
OpenTrials
Completed

NCT Number: NCT03453073

Chocolate and CVD Risk in Postmenopausal Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Disease Heart Disease Heart Diseases Myocardial Ischemia Nervous System Diseases Stroke Vascular Diseases

Age range

55 year–79 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal women
  • age between 50 and 79 years
  • 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

  • implausible energy intakes, defined as <600 kcal/d or >5,000 kcal/d;
  • implausible body mass indices (BMI) (<15 or >50 kg/m2)
  • implausible height<122 cm (4 ft.)
  • 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.
  • missing data on preexisting major chronic disease or any exposure, outcome or confounder variables.

Treatment and study plan

chocolate consumption level

Behavioral

level of consumption of 1 oz. of chocolate, as assessed at baseline

physician diagnosis of first occurrence of serious chronic disease

Other

Primary outcomes

  1. incidence of heart disease

    Time frame: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years

    physician adjudicated first occurrence of, or death due to, heart disease

  2. incidence of stroke

    Time frame: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years

    physician adjudicated first occurrence of, or death due to, stroke

  3. incidence of heart disease or stroke

    Time frame: 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

  4. change in chocolate intake

    Time frame: time between the baseline and visit 3, average 3 years

    change in chocolate intake between visit 1 and 3

  5. change in dietary energy intake

    Time frame: time between the baseline and year 3, average 3 years

    change in dietary energy intake between visit 1 and 3

  6. change in dietary fat intake

    Time frame: time between the baseline and year 3, average 3 years

    change in dietary fat intake between visit 1 and 3

  7. change in BMI

    Time frame: time between the baseline and year 3, average 3 years

    change in BMI between visit 1 and 3

Sponsors and collaborators

Lead sponsor

Brooklyn College of the City University of New York

Other

Collaborators

  • Department of Health and Human Services
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 5, 2018
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.