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Chocolate and CVD Risk in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT03453073
Recruitment Status : Active, not recruiting
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Department of Health and Human Services
Information provided by (Responsible Party):
James Greenberg, Brooklyn College of the City University of New York

Brief 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.

Condition or disease Intervention/treatment
Cardiovascular Disease Heart Disease Stroke 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
Actual Enrollment : 83310 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Chocolate Intake and Heart Disease and Stroke in the Women's Health Initiative: a Prospective Analysis
Actual Study Start Date : December 15, 2014
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   55 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   postmenopausal women 50-79 years of age
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community residents
Criteria

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.

Responsible Party: James Greenberg, Associate Professor, Brooklyn College of the City University of New York
ClinicalTrials.gov Identifier: NCT03453073     History of Changes
Other Study ID Numbers: 438347-3
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James Greenberg, Brooklyn College of the City University of New York:
Coronary heart disease
stroke
chocolate consumption
postmenopausal women
nutrition
dietary intake
epidemiology

Additional relevant MeSH terms:
Stroke
Cardiovascular Diseases
Heart Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases