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Dietary Patterns and Risk of Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT00005514
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : March 20, 2013
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Frank B. Hu, Harvard School of Public Health

Brief Summary:
To study, prospectively, the association between dietary patterns and risk of coronary heart disease (CHD), ischemic stroke, and hemorrhagic stroke in cohort studies of 121,700 women age 30 to 55 years at baseline in 1976 (the Nurses; Health Study; NHS) and 51,529 men aged 40-75 years at baseline in 1986 (the Health Professionals Follow-up Study; HPFS).

Condition or disease
Cardiovascular Diseases Coronary Disease Cerebrovascular Disorders Heart Diseases Cerebrovascular Accident

Detailed Description:


In the first five years of the study analyses were performed on food consumption data collected through semiquantitative food frequency questionnaires at baseline and during follow-up in the Nurses Health Study and Health Professionals Follow-up Study cohorts. Dietary patterns were derived from the food consumption data using factor analysis, cluster analysis, and dietary indexes (based on prevailing dietary recommendations). In addition, using existing datasets from dietary validation studies in sub-samples of the two cohorts, the reproducibility and validity of dietary patterns defined by factor/cluster analysis and dietary indexes were evaluated. Further, using prospectively collected and stored bloods in the NHS (n-32,826) during 1989-1990 and the HPFS (n-18,000) during 1993-1994, the investigators examined whether observed associations between dietary patterns and CHD were explained by (or mediated through) plasma biochemical measurements (including serum lipids, thrombotic factors, antioxidants, fasting insulin, and homocysteine levels) in a nested case-control design; and they assessed prospectively the relationship between dietary patterns and these biomarkers in the control samples.

The study was renewed in 2005 to apply novel statistical methods (such as confirmatory factor analysis and structural equation modeling) to validate various dietary patterns and examine their associations with risk of type 2 diabetes, cardiovascular disease and total mortality in two large ongoing cohort studies, the Nurses' Health Study (n=121,700) and Health Professionals' Follow-up Study (n=51,529). In addition to evaluating prevailing dietary recommendations, the study will also examine the role of the Mediterranean-type dietary pattern, the Dietary Approaches to Stop Hypertension (DASH) dietary pattern, and the Atkins-type diet in predicting health outcomes. Using repeated measurements of diet, the study will examine the impact of changes in eating patterns and diet quality over time on subsequent risk of diabetes, CVD, and total mortality. In addition, it will examine relationships between major dietary patterns and novel plasma biomarkers of inflammation and endothelial function and whether such relationships are mediated through obesity. Finally, the study will test interactions between dietary patterns and individual single nucleotide polymorphisms (SNPs) and haplotypes of several promising candidate genes in the inflammation and endothelial dysfunction pathway on risk of coronary heart disease, including PPARa, PPARy, Adiponectin (AdipoQ), PON1, IL-6, TNF-a, ICAM-1, VCAM-1, E-Selectin, NOS3, ACE gene, and angiotensinogen (ANG) genes.

Study Type : Observational
Actual Enrollment : 120000 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : August 1998
Primary Completion Date : January 2009
Study Completion Date : January 2009

Primary Outcome Measures :
  1. Incident cardiovascular disease [ Time Frame: 1980-2008 ]
    Myocardial infarction, fatal coronary disease, and stroke documented by medical records

Biospecimen Retention:   Samples With DNA
Plasma and buffy coat

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Nurses' Health Study and Health Professionals' Follow-up Study
no history of chronic diseases at baseline


Responsible Party: Frank B. Hu, Professor, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00005514     History of Changes
Other Study ID Numbers: 5032
R01HL060712 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Cerebrovascular Disorders
Myocardial Ischemia
Vascular Diseases
Arterial Occlusive Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases