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Framingham Nutrition Studies
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Study NCT00005513   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes

May 25, 2000
June 23, 2005
September 1998
 
 
 
Complete list of historical versions of study NCT00005513 on ClinicalTrials.gov Archive Site
 
 
 
Framingham Nutrition Studies
 

To examine hypotheses concerning the relationships between nutrient intake (in particular, specific fatty acids, antioxidant nutrients, and B vitamins), dietary patterns, plasma lipoproteins, and heart disease endpoints in the population-based Framingham Offspring Studies.

DESIGN NARRATIVE:

Longitudinal analyses were conducted on the associations between diet and cardiovascular and cardiopulmonary disease risk in approximately 3,800 Offspring men and women over eight years of follow-up (from 1984 to present). These analyses considered key nutrients as well as newly defined dietary patterns in Framingham men and women. Cross sectional analyses of diet and plasma lipoprotein relationships in Offspring men and women at two examinations (Exam 3, 1984-88; and Exam 5, 1991-94) were also conducted. All analyses evaluated the total (direct and indirect) and joint effects of dietary nutrients. Where appropriate, analyses controlled for plasma nutrient levels (folacin, vitamins B6 and B12 and homocysteine). The influence of potential confounding variables, effect modifiers, and intervening variables that lie in the causal pathway were examined, as appropriate to the statistical model, including traditional cardiovascular disease risk factors and apoE isoform status.

Several existing Framingham data sets were utilized, including comprehensive data sets on nutrient intake, cardiovascular disease risk factors, clinically verified cardiovascular and cardiopulmonary endpoints and other covariates. The Offspring Exam 3 and 5 nutrition data sets included multiple day assessments of dietary intake which improved the ability to detect relationships of interest. The investigators completed the Framingham Food Habit Questionnaire data set for Exam 5; this instrument included important covariates for the analyses (including vitamin supplement use).

 
Observational
Natural History
  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Disease
  • Hypertension
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
July 2002
 

No eligibility criteria

Male
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00005513
 
5031
National Heart, Lung, and Blood Institute (NHLBI)
 
Investigator: Barbara Millen Boston University
National Heart, Lung, and Blood Institute (NHLBI)
August 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP