- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005513
Framingham Nutrition Studies
Study Overview
Status
Detailed Description
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).
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Collaborators and Investigators
Investigators
- Barbara Millen, Boston University
Publications and helpful links
General Publications
- Millen BE, Quatromoni PA, Copenhafer DL, Demissie S, O'Horo CE, D'Agostino RB. Validation of a dietary pattern approach for evaluating nutritional risk: the Framingham Nutrition Studies. J Am Diet Assoc. 2001 Feb;101(2):187-94. doi: 10.1016/s0002-8223(01)00051-7.
- Millen BE, Quatromoni PA. Nutritional research within the Framingham Heart Study. J Nutr Health Aging. 2001;5(3):139-43.
- Quatromoni PA, Copenhafer DL, Demissie S, D'Agostino RB, O'Horo CE, Nam BH, Millen BE. The internal validity of a dietary pattern analysis. The Framingham Nutrition Studies. J Epidemiol Community Health. 2002 May;56(5):381-8. doi: 10.1136/jech.56.5.381.
- Millen BE, Quatromoni PA, Nam BH, O'Horo CE, Polak JF, D'Agostino RB. Dietary patterns and the odds of carotid atherosclerosis in women: the Framingham Nutrition Studies. Prev Med. 2002 Dec;35(6):540-7. doi: 10.1006/pmed.2002.1116.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5031
- R01HL060700 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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