Hypertension Clinical Trial
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).
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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