Tufts University
Boston, Massachusetts, 02111, United States
NCT Number: NCT01864122
The overall objective of this research proposal is to determine whether the predictive value of using plasma concentrations of selected nutrient biomarkers of food intake determined using a single plasma sample either alone or in combination are stronger, objective predictors of subsequent death from coronary heart disease (CHD) or myocardial infarct (MI) compared to selected food intake data derived from subjective, self-reported food frequency questionnaires.
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Notify Me65 year and older
Female
Observational
Boston, Massachusetts, 02111, United States
The overall objective is to determine whether the predictive value of plasma concentrations of selected nutrient biomarker(s) of food intake determined using a single plasma sample either alone or in combination are stronger, objective predictors of subsequent death from CHD or MI compared to selected food intake data derived from subjective, self-reported food frequency questionnaires. The nutrient biomarkers (phospholipid [PL] eicosapentaenoic acid [EPA], PL docosahexaenoic acid [DHA], PL trans fatty acids, phylloquinone, dihydrophylloquinone) and foods (fish, dark fish and tuna, vegetables, fruits, and whole grains, and unsaturated fat rich foods) targeted have previously been either directly or indirectly associated with CVD risk. We propose to test our overall objective by conducting a nested case-control study using plasma samples and food frequency data from the observational cohort of the Women's Health Initiative (WHI). Our cases (n=1200) will be selected from the subset of women who did not report dietary supplement use and who died of CHD or MI (collectively referred to as WHI CHD cases). The control subjects (n=1200) will be selected from the subset that were free of CHD or MI events and matched with cases for standard National Cholesterol Education Program (NCEP) risk factors (WHI controls). Nutrient biomarker data will be newly generated using stored specimens whereas the selected food intake data have previously been collected by the WHI investigators.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Cases, defined as women with centrally confirmed CHD and fatal or non-fatal myocardial infarction (MI).
Control subjects were matched on the basis of age, enrollment date, race/ethnicity and absence of CHD, MI, angina, coronary artery by-pass graft/ percutaneous transluminal coronary angioplasty, congestive heart failure, stroke or peripheral vascular disease at baseline.
Exclusion criteria
none
Time frame: 4 years
phospholipid fatty acid profiles
Time frame: 2 years
analysis of data generated from self-reported food questionnaire, documenting types and amounts and frequency of foods consumed
Time frame: 4 years
quantification of phylloquinones
Time frame: 4 years
quantification of dihydrophylloquinones
Time frame: 4 years
determination of desaturase indexes
Time frame: 4 years
quantification of carotenoids
Tufts University
Other
Acronym: WHI
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