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Trial Information

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.

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

Exclusion Criteria:


Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Outcome Measure:

plasma markers of dietary intake

Outcome Description:

phospholipid fatty acid profiles

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Alice H Lichtenstein, D.Sc.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tufts University


United States: Institutional Review Board

Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Cardiovascular Disease
  • nutrient biomarkers
  • food frequency questionnaire
  • predictors of CVD
  • fatty acids
  • phylloquinone
  • dihydrophylloquinone
  • Cardiovascular Diseases
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Coronary Disease



Tufts University Boston, Massachusetts  02111