NCT01864122

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,448

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
Last Updated

May 6, 2025

Status Verified

October 1, 2017

Enrollment Period

3.8 years

First QC Date

May 3, 2013

Last Update Submit

May 1, 2025

Conditions

Keywords

nutrient biomarkersfood frequency questionnairepredictors of CVDfatty acidsphylloquinonedihydrophylloquinone

Outcome Measures

Primary Outcomes (1)

  • plasma markers of dietary intake

    phospholipid fatty acid profiles

    4 years

Secondary Outcomes (5)

  • self-reported food frequency questionnaire data analysis

    2 years

  • phylloquinone

    4 years

  • dihydrophylloquinone

    4 years

  • desaturase indexes

    4 years

  • carotenoids

    4 years

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Womens' Health Initiative Observational Study

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (2)

  • Horn LV, Tian L, Neuhouser ML, Howard BV, Eaton CB, Snetselaar L, Matthan NR, Lichtenstein AH. Dietary patterns are associated with disease risk among participants in the Women's Health Initiative Observational Study. J Nutr. 2012 Feb;142(2):284-91. doi: 10.3945/jn.111.145375. Epub 2011 Dec 21.

    PMID: 22190026BACKGROUND
  • Matthan NR, Ooi EM, Van Horn L, Neuhouser ML, Woodman R, Lichtenstein AH. Plasma phospholipid fatty acid biomarkers of dietary fat quality and endogenous metabolism predict coronary heart disease risk: a nested case-control study within the Women's Health Initiative observational study. J Am Heart Assoc. 2014 Aug 13;3(4):e000764. doi: 10.1161/JAHA.113.000764.

    PMID: 25122663BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Alice H Lichtenstein, D.Sc.

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2013

First Posted

May 29, 2013

Study Start

January 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

May 6, 2025

Record last verified: 2017-10

Locations