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CompletedNCT00005226Updated Feb 25, 2016

Epidemiology of Plasma Fatty Acids and Atherosclerosis

An observational study in Atherosclerosis, Cardiovascular Diseases and Heart Diseases, sponsored by University of Minnesota. Completed. Open to male participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2016-02-25.

Sponsored by University of Minnesota · Observational

Study type
Observational
Ages
Up to 100 Years
Sex
Male
01

Study summary

To measure by gas-liquid chromatography the relative concentrations of all saturated and unsaturated fatty acids found in the cholesterol ester and phospholipid fractions of plasma from 4,000 subjects participating in the Atherosclerosis Risk in Communities (ARIC) study. The data were used to clarify the role of various fatty acids in atherosclerosis.

Read the detailed description

BACKGROUND:

The ARIC study is a large population-based, prospective, multicenter study supported by NHLBI which began in 1986, and is designed to investigate the etiology and natural history of atherosclerosis and cardiovascular risk factors. It involves investigation of four cohorts, each with 4,000 adults ages 45 to 65 from four different communities. The study conducts surveillance for hospitalized myocardial infarction, fatal cardiovascular disease, and stroke in its cohorts and of the community from which they are drawn. Events are classified by a Morbidity and Mortality Classification Committee using standardized criteria.

Data collected on the ARIC cohort at baseline included: a clinical history, a physical examination including blood pressure, height, weight, and anthropometry. A second history and physical examination were performed after three years, and annual telephone interviews were conducted in the intervening years. Laboratory studies at baseline and at three years included: electrocardiogram, pulmonary function tests, ultrasonographic examination of both carotids and one popliteal artery for direct visualization of the atherosclerotic process in peripheral large vessels, and numerous blood studies. Certain hemostatic and lipid tests were performed only in 'cases' with ultrasonographically determined carotid atherosclerosis and matched normal 'controls.'

The ARIC clinical history did collect some dietary history using the Willett Questionnaire, and asked a few questions regarding fish consumption. However, specific questions were brief and only semi-quantitative. Direct measurement of plasma fatty acid content as an ancillary study in the Minnesota cohort of the ARIC study gave far more objective information on specific fatty acid consumption and was invaluable in sorting out the true role that various fatty acids play in the prevention of coronary heart disease. Furthermore, measurement of plasma fatty acids in Minnesota ARIC subjects allowed investigation of the relationships between plasma fatty acids composition and the vast amount of laboratory and clinical outcome data which the ARIC study collected. Because the clinical and other laboratory data for each ARIC participant were already available in the computerized data base, a tremendous amount of valuable information was derived on plasma fatty acid relationships with laboratory findings and clinical outcome in a large, randomly selected United States population.

DESIGN NARRATIVE:

The studies were ancillary to the ARIC study. A cross-sectional study examined the association of plasma fatty acids with plasma lipids, hemostatic parameters, and blood pressure. A nested case-control study examined the association of plasma fatty acids in 75 Minnesota cases with carotid atherosclerosis versus 75 normal matched controls. A third study examined the association of plasma fatty acids with incident clinical cardiovascular events, namely myocardial infarction and stroke.

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Conditions studied

  • Atherosclerosis
  • Cardiovascular Diseases
  • Heart Diseases
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

No eligibility criteria

05

Study design

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Ma J, Folsom AR, Lewis L, Eckfeldt JH. Relation of plasma phospholipid and cholesterol ester fatty acid composition to carotid artery intima-media thickness: the Atherosclerosis Risk in Communities (ARIC) Study. Am J Clin Nutr. 1997 Feb;65(2):551-9. doi: 10.1093/ajcn/65.2.551. PubMed 9022543 ↗
  • Ma J, Folsom AR, Eckfeldt JH, Lewis L, Chambless LE. Short- and long-term repeatability of fatty acid composition of human plasma phospholipids and cholesterol esters. The Atherosclerosis Risk in Communities (ARIC) Study Investigators. Am J Clin Nutr. 1995 Sep;62(3):572-8. doi: 10.1093/ajcn/62.3.572. PubMed 7661119 ↗
  • Ma J, Folsom AR, Shahar E, Eckfeldt JH. Plasma fatty acid composition as an indicator of habitual dietary fat intake in middle-aged adults. The Atherosclerosis Risk in Communities (ARIC) Study Investigators. Am J Clin Nutr. 1995 Sep;62(3):564-71. doi: 10.1093/ajcn/62.3.564. PubMed 7661118 ↗
  • Folsom AR, Ma J, Eckfeldt JH, Shahar E, Wu KK. Plasma phospholipid fatty acid composition and factor VII coagulant activity. Atherosclerosis. 1994 Dec;111(2):199-207. doi: 10.1016/0021-9150(94)90094-9. PubMed 7718022 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00005226
Lead sponsor
University of Minnesota
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
First posted
May 26, 2000
Start date
Jul 1988
Completion
Jun 1992
Last update
Feb 25, 2016
View the source record on ClinicalTrials.gov ↗

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