Dietary Antioxidants and Atherosclerosis

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005412
• Other study ID #: 4330
• Secondary ID: R03HL047408
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: May 12, 2016
• Start date: July 1992
• Est. completion date: June 1995

Study information

• Verified date: June 2000
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To examine the role of dietary antioxidants in the etiology of atherosclerosis in both sexes and in whites and Blacks.

Description:

BACKGROUND:

Atherosclerosis is this nation's leading cause of death for males and females, and Blacks and whites. There is mounting evidence that the oxidation of blood low density lipoproteins (LDL) plays an important role in the pathogenesis of this disease. LDL oxidation can be prevented by several dietary antioxidants, in particular, vitamin C, vitamin E, and beta-carotene. There is preliminary evidence that dietary antioxidants may slow the natural history of atherosclerosis in humans. Until now studies in this area have included predominantly white males with symptomatic disease.

DESIGN NARRATIVE:

The case-control study used data collected in ARIC to test the hypothesis that individuals in the lowest quintile of vitamin C, vitamin E and carotenoid consumption were at higher risk of asymptomatic atherosclerosis than those consuming greater amounts. Antioxidant intake was assessed by a validated food frequency questionnaire and a diet supplement survey. Cases were those with asymptomatic carotid artery atherosclerosis as determined by B-mode ultrasonography. Controls were those without evidence of carotid artery atherosclerosis. Secondary analyses determined which sex-race subgroups were at particular risk due to low antioxidant consumption.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 1995
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Carotid Stenosis
• Heart Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

Kritchevsky SB, Shimakawa T, Tell GS, Dennis B, Carpenter M, Eckfeldt JH, Peacher-Ryan H, Heiss G. Dietary antioxidants and carotid artery wall thickness. The ARIC Study. Atherosclerosis Risk in Communities Study. Circulation. 1995 Oct 15;92(8):2142-50. — View Citation

Kritchevsky SB, Tell GS, Shimakawa T, Dennis B, Li R, Kohlmeier L, Steere E, Heiss G. Provitamin A carotenoid intake and carotid artery plaques: the Atherosclerosis Risk in Communities Study. Am J Clin Nutr. 1998 Sep;68(3):726-33. — View Citation