Prospective Study of Diet and Cardiovascular Disease

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005519
• Other study ID #: 5039
• Secondary ID: R03HL061954
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: May 12, 2016
• Start date: September 1998
• Est. completion date: August 2001

Study information

• Verified date: August 2004
• 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 associations between various dietary elements and the risk of coronary heart disease and stroke.

Description:

BACKGROUND:

Cardiovascular disease is the leading cause of death among residents of the United States. The effect of dietary cholesterol and fat on risk of coronary heart disease (CHD) and stroke has been examined extensively in epidemiologic studies. However, the results from these studies are inconsistent. Furthermore, the association between some other key elements of diet and risk of CHD and stroke has been insufficiently studied in epidemiologic studies.

DESIGN NARRATIVE:

The study examines prospectively the association between: 1) dietary intake of trans-unsaturated fat and the risk of coronary heart disease and 2) dietary intake of total, saturated and unsaturated fats and risk of stroke; 3) dietary intake of vegetable and animal protein and risk of stroke; 4) dietary intake of total and water-soluble fiber and risk of coronary heart disease and stroke; 5) dietary intake of sodium and potassium and risk of coronary heart disease and stroke; 6) dietary intake of vitamin C, carotenoids, vitamin E, and folic acid and the risk of coronary heart disease and stroke; and 7) specific foods, such as fish, beans, fruits, and vegetables and the risk of coronary heart disease and stroke. In addition, the association of baseline serum vitamin A, vitamin C, and folate to the risk of coronary heart disease and stroke will be investigated.

Data from the NHANES1 Epidemiologic Follow-Up Study (NHEFS) will be used to test the hypotheses. The NHEFS is an on-going prospective cohort study being conducted in 14,407 United States men and women aged 25 to 74 years by the National Center for Health Statistics (NCHS). The baseline data, including a 24-hour dietary recall and food frequency questionnaire, as well as important cardiovascular risk factors were collected during 1971-75. The follow-up data were collected during 1982 to 1984, 1986, 1987, and 1992. The follow-up data were obtained by means of an interview, medical records from health care facilities, and death certificates for all decedents. In the study, the investigators will re-code dietary data and calculate dietary nutrients using the ESHA Nutrient Database. They will also analyze the relationship of dietary nutrients and specific foods to risk of CHD and stroke.

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: August 2001
• 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

• Cardiovascular Diseases
• Cerebrovascular Accident
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

References & Publications (4)

Bazzano LA, He J, Ogden LG, Loria C, Vupputuri S, Myers L, Whelton PK. Dietary potassium intake and risk of stroke in US men and women: National Health and Nutrition Examination Survey I epidemiologic follow-up study. Stroke. 2001 Jul;32(7):1473-80. — View Citation

Bazzano LA, He J, Ogden LG, Loria C, Vupputuri S, Myers L, Whelton PK. Legume consumption and risk of coronary heart disease in US men and women: NHANES I Epidemiologic Follow-up Study. Arch Intern Med. 2001 Nov 26;161(21):2573-8. — View Citation

He J, Ogden LG, Bazzano LA, Vupputuri S, Loria C, Whelton PK. Risk factors for congestive heart failure in US men and women: NHANES I epidemiologic follow-up study. Arch Intern Med. 2001 Apr 9;161(7):996-1002. — View Citation

He J, Ogden LG, Vupputuri S, Bazzano LA, Loria C, Whelton PK. Dietary sodium intake and subsequent risk of cardiovascular disease in overweight adults. JAMA. 1999 Dec 1;282(21):2027-34. — View Citation