Prospective Study of Diet and Cardiovascular Disease
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Coronary Disease
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005519
First Posted
May 25, 2000
Last Updated
May 12, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005519
Brief Title
Prospective Study of Diet and Cardiovascular Disease
Study Type
Observational
2. Study Status
Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To examine associations between various dietary elements and the risk of coronary heart disease and stroke.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Cerebrovascular Accident
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang He
Organizational Affiliation
Tulane University
12. IPD Sharing Statement
Citations:
PubMed Identifier
11295963
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. doi: 10.1001/archinte.161.7.996.
Results Reference
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PubMed Identifier
11718588
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. doi: 10.1001/archinte.161.21.2573.
Results Reference
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PubMed Identifier
10591385
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. doi: 10.1001/jama.282.21.2027.
Results Reference
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PubMed Identifier
11441188
Citation
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. doi: 10.1161/01.str.32.7.1473.
Results Reference
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Prospective Study of Diet and Cardiovascular Disease
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