- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006504
Flavonoids and Cardiovascular Disease
Study Overview
Status
Detailed Description
BACKGROUND:
Basic science, clinical observation, and epidemiologic studies have all contributed to an emerging body of evidence on the potential role of flavonoids, a group of polyphenolic compounds with antioxidant properties, in the prevention of cardiovascular disease. However, the few existing studies on flavonoids or its food sources have provided inconsistent results, usually focusing on the primary prevention of coronary heart disease mortality. The study used the small grant mechanism (R03) to analyze previously collected data.
DESIGN NARRATIVE:
The investigators examined whether flavonoid intake was associated with the risk of incident CVD, and whether specific food sources of flavonoids--including tea, onions, apples, red wine, and other foods--were associated with the risk of incident CVD. The investigators processed and analyzed previously collected data of 39,876 middle-aged and older women free of CVD; the Women's Antioxidant Cardiovascular Study (WACS), a prospective study of 8,171 middle-aged and older women with pre-existing CVD or more than three coronary risk factors; the Normative Aging Study (NAS), a prospective study of 2,280 middle-aged and older men; and the Boston Area Health Study (BAHS), a case-control study of first nonfatal myocardial infarction in men and women aged less than 76 years. Using data from semiquantitative food frequency questionnaires administered in each study, the investigators determined individual intake of flavonoids and its food sources. Unlike previous studies, they examined flavonoids in relation to both the primary and secondary prevention of incident cardiovascular disease (CVD), consisting of confirmed cases of nonfatal myocardial infarction (Ml), nonfatal stroke, revascularization procedures, and CVD death.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Collaborators and Investigators
Investigators
- Howard Sesso, Brigham and Women's Hospital
Publications and helpful links
General Publications
- Sesso HD, Gaziano JM, Liu S, Buring JE. Flavonoid intake and the risk of cardiovascular disease in women. Am J Clin Nutr. 2003 Jun;77(6):1400-8. doi: 10.1093/ajcn/77.6.1400.
- Sesso HD, Liu S, Gaziano JM, Buring JE. Dietary lycopene, tomato-based food products and cardiovascular disease in women. J Nutr. 2003 Jul;133(7):2336-41. doi: 10.1093/jn/133.7.2336.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 945
- R03HL065727 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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