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Flavonoids and Cardiovascular Disease

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 16, 2000
    Last Updated
    March 15, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006504
    Brief Title
    Flavonoids and Cardiovascular Disease
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    August 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To determine the association between flavonoids intake and the prevention of incident cardiovascular disease (CVD).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Myocardial Infarction, Coronary Disease

    7. Study Design

    10. Eligibility

    Sex
    All
    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
    Howard Sesso
    Organizational Affiliation
    Brigham and Women's Hospital

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12840203
    Citation
    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.
    Results Reference
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    PubMed Identifier
    12791616
    Citation
    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.
    Results Reference
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    Flavonoids and Cardiovascular Disease

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