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Framingham Nutrition Studies

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Coronary Disease

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)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005513
    Brief Title
    Framingham Nutrition Studies
    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
    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 examine hypotheses concerning the relationships between nutrient intake (in particular, specific fatty acids, antioxidant nutrients, and B vitamins), dietary patterns, plasma lipoproteins, and heart disease endpoints in the population-based Framingham Offspring Studies.
    Detailed Description
    DESIGN NARRATIVE: Longitudinal analyses were conducted on the associations between diet and cardiovascular and cardiopulmonary disease risk in approximately 3,800 Offspring men and women over eight years of follow-up (from 1984 to present). These analyses considered key nutrients as well as newly defined dietary patterns in Framingham men and women. Cross sectional analyses of diet and plasma lipoprotein relationships in Offspring men and women at two examinations (Exam 3, 1984-88; and Exam 5, 1991-94) were also conducted. All analyses evaluated the total (direct and indirect) and joint effects of dietary nutrients. Where appropriate, analyses controlled for plasma nutrient levels (folacin, vitamins B6 and B12 and homocysteine). The influence of potential confounding variables, effect modifiers, and intervening variables that lie in the causal pathway were examined, as appropriate to the statistical model, including traditional cardiovascular disease risk factors and apoE isoform status. Several existing Framingham data sets were utilized, including comprehensive data sets on nutrient intake, cardiovascular disease risk factors, clinically verified cardiovascular and cardiopulmonary endpoints and other covariates. The Offspring Exam 3 and 5 nutrition data sets included multiple day assessments of dietary intake which improved the ability to detect relationships of interest. The investigators completed the Framingham Food Habit Questionnaire data set for Exam 5; this instrument included important covariates for the analyses (including vitamin supplement use). 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, Hypertension

    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
    Barbara Millen
    Organizational Affiliation
    Boston University

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11271691
    Citation
    Millen BE, Quatromoni PA, Copenhafer DL, Demissie S, O'Horo CE, D'Agostino RB. Validation of a dietary pattern approach for evaluating nutritional risk: the Framingham Nutrition Studies. J Am Diet Assoc. 2001 Feb;101(2):187-94. doi: 10.1016/s0002-8223(01)00051-7.
    Results Reference
    background
    PubMed Identifier
    11458282
    Citation
    Millen BE, Quatromoni PA. Nutritional research within the Framingham Heart Study. J Nutr Health Aging. 2001;5(3):139-43.
    Results Reference
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    PubMed Identifier
    11964437
    Citation
    Quatromoni PA, Copenhafer DL, Demissie S, D'Agostino RB, O'Horo CE, Nam BH, Millen BE. The internal validity of a dietary pattern analysis. The Framingham Nutrition Studies. J Epidemiol Community Health. 2002 May;56(5):381-8. doi: 10.1136/jech.56.5.381.
    Results Reference
    background
    PubMed Identifier
    12460521
    Citation
    Millen BE, Quatromoni PA, Nam BH, O'Horo CE, Polak JF, D'Agostino RB. Dietary patterns and the odds of carotid atherosclerosis in women: the Framingham Nutrition Studies. Prev Med. 2002 Dec;35(6):540-7. doi: 10.1006/pmed.2002.1116.
    Results Reference
    background

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    Framingham Nutrition Studies

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