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Dietary Treatment of Hyperlipidemia in Women vs. Men

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
University of Washington
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
    February 8, 2016
    Sponsor
    University of Washington
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005336
    Brief Title
    Dietary Treatment of Hyperlipidemia in Women vs. Men
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    April 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1991 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 1996 (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To conduct a dietary intervention trial to test the lipid lowering response to the National Cholesterol Education Program (NCEP) Step Two Diet by free-living hyperlipidemic women and men and to compare the response between them.
    Detailed Description
    BACKGROUND: Women experience as much illness from hardening of the arteries including stroke and heart disease as do men, but because women experience them later in life, the importance of heart disease, cholesterol, and diet for women has been under appreciated. DESIGN NARRATIVE: Half of the subjects were randomized to diet instruction with two years of follow-up and half to six months of no intervention followed by the same diet instruction and followup. Control subjects had a fasting blood drawn at three months of the nonintervention period. Having parallel intervention and control groups was necessary to test the efficacy of the NCEP Step Two Diet: The diet was taught to study subjects during eight weekly two hour classes. Follow-up included four individual visits, at three, six, nine, and twelve months, with a dietitian and two group sessions, at 4.5 and 10.5 months, in the first year and two individual visits, at 18 and 24 months, in the second year. Fasting blood samples for lipoprotein lipid analysis and 4-day food diaries were collected at all individual visits. Additionally, medical history, lifestyle characteristics, vital signs, other adherence measures, behavioral factors related to adherence, and serum nutrients for monitoring nutrient sufficiency were collected. Dietitians provided adherence and dietary modification counseling as necessary to help participants maximize their adherence. The primary questions to be answered were: 1) Did the NCEP Step Two Diet effectively lower plasma lipids in hypercholesterolemic (HC) and combined hyperlipidemic (CHL) women and men over six months? 2) Did HC and CHL women have a different response than HC and CHL men? 3) Was response in women influenced by menstrual status and sex hormone exposure?, and 4) Were the behavioral adaptations to dietary modification different between women and men?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9013434
    Citation
    Retzlaff BM, Walden CE, McNeney WB, Buck BL, McCann BS, Knopp RH. Nutritional intake of women and men on the NCEP Step I and Step II diets. J Am Coll Nutr. 1997 Feb;16(1):52-61. doi: 10.1080/07315724.1997.10718649.
    Results Reference
    background
    PubMed Identifier
    9081694
    Citation
    Walden CE, Retzlaff BM, Buck BL, McCann BS, Knopp RH. Lipoprotein lipid response to the National Cholesterol Education Program step II diet by hypercholesterolemic and combined hyperlipidemic women and men. Arterioscler Thromb Vasc Biol. 1997 Feb;17(2):375-82. doi: 10.1161/01.atv.17.2.375.
    Results Reference
    background
    PubMed Identifier
    8788542
    Citation
    McCann BS, Bovbjerg VE, Curry SJ, Retzlaff BM, Walden CE, Knopp RH. Predicting participation in a dietary intervention to lower cholesterol among individuals with hyperlipidemia. Health Psychol. 1996 Jan;15(1):61-4. doi: 10.1037//0278-6133.15.1.61.
    Results Reference
    background
    PubMed Identifier
    9103094
    Citation
    Retzlaff BM, Dowdy AA, Walden CE, Bovbjerg VE, Knopp RH. The Northwest Lipid Research Clinic Fat Intake Scale: validation and utility. Am J Public Health. 1997 Feb;87(2):181-5. doi: 10.2105/ajph.87.2.181.
    Results Reference
    background

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