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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | April 1991 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005336 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Dietary Treatment of Hyperlipidemia in Women Vs. Men |
| Official Title ICMJE | |
| 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? |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Natural History, Longitudinal |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | September 1996 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00005336 |
| Responsible Party | |
| Study ID Numbers ICMJE | 4195 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | April 2000 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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