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- Klinische Studie NCT00005336
Dietary Treatment of Hyperlipidemia in Women vs. Men
Studienübersicht
Status
Detaillierte Beschreibung
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?
Studientyp
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Studienplan
Wie ist die Studie aufgebaut?
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
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Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 4195
- R01HL044878 (US NIH Stipendium/Vertrag)
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