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Dietary Treatment of Hyperlipidemia in Women Vs. Men
This study has been completed.
Study NCT00005336   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes

May 25, 2000
June 23, 2005
April 1991
 
 
 
Complete list of historical versions of study NCT00005336 on ClinicalTrials.gov Archive Site
 
 
 
Dietary Treatment of Hyperlipidemia in Women Vs. Men
 

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.

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?

 
Observational
Natural History, Longitudinal
  • Cardiovascular Diseases
  • Heart Diseases
  • Hypercholesterolemia
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
September 1996
 

No eligibility criteria

Male
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00005336
 
4195
National Heart, Lung, and Blood Institute (NHLBI)
 
 
National Heart, Lung, and Blood Institute (NHLBI)
April 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP