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
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005336
First Posted
May 25, 2000
Last Updated
February 8, 2016
Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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
Learn more about this trial
Dietary Treatment of Hyperlipidemia in Women vs. Men
We'll reach out to this number within 24 hrs