Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005336
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2000-05-25
Brief Title:
Dietary Treatment of Hyperlipidemia in Women vs Men
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 45 and 105 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
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 45 and 105 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL044878 | NIH | None | httpsreporternihgovquickSearchR01HL044878 |