Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000598
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
1999-10-27
Brief Title:
Diet and Exercise for Elevated Risk DEER
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
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 determine the effect in men and postmenopausal women with elevated LDL-cholesterol and low HDL-cholesterol of an exercise regimen with or without the National Cholesterol Education Program NCEP Step Two diet compared to usual care control group on HDL- and LDL-cholesterol
Detailed Description:
BACKGROUND
The NCEP is a major public education program providing advice to physicians and the public on management and prevention of coronary heart disease However data supporting the advice are derived primarily from middle-aged men with less data available for women and older individuals Furthermore there have been recent reports that when low saturated fat diets such as the NCEP Step One and NCEP Step Two diets are followed HDL-cholesterol is lowered as well as LDL-cholesterol
DESIGN NARRATIVE
Randomized controlled factorial design powered for men and women separately One hundred eighty postmenopausal women 45 through 64 years of age and 197 men 30 through 64 years of age who had low high-density lipoprotein HDL cholesterol levels or 59 mg per deciliter in women and or 44 mg per deciliter in men and moderately elevated levels of low-density lipoprotein LDL cholesterol 125 mg per deciliter but 210 mg per deciliter in women and 125 mg per deciliter but 190 mg per deciliter in men were enrolled The subjects were randomly assigned to aerobic exercise the NCEP Step 2 diet or diet plus exercise or to a control group which received no intervention The four interventions were delivered for one year usual care written dietary materials only with delayed intervention optional exercise only supervised progressive aerobic exercise program at least three times per week diet only group and individual dietary instruction on the NCEP Step OneStep Two diet delivered by registered dietitians and diet plus exercise At baseline and at the end of one year measurements were made of blood lipids and lipoproteins plasma glucose and insulin glucose tolerance blood pressure body composition through hydrostatic weighing and waist and hip circumterences aerobic fitness VO2 max and five unannounced 24-hr recalls The primary outcomes measured was HDL-cholesterol major secondary endpoints included LDL-C LDL-CHDL-C ratio and triglycerides
The NCEP is a major public education program providing advice to physicians and the public on management and prevention of coronary heart disease However data supporting the advice are derived primarily from middle-aged men with less data available for women and older individuals Furthermore there have been recent reports that when low saturated fat diets such as the NCEP Step One and NCEP Step Two diets are followed HDL-cholesterol is lowered as well as LDL-cholesterol
DESIGN NARRATIVE
Randomized controlled factorial design powered for men and women separately One hundred eighty postmenopausal women 45 through 64 years of age and 197 men 30 through 64 years of age who had low high-density lipoprotein HDL cholesterol levels or 59 mg per deciliter in women and or 44 mg per deciliter in men and moderately elevated levels of low-density lipoprotein LDL cholesterol 125 mg per deciliter but 210 mg per deciliter in women and 125 mg per deciliter but 190 mg per deciliter in men were enrolled The subjects were randomly assigned to aerobic exercise the NCEP Step 2 diet or diet plus exercise or to a control group which received no intervention The four interventions were delivered for one year usual care written dietary materials only with delayed intervention optional exercise only supervised progressive aerobic exercise program at least three times per week diet only group and individual dietary instruction on the NCEP Step OneStep Two diet delivered by registered dietitians and diet plus exercise At baseline and at the end of one year measurements were made of blood lipids and lipoproteins plasma glucose and insulin glucose tolerance blood pressure body composition through hydrostatic weighing and waist and hip circumterences aerobic fitness VO2 max and five unannounced 24-hr recalls The primary outcomes measured was HDL-cholesterol major secondary endpoints included LDL-C LDL-CHDL-C ratio and triglycerides
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 |
|---|---|---|---|
| R01HL045733 | NIH | None | httpsreporternihgovquickSearchR01HL045733 |