Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201162
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2005-09-16
Brief Title:
Soy and Lipoproteins in Postmenopausal Women
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Soy and Lipoproteins in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2018-08
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 effects of soy on lipids lipoproteins and lipoprotein subclass in a sample of African-American and white postmenopausal women with low-density lipoprotein LDL cholesterol elevations that may increase their lifetime risk for cardiovascular disease but would not qualify for definite pharmacotherapy under current guidelines
Detailed Description:
BACKGROUND
Cardiovascular disease CVD remains the leading cause of mortality and disability in postmenopausal women Menopause alters serum lipids and lipoproteins to produce a more atherogenic lipid profile that may contribute significantly to the increased risk for the development of CVD over the lifetime of women Clinical trials have demonstrated a beneficial effect of soy protein containing isoflavones soy on plasma lipids and lipoproteins however these studies included small numbers of postmenopausal women and virtually none included sufficient African-American women In addition no published data existed in 2001 on the impact of soy on atherogenic lipoprotein subclasses in postmenopausal women
DESIGN NARRATIVE
The study was a double blind parallel group randomized clinical trial A total of 216 healthy postmenopausal women 50 percent African-American with LDL cholesterol between 130 mgdL and 190 mgdL were enrolled Following a pre-randomization run-in period on a NCEP Step I diet women were randomized to receive soy containing isoflavones or casein dietary supplements for 3 months Major outcome variables were assessed in both groups at baseline and again at 3 months It was hypothesized that soy supplementation would result in significantly greater reduction in LDL cholesterol LDL particle concentration and prevalence of dense LDL particles and improvement in menopausal quality of life compared with placebo and that these effects would be comparable in African-Americans and whites This was the first study to determine whether a natural plant product could ameliorate the unfavorable changes in known and novel lipid risk factors that are a consequence of menopause in both African-American and white women The unique transitional outcomes explored in this study added substantially to the limited body of knowledge of the effects of soy Evaluation of this nutritional alternative to hormone replacement therapy HRT that may provide a beneficial effect on lipid risk factors and menopausal symptoms but would be free of the adverse effects on triglycerides the breast and uterus and thrombotic events associated with HRT could have significant public health implications for postmenopausal women
Cardiovascular disease CVD remains the leading cause of mortality and disability in postmenopausal women Menopause alters serum lipids and lipoproteins to produce a more atherogenic lipid profile that may contribute significantly to the increased risk for the development of CVD over the lifetime of women Clinical trials have demonstrated a beneficial effect of soy protein containing isoflavones soy on plasma lipids and lipoproteins however these studies included small numbers of postmenopausal women and virtually none included sufficient African-American women In addition no published data existed in 2001 on the impact of soy on atherogenic lipoprotein subclasses in postmenopausal women
DESIGN NARRATIVE
The study was a double blind parallel group randomized clinical trial A total of 216 healthy postmenopausal women 50 percent African-American with LDL cholesterol between 130 mgdL and 190 mgdL were enrolled Following a pre-randomization run-in period on a NCEP Step I diet women were randomized to receive soy containing isoflavones or casein dietary supplements for 3 months Major outcome variables were assessed in both groups at baseline and again at 3 months It was hypothesized that soy supplementation would result in significantly greater reduction in LDL cholesterol LDL particle concentration and prevalence of dense LDL particles and improvement in menopausal quality of life compared with placebo and that these effects would be comparable in African-Americans and whites This was the first study to determine whether a natural plant product could ameliorate the unfavorable changes in known and novel lipid risk factors that are a consequence of menopause in both African-American and white women The unique transitional outcomes explored in this study added substantially to the limited body of knowledge of the effects of soy Evaluation of this nutritional alternative to hormone replacement therapy HRT that may provide a beneficial effect on lipid risk factors and menopausal symptoms but would be free of the adverse effects on triglycerides the breast and uterus and thrombotic events associated with HRT could have significant public health implications for postmenopausal women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070553 | NIH | None | httpsreporternihgovquickSearchR01HL070553 |