Soy and Lipoproteins in Postmenopausal Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00201162
First received: September 16, 2005
Last updated: March 19, 2014
Last verified: January 2008

September 16, 2005
March 19, 2014
September 2001
August 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00201162 on ClinicalTrials.gov Archive Site
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Soy and Lipoproteins in Postmenopausal Women
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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.

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 160 healthy postmenopausal women (50 percent African-American) with LDL cholesterol between 130 mg/dL and 190 mg/dL 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.

Interventional
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Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
  • Atherosclerosis
  • Cardiovascular Diseases
  • Heart Diseases
  • Menopause
  • Behavioral: diet, soy proteins
  • Behavioral: dietary supplements
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2006
August 2006   (final data collection date for primary outcome measure)

No eligibility criteria

Female
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00201162
280, R01HL070553
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Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Investigator: Jerilyn Allen Johns Hopkins University
Johns Hopkins University
January 2008

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