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Beneficial Effects of Soy Trial

2001-2003 Soy and Lipoproteins in Post-menopausal Women, National Heart Lung and Blood Institute, 1RO1 HL70553-01, $1,053,976, direct costs.

1999-2000 Dietary Soy Supplementation in Postmenopausal Women: A Pilot Study, Fund for Geriatric Medicine and Nursing. Johns Hopkins University.

Principal Investigator: Jerilyn K. Allen, RN, ScD, FAAN
Co-Investigator: Susan Appling, MSN, RN, CRNP
Co-Investigator: Diane M. Becker, RN, ScD
Co-Investigator: Peter Kwiterovich, Jr, MD
Project Coordinator: Carol Curtis

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 life development of CVD over the lifetime of women. Clinical trials have demonstrated a beneficial effect of soy protein containing isoflavones 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 exist on the impact of soy on atherogenic lipoprotein subclasses in postmenopausal women. Therefore, the primary aim of this study is to determine the effects of soy on lipids, lipoproteins and lipoprotein subclasses in a sample of African-American and white postmenopausal women with low-density lipoprotein (LDL) cholesterol elevations that may increase their lifetime risk for CVD but would not qualify for definitive pharmacotherapy under current guidelines. The secondary aims are to assess the impact of soy on menopausal quality of life, including menopausal symptoms, and to examine racial/ethnic differences in quality of life, acceptability, adherence to, and lipoprotein response to the soy supplementation. The proposed study is a double blind, placebo-controlled, parallel group, randomized clinical trial. A total of 160 healthy postmenopausal women (50% African-American) with LDL cholesterol between 130 mg/DL and 190 mg/DL will be enrolled. Following a pre-randomization run-in period on a NCEP Step 1 diet, women will be randomized to receive soy containing isoflavones or casein dietary supplements for 3 months. Major outcome variables will be assessed in both groups at baseline and again at 3 months. It is hypothesized that soy supplementation will 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 will be comparable in African-Americans and Whites. This will be the first study to determine whether a natural plant product can 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 will add 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.

Publications:

Allen, JK, D, Becker, P, Kwiterovich, K. Lindenstruth, C, Curtis. (2007) Effect of Soy Protein Containing Isoflavones on Lipoproteins in Postmenopausal Women. Menopause. Vol. 14, 1

Lindenstruth, K, Curtis, C, Allen, J.K. (2006). Recruitment of African American and White Postmenopausal Women into Clinical Trials: The Beneficial Effects of Soy Trial Experience. Ethnicity and Disease. (16),
938-942

Posters:

November, 2001 Allen, J.K. Soy and Lipoproteins in Post-menopausalWomen. American Heart Association Scientific Sessions. Anaheim, CA

April 2005 Allen, JK, Szanton, S, McGready, J, Lindenstruth, K, Curtis,C. Impact of Obesity on Atherogenic Lipoprotein Subclasses in Healthy African-American and Caucasian Postmenopausal Women. 45th Annual Conference on Cardiovascular Disease Epidemiology and Prevention. Washington DC (poster).

Abstracts:

Allen JK, Szanton S, Lindenstruth K, Curtis C. (2006) Effect of Metabolic Syndrome on Lipoprotein Subclass Particle Size Concentration in Postmenopausal Women. [Abstract] Circulation

Allen JK, Becker D, Appling S, Kelly K. (2001) Soy and lipoproteins in postmenopausal women. [Abstract] Circulation, 104(17), ii-470.

Presentations:

November 2001 Allen, JK, Becker, D, Appling S, Kelly, K. Soy and Lipoproteins in Postmenopausal Women. 74th Annual Scientific Sessions, American Heart Association. Anaheim, CA.

April 2002 Allen, JK, Becker, D, Appling S, Kelly, K. Soy and Lipoproteins in Menopausal Women. Asia Pacific Scientific Forum and 42nd Annual Conference on Cardiovascular Disease Epidemiology and Prevention. Honolulu, Hawaii.

February, 2003 Appling, S, Kelly, K, Allen, JK. Impact of Soy on Menopausal Symptoms. Southern Nursing Research Society 17th Annual Conference. Orlando, Florida.

Allen, JK, Szanton, S, Lindenstruth, K, Curtis, C. (2006). Effect of Metabolic Syndrome on Lipoprotein Subclass Particle Size and Concentration in Postmenopausal Women. American Heart Association Scientific Sessions. Chicago, IL.