The purpose of the BEST Study was to find if soy supplements could lower cholesterol in post menopausal women.
Meet the Investigators
The purpose of this study was to determine the effects of soy protein with isoflavones on lipids, lipoproteins, lipoprotein subclasses, and menopausal quality of life, including menopausal symptoms, in African American and white postmenopausal women with borderline to moderate LDL-C elevations.
We found that soy protein containing isoflavones improved atherogenic lipoprotein profiles in postmenopausal women, and decreased LDL particle number, a strong predictor of disease progression and incident CHD events. Soy protein alone does not lower blood cholesterol with the same effectiveness as cholesterol lowering medications; however, soy protein’s modest effect on LDL cholesterol and LDL particle number may be beneficial for heart health in postmenopausal women who do not qualify for definitive pharmacotherapy.
This was 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.
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 (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 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.
Appling, S, Paez, K, Allen, JK, (2007). Ethnicity and Vasomotor Symptoms in Postmenopausal Women. Journal of Women's Health (16), 1130-1138
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
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).
November, 2001 Allen, J.K. Soy and Lipoproteins in Post-menopausalWomen. American Heart Association Scientific Sessions. Anaheim, CA
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, Kwiterovich P, Paez K, Szanton S, Lindenstruth K, Curtis C. (2005) Soy Improves Lipoprotein Particle Number in Postmenopausal Women. [Abstract] Circulation, 112(17), II-529
Allen JK, Scott LB, Curtis C, Lavis A. (2003) Disparities in referral and enrollment of women in cardiac rehabilitation programs. [Abstract] Circulation, 108(17), IV-382
Allen JK, Kelly K, Blumenthal RS, Margolis S, Young DR, Curtis C, Lavis A. (2002) Nurse case management of hypercholesterolemia is cost-effective. [Abstract] Circulation, 106(19), ii-369
Allen JK, Becker D, Appling S, Kelly K. (2001) Soy and lipoproteins in postmenopausal women. [Abstract] Circulation, 104(17), ii-470
Allen J, Blumenthal RS, Margolis S, Young DR, Rohde C, Kelly K. (2000) Nurse case management compared with usual physician care for lipid management following revascularization. [Abstract] Circulation, 102(18), II-749
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
November 2005 Allen JK, Becker D, Kwiterovich P, Paez K, Szanton S, Lindenstruth K, Curtis C. Soy Improves Lipoprotein Particle Number in Postmenopausal Women. American Heart Association Annual Scientific Sessions. Dallas, TX
September 2005 Paez, KA, Appling, SE, Allen, JK. Differences in Vasomotor Symptoms Between Postmenopausal African-American and White Women. North American Menopause Society Conference, San Diego, CA (poster)
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. American Heart Association 45th Annual Conference on Cardiovascular Disease Epidemiology and Prevention in association with the Council on Nutrition, Physical Activity and Metabolism. Washington, D.C.*
February 2003 Appling, S, Kelly, K, Allen, JK. Impact of Soy on Menopausal Symptoms. Southern Nursing Research Society 17th Annual Conference. Orlando, Florida.
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.
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.