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Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women.
Am J Clin Nutr. 2011 Feb; 93(2):356-67.AJ

Abstract

BACKGROUND

Soy isoflavones are naturally occurring phytochemicals with weak estrogenic cellular effects. Despite numerous clinical trials of short-term isoflavone supplementation, there is a paucity of data regarding longer-term outcomes and safety.

OBJECTIVE

Our aim was to evaluate the clinical outcomes of soy hypocotyl isoflavone supplementation in healthy menopausal women as a secondary outcome of a trial on bone health.

DESIGN

A multicenter, randomized, double-blind, placebo-controlled 24-mo trial was conducted to assess the effects of daily supplementation with 80 or 120 mg aglycone equivalent soy hypocotyl isoflavones plus calcium and vitamin D on the health of 403 postmenopausal women. At baseline and after 1 and 2 y, clinical blood chemistry values were measured and a well-woman examination was conducted, which included a mammogram and a Papanicolaou test. A cohort also underwent transvaginal ultrasound measurements to assess endometrial thickness and fibroids.

RESULTS

The baseline characteristics of the groups were similar. After 2 y of daily isoflavone exposure, all clinical chemistry values remained within the normal range. The only variable that changed significantly was blood urea nitrogen, which increased significantly after 2 y (P = 0.048) but not after 1 y (P = 0.343) in the supplementation groups. Isoflavone supplementation did not affect blood lymphocyte or serum free thyroxine concentrations. No significant differences in endometrial thickness or fibroids were observed between the groups. Two serious adverse events were detected (one case of breast cancer and one case of estrogen receptor-negative endometrial cancer), which was less than the expected population rate for these cancers.

CONCLUSION

Daily supplementation for 2 y with 80-120 mg soy hypocotyl isoflavones has minimal risk in healthy menopausal women. This trial was registered at clinicaltrials.gov as NCT00665860.

Authors+Show Affiliations

Department of Nutrition, University of California, Davis, CA 95616, USA. fmsteinberg@ucdavis.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

21177797

Citation

Steinberg, Francene M., et al. "Clinical Outcomes of a 2-y Soy Isoflavone Supplementation in Menopausal Women." The American Journal of Clinical Nutrition, vol. 93, no. 2, 2011, pp. 356-67.
Steinberg FM, Murray MJ, Lewis RD, et al. Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women. Am J Clin Nutr. 2011;93(2):356-67.
Steinberg, F. M., Murray, M. J., Lewis, R. D., Cramer, M. A., Amato, P., Young, R. L., Barnes, S., Konzelmann, K. L., Fischer, J. G., Ellis, K. J., Shypailo, R. J., Fraley, J. K., Smith, E. O., & Wong, W. W. (2011). Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women. The American Journal of Clinical Nutrition, 93(2), 356-67. https://doi.org/10.3945/ajcn.110.008359
Steinberg FM, et al. Clinical Outcomes of a 2-y Soy Isoflavone Supplementation in Menopausal Women. Am J Clin Nutr. 2011;93(2):356-67. PubMed PMID: 21177797.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women. AU - Steinberg,Francene M, AU - Murray,Michael J, AU - Lewis,Richard D, AU - Cramer,Margaret A, AU - Amato,Paula, AU - Young,Ronald L, AU - Barnes,Stephen, AU - Konzelmann,Karen L, AU - Fischer,Joan G, AU - Ellis,Kenneth J, AU - Shypailo,Roman J, AU - Fraley,J Kennard, AU - Smith,E O'Brian, AU - Wong,William W, Y1 - 2010/12/22/ PY - 2010/12/24/entrez PY - 2010/12/24/pubmed PY - 2011/2/26/medline SP - 356 EP - 67 JF - The American journal of clinical nutrition JO - Am. J. Clin. Nutr. VL - 93 IS - 2 N2 - BACKGROUND: Soy isoflavones are naturally occurring phytochemicals with weak estrogenic cellular effects. Despite numerous clinical trials of short-term isoflavone supplementation, there is a paucity of data regarding longer-term outcomes and safety. OBJECTIVE: Our aim was to evaluate the clinical outcomes of soy hypocotyl isoflavone supplementation in healthy menopausal women as a secondary outcome of a trial on bone health. DESIGN: A multicenter, randomized, double-blind, placebo-controlled 24-mo trial was conducted to assess the effects of daily supplementation with 80 or 120 mg aglycone equivalent soy hypocotyl isoflavones plus calcium and vitamin D on the health of 403 postmenopausal women. At baseline and after 1 and 2 y, clinical blood chemistry values were measured and a well-woman examination was conducted, which included a mammogram and a Papanicolaou test. A cohort also underwent transvaginal ultrasound measurements to assess endometrial thickness and fibroids. RESULTS: The baseline characteristics of the groups were similar. After 2 y of daily isoflavone exposure, all clinical chemistry values remained within the normal range. The only variable that changed significantly was blood urea nitrogen, which increased significantly after 2 y (P = 0.048) but not after 1 y (P = 0.343) in the supplementation groups. Isoflavone supplementation did not affect blood lymphocyte or serum free thyroxine concentrations. No significant differences in endometrial thickness or fibroids were observed between the groups. Two serious adverse events were detected (one case of breast cancer and one case of estrogen receptor-negative endometrial cancer), which was less than the expected population rate for these cancers. CONCLUSION: Daily supplementation for 2 y with 80-120 mg soy hypocotyl isoflavones has minimal risk in healthy menopausal women. This trial was registered at clinicaltrials.gov as NCT00665860. SN - 1938-3207 UR - https://www.unboundmedicine.com/medline/citation/21177797/Clinical_outcomes_of_a_2_y_soy_isoflavone_supplementation_in_menopausal_women_ L2 - https://academic.oup.com/ajcn/article-lookup/doi/10.3945/ajcn.110.008359 DB - PRIME DP - Unbound Medicine ER -