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Long-term soy isoflavone supplementation and cognition in women

A randomized, controlled trial

  1. W.J. Mack, PhD For the WISH Research Group
  1. From the Departments of Health Research and Policy (Epidemiology) and Neurology and Neurological Sciences (V.W.H.), Stanford University, Stanford, CA; Atherosclerosis Research Unit (J.A.S., H.N.H., N.K., W.J.M.) and Departments of Preventive Medicine (J.A.S., H.N.H., N.K., W.J.M.), Medicine (H.N.H.), Pharmacy (H.N.H.), and Neurology (C.A.M.), University of Southern California Keck School of Medicine, Los Angeles; and University of Hawaii Cancer Center (A.A.F.), Honolulu, HI.
  1. Correspondence & reprint requests to Dr. Mack: wmack{at}usc.edu
Scientific Advisory Boards:

  1. NONE

Gifts:

  1. NONE

Funding for Travel or Speaker Honoraria:

  1. 1. American Academy of Neurology, speaker honorarium. 2. Endocrine Society, speaker honorarium.

Editorial Boards:

  1. Current editorial advisory board member without compensation: American Journal of Alzheimer’s Disease and Other Dementias (since 1997); Climacteric (since 1998); Cognitive and Behavioral Neurology (since 2003); Menopause (since 2002); Journal of Steroid Biochemistry and Molecular Biology (since 2011); Menopause International (since 2007)

Patents:

  1. NONE

Publishing Royalties:

  1. Hormones, Cognition and Dementia (Cambridge University Press, 2009)

Employment, Commercial Entity:

  1. NONE

Consultancies:

  1. NONE

Speakers’ Bureaus:

  1. NONE

Other Activities:

  1. Dr. Henderson receives honoraria for NIH study section participation.

Clinical Procedures or Imaging Studies:

  1. NONE

Research Support, Commercial Entities:

  1. NONE

Research Support, Government Entities:

  1. 1. National Insitutes of Health, U01 AT00165, co- investigator, 2006-2009 2. National Insitutes of Health, R01AG034639, PI, 2009- present. 3. National Insitutes of Health, N01-WH042109, co- investigator, 2008- present. 4. National Insitutes of Health, N01-WH042109, site co- investigator, 2010-present. 5. National Insitutes of Health, R01-AG023038, PI, 2005- 2011. 6. National Insitutes of Health, R01-AG024154, co- investigator, 2007-2010. 7. National Insitutes of Health, R13-AG03290, co- investigator, 2009-2010.

Research Support, Academic Entities:

  1. NONE

Research Support, Foundations and Societies:

  1. NONE

Stock/Stock Options/Board of Directors Compensation:

  1. NONE

License Fee Payments, Technology or Inventions:

  1. NONE

Royalty Payments, Technology or Inventions:

  1. NONE

Stock/Stock Options, Research Sponsor:

  1. NONE

Stock/Stock Options, Medical Equipment & Materials:

  1. NONE

Legal Proceedings:

  1. NONE

Scientific Advisory Boards:

  1. NONE

Gifts:

  1. NONE

Funding for Travel or Speaker Honoraria:

  1. NONE

Editorial Boards:

  1. NONE

Patents:

  1. NONE

Publishing Royalties:

  1. NONE

Employment, Commercial Entity:

  1. NONE

Consultancies:

  1. NONE

Speakers’ Bureaus:

  1. NONE

Other Activities:

  1. NONE

Clinical Procedures or Imaging Studies:

  1. NONE

Research Support, Commercial Entities:

  1. NONE

Research Support, Government Entities:

  1. National Institutes of Health grant U01At-001653. The National Center for Complementary and Alternative Medicine funded the trial (WISH).

Research Support, Academic Entities:

  1. NONE

Research Support, Foundations and Societies:

  1. NONE

Stock/Stock Options/Board of Directors Compensation:

  1. NONE

License Fee Payments, Technology or Inventions:

  1. NONE

Royalty Payments, Technology or Inventions:

  1. NONE

Stock/Stock Options, Research Sponsor:

  1. NONE

Stock/Stock Options, Medical Equipment & Materials:

  1. NONE

Legal Proceedings:

  1. NONE

Scientific Advisory Boards:

  1. NONE

Gifts:

  1. NONE

Funding for Travel or Speaker Honoraria:

  1. NONE

Editorial Boards:

  1. NONE

Patents:

  1. NONE

Publishing Royalties:

  1. NONE

Employment, Commercial Entity:

  1. NONE

Consultancies:

  1. NONE

Speakers’ Bureaus:

  1. NONE

Other Activities:

  1. NONE

Clinical Procedures or Imaging Studies:

  1. NONE

Research Support, Commercial Entities:

  1. Solae LLC (St Louis, MO) provided the study products gratis for the trial, WISH (manuscript under consideration).

Research Support, Government Entities:

  1. National Institutes of Health grant U01AT-001653 from the National Center for Complementary and Alternative Medicine funded the trial, WISH (manuscript under consideration).

Research Support, Academic Entities:

  1. NONE

Research Support, Foundations and Societies:

  1. NONE

Stock/Stock Options/Board of Directors Compensation:

  1. NONE

License Fee Payments, Technology or Inventions:

  1. NONE

Royalty Payments, Technology or Inventions:

  1. NONE

Stock/Stock Options, Research Sponsor:

  1. NONE

Stock/Stock Options, Medical Equipment & Materials:

  1. NONE

Legal Proceedings:

  1. NONE

Scientific Advisory Boards:

  1. NONE

Gifts:

  1. NONE

Funding for Travel or Speaker Honoraria:

  1. NONE

Editorial Boards:

  1. NONE

Patents:

  1. NONE

Publishing Royalties:

  1. NONE

Employment, Commercial Entity:

  1. NONE

Consultancies:

  1. NONE

Speakers’ Bureaus:

  1. NONE

Other Activities:

  1. NONE

Clinical Procedures or Imaging Studies:

  1. NONE

Research Support, Commercial Entities:

  1. NONE

Research Support, Government Entities:

  1. NIH/NCCAM, U01AT-001653, Project Manager; NIH/NIA, R01AG-024154, Data Analyst; NIH/NICHD, HD32632-10, Data Manager

Research Support, Academic Entities:

  1. NONE

Research Support, Foundations and Societies:

  1. NONE

Stock/Stock Options/Board of Directors Compensation:

  1. NONE

License Fee Payments, Technology or Inventions:

  1. NONE

Royalty Payments, Technology or Inventions:

  1. NONE

Stock/Stock Options, Research Sponsor:

  1. NONE

Stock/Stock Options, Medical Equipment & Materials:

  1. NONE

Legal Proceedings:

  1. NONE

Scientific Advisory Boards:

  1. NONE

Gifts:

  1. NONE

Funding for Travel or Speaker Honoraria:

  1. Morehouse School of Medicine: Hosts of NFL Player Care Neurological Care Program (12/6/11); payment made directly to airline and hotel

Editorial Boards:

  1. NONE

Patents:

  1. NONE

Publishing Royalties:

  1. NONE

Employment, Commercial Entity:

  1. NONE

Consultancies:

  1. NONE

Speakers’ Bureaus:

  1. NONE

Other Activities:

  1. NONE

Clinical Procedures or Imaging Studies:

  1. NONE

Research Support, Commercial Entities:

  1. NONE

Research Support, Government Entities:

  1. NIH 5P50AG005142-27 (4/1/10-3/3/15) Neuropsychologist 1992-present

Research Support, Academic Entities:

  1. NONE

Research Support, Foundations and Societies:

  1. NONE

Stock/Stock Options/Board of Directors Compensation:

  1. NONE

License Fee Payments, Technology or Inventions:

  1. NONE

Royalty Payments, Technology or Inventions:

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  1. NONE

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  1. NONE

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  1. NONE

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  1. NONE

Gifts:

  1. NONE

Funding for Travel or Speaker Honoraria:

  1. NONE

Editorial Boards:

  1. associate editor of Drug Testing and Analysis since 2009

Patents:

  1. NONE

Publishing Royalties:

  1. NONE

Employment, Commercial Entity:

  1. NONE

Consultancies:

  1. NONE

Speakers’ Bureaus:

  1. NONE

Other Activities:

  1. NONE

Clinical Procedures or Imaging Studies:

  1. NONE

Research Support, Commercial Entities:

  1. NONE

Research Support, Government Entities:

  1. NONE

Research Support, Academic Entities:

  1. NONE

Research Support, Foundations and Societies:

  1. NONE

Stock/Stock Options/Board of Directors Compensation:

  1. NONE

License Fee Payments, Technology or Inventions:

  1. NONE

Royalty Payments, Technology or Inventions:

  1. NONE

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  1. NONE

Stock/Stock Options, Medical Equipment & Materials:

  1. NONE

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Scientific Advisory Boards:

  1. NHLBI Clinical Trials Review Study Section

Gifts:

  1. NONE

Funding for Travel or Speaker Honoraria:

  1. NONE

Editorial Boards:

  1. NONE

Patents:

  1. NONE

Publishing Royalties:

  1. NONE

Employment, Commercial Entity:

  1. NONE

Consultancies:

  1. NONE

Speakers’ Bureaus:

  1. NONE

Other Activities:

  1. NONE

Clinical Procedures or Imaging Studies:

  1. NONE

Research Support, Commercial Entities:

  1. NONE

Research Support, Government Entities:

  1. NIA U01AT-001653 2004-2009; NIA P50 AG05142 2011-2016; NIAID R01AI-052065 2007-2012; NIA R01AG-033288 2010-2012; NCRR U54RR026075 2010-2015; NIA R01AG-024154 2010-2013; NICHD HD32632-10 2007-2012; NIA PO1 AG12435 2008-2013; NIA P01 AG026572 2011-2016

Research Support, Academic Entities:

  1. NONE

Research Support, Foundations and Societies:

  1. NONE

Stock/Stock Options/Board of Directors Compensation:

  1. NONE

License Fee Payments, Technology or Inventions:

  1. NONE

Royalty Payments, Technology or Inventions:

  1. NONE

Stock/Stock Options, Research Sponsor:

  1. NONE

Stock/Stock Options, Medical Equipment & Materials:

  1. NONE

Legal Proceedings:

  1. NONE

Abstract

Objective: To determine the cognitive effects of long-term dietary soy isoflavones in a daily dose comparable to that of traditional Asian diets.

Methods: In the double-blind Women's Isoflavone Soy Health trial, healthy postmenopausal women were randomly allocated to receive daily 25 g of isoflavone-rich soy protein (91 mg of aglycone weight of isoflavones: 52 mg of genistein, 36 mg of daidzein, and 3 mg glycitein) or milk protein−matched placebo. The primary cognitive endpoint compared between groups at 2.5 years was change from baseline on global cognition, a composite of the weighted sum of 14 neuropsychological test score changes. Secondary outcomes compared changes in cognitive factors and individual tests.

Results: A total of 350 healthy postmenopausal women aged 45–92 years enrolled in this trial; 313 women with baseline and endpoint cognitive test data were included in intention-to-treat analyses. Adherence in both groups was nearly 90%. There was no significant between-group difference on change from baseline in global cognition (mean standardized improvement of 0.42 in the isoflavone group and 0.31 in the placebo group; mean standardized difference 0.11, 95% confidence interval [CI] −0.13 to 0.35). Secondary analyses indicated greater improvement on a visual memory factor in the isoflavone group (mean standardized difference 0.33, 95% CI 0.06–0.60) but no significant between-group differences on 3 other cognitive factors or individual test scores, and no significant difference within a subgroup of younger postmenopausal women.

Conclusion: For healthy postmenopausal women, long-term dietary soy isoflavone supplementation in a dose comparable to that of traditional Asian diets has no effect on global cognition but may improve visual memory.

Classification of evidence: This study provides Class I evidence that long-term dietary supplementation with isoflavone-rich soy protein does not improve global cognition of healthy postmenopausal women.

GLOSSARY

CI=
confidence interval;
ISP=
isoflavone-rich soy protein;
WISH=
Women's Isoflavone Soy Health

Footnotes

  • Study funding: Supported by the National Center of Complementary and Alternative Medicine, the Office of Dietary Supplements, and the Office of Research on Women's Health (NIH grant U01-AT001653). Solae LLC (St. Louis, MO) provided study products without charge.

  • WISH Research Group Coinvestigators are listed on the Neurology® Web site at www.neurology.org.

  • Supplemental data at www.neurology.org

  • Received November 8, 2011.
  • Accepted January 31, 2012.
  1. doi: 10.1212/WNL.0b013e318258f822 Neurology vol. 78 no. 23 1841-1848
  1. » Abstract
  2. Figures Only
  3. Full Text
  4. Full Text (PDF)
  5. Data Supplement
  6. Coinvestigators
  7. PPT Slides of All Figures

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