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Cited by 62Phytoestrogen effects and researchEstrogen and related hormone effectsCarcinogens and Genotoxicity Assessment

Effects of a high daily dose of soy isoflavones on DNA damage, apoptosis, and estrogenic outcomes in healthy postmenopausal women: A phase I clinical trial

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Pop, Elena A., Fischer, Leslie M., Coan, April D., Gitzinger, Matt, Nakamura, Jun, Zeisel, Steven H.·2008·Menopause
DOI 10.1097/gme.0b013e318167b8f2PMC PMC2574732
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Abstract

OBJECTIVE: A phase I double-blind clinical trial was conducted to evaluate the effects of a high oral dose of soy isoflavones administered daily for 84 days to healthy postmenopausal women. Principal outcome measures included DNA damage, apoptosis, and changes indicative of estrogenic stimulation. DESIGN: After eligibility and equol-producer status were determined, stratified randomization was used to assign women to the isoflavone (active) or placebo group. Of the 30 women who completed the study, 18 were in the active group. DNA damage was assessed via COMET and apurinic/apyrimidinic site assays in lymphocytes. Apoptosis was evaluated via terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling and activated caspase-3 assays in lymphocytes. Estrogenic/antiestrogenic effects were assessed using a self-report questionnaire and by assaying for estrogen, follicle-stimulating hormone, luteinizing hormone, and sex hormone-binding globulin in blood. RESULTS: In treated postmenopausal women, there was no indication that high doses of soy isoflavones caused DNA strand breakage, increased apurinic/apyrimidinic sites, or increased apoptosis in peripheral lymphocytes. There were no significant changes in mean values for estrogenic effects or other laboratory measurements. Very few adverse events occurred, and the only drug-related adverse events were mild or grade 1 in severity. CONCLUSIONS: Unconjugated soy isoflavones appear to be safe and well tolerated in healthy postmenopausal women at doses of 900 mg/day.

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  • A total of 18 RCTs assessed circulating estrogen levels; 15 of 18 found no significant impact from soy compared to control.

    “A total of 18 RCTs assessed circulating estrogens levels (E1, E2, and/ or E3) Fifteen of 18 studies found no significant impact from soy compared to the control group (p>0.05) [129,132,133,138,140,143,145,147,149,150,155,156,158,160,163].”

    From Soy, Red Clover, and Isoflavones and Breast Cancer: A Systematic Review (2013) · cites this paper as [138]

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Authors
Pop, E. A., Fischer, L. M., Coan, A. D., Gitzinger, M., Nakamura, J., & Zeisel, S. H.
Affiliations
University of North Carolina at Chapel Hill (US)
Corresponding author
Zeisel, Steven H.
ORCID
Venue
Menopause
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2008-07
Volume
15
Issue
4
Pages
684-692
ISSN
1072-3714 (ISSN-L)
DOI
10.1097/gme.0b013e318167b8f2
PMC
PMC2574732
OpenAlex
W1986182988
Cited by
62
References
2
Citations by year
2026: 1 · 2025: 2 · 2024: 5 · 2023: 7 · 2022: 7 · 2021: 7 · 2020: 2 · 2019: 4 · 2018: 4 · 2017: 4 · 2016: 2 · 2015: 4 · 2014: 1 · 2013: 2 · 2012: 2
FWCI
1.81
Type
journal article
Language
en
Open access
Locations
  • Menopause The Journal of The North American Menopause Society (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
  • UNC Libraries
Funders
  • Mead Johnson Nutrition
  • National Institutes of Health (n01cn075035-003, RR-00046, DK56350, ES10126)
  • National Cancer Institute (NCI‐N01‐CN‐75035)
  • National Institute of Diabetes and Digestive and Kidney Diseases (DK56350, P30DK056350)
  • National Institute of Environmental Health Sciences (ES 10126, P30ES010126)
  • National Center for Research Resources (RR00046, M01RR000046)
Topics
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Phytoestrogen effects and research
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Estrogen and related hormone effects
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Carcinogens and Genotoxicity Assessment
Keywords
soy isoflavones, postmenopausal women, DNA damage, apoptosis, lymphocytes, estrogenic effects, equol, safety and tolerability, sex hormones, follicle-stimulating hormone, luteinizing hormone, sex hormone-binding globulin, caspase-3
MeSH terms
Administration, Oral, Capsules, DNA Damage, Double-Blind Method, Estrogens, Female, Humans, Isoflavones, Lymphocytes, Middle Aged, Glycine max, Apoptosis, Postmenopause, Dietary Supplements, Genistein, Equol

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