Premium
Effects of a high daily dose of soy isoflavones on DNA damage, apoptosis and estrogenic outcomes in healthy, post‐menopausal women ‐ a Phase I clinical trial
Author(s) -
Pop Elena A.,
Fischer Leslie M.,
Zeisel Steven H.
Publication year - 2007
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.21.5.a370-c
Subject(s) - medicine , adverse effect , soy isoflavones , apoptosis , comet assay , dna damage , placebo , isoflavones , clinical trial , genistein , endocrinology , cancer , physiology , pharmacology , oncology , biology , pathology , dna , biochemistry , genetics , alternative medicine
OBJECTIVE: A Phase I double blind clinical trial was conducted to evaluate the effects of a high daily dose of soy isoflavones given for 84 days, in healthy, post‐menopausal women on DNA damage, apoptosis and estrogenic markers. DESIGN: After eligibility and equol‐producer status were determined, stratified randomization was used to assign subjects to the active or placebo group. From 30 subjects who successfully completed the study 18 were in the active group. The potential to induce DNA damage was assessed via COMET assay in peripheral lymphocytes and validated by AP site assay. Changes in apoptosis were evaluated via TUNEL and Caspase‐3 assays conducted on lymphocytes and endometrial tissue and estrogenic effects were measured. RESULTS: In treated post‐menopausal women there was no indication that high doses of soy isoflavones caused DNA strand breakage in peripheral lymphocytes or apoptosis in either peripheral lymphocytes or endometrial tissue samples. There were no clinically significant changes in mean estrogenic laboratory values or other laboratory measurements. Very few adverse events occurred and the only drug‐related adverse events were mild or grade 1 in severity. These results show that high daily doses of unconjugated soy isoflavones are safe and well tolerated in healthy‐postmenopausal women. This work was funded by a grant from National Cancer Institute (NCI‐N01‐CN‐75035).