Phase I Multiple-Dose Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women
This will be a double blind, Phase I, multiple dose clinical trial of orally administered
soy isoflavones (PTI G-2535, 70% unconjugated isoflavones containing genistein, daidzein,
and glycitein). This preparation will be referred to as soy isoflavones in this and all
study related documents to more accurately reflect the study drug’s content. The multiple
dose trial will last four months (112 days) and will include healthy, post-menopausal women
as determined by FSH levels and lack of spontaneous bleeding for at least one year. After
eligibility is determined, all potential subjects will ingest a soy shake to determine if
they are producers of the daidzein metabolite, equol. We expect to find approximately 30% of
our eligible subjects to be equol-producers as published in the literature. Equol producers
will be defined as individuals with plasma levels >20ug/L; non-equol producers as those with
<10ug/L 37. Individuals with intermediate equol values (> 10 ug/L to < 20 ug/L) will be
excluded from the study. Stratified randomization will assign the subjects to one of the two
groups, aiming for 30-40% equol producers in each group. Group 1 (20 subjects) will receive
a dietary supplement containing 600 mg of genistein in two doses of 300 mg (as part of a
soy isoflavones mixture) per day orally administered over an 84-day period. Group 2 (10
subjects) will receive a placebo supplement (excipients from the active formulation), orally
administered over an 84-day period. These women will be recruited from the local population
within the Research Triangle area. The study will be conducted at the UNC Hospital General
Clinical Research Center (GCRC).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind
DNA damage, apoptosis, estrogenic effects and changes in gene expression
112 days
Steven H Zeisel, MD, PhD
Principal Investigator
UNC at Chapel Hill
United States: Food and Drug Administration
NCI-N01-CN-75035
NCT00491595
March 2004
July 2005
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