Bioavailability of Isoflavones Delivered by Soy Almond Bread in Men With Recurring Prostate Cancer and Rising Prostate Specific Antigen
I. To precisely quantify the absorption, serum concentrations over time, and excretion
patterns of soy isoflavones and metabolites in men consuming the two bread products to
define relationships between dietary intake, isoflavone metabolism and the biological
II. To describe the safety as well as incidence and severity of toxicity in men consuming
the control soy bread or beta-glucosidase-enriched soy bread.
III. To see if consumption of beta-glucosidase-enriched soy bread compared to control soy
bread has a greater effect on blood hormonal patterns and biomarkers that favor
anti-prostate cancer activity.
IV. To see if beta-glucosidase-enriched soy bread compared to control soy bread improves
hormonal patterns (lower insulin like growth factor-I, increased insulin like growth factor
binding protein 3, lower androgens), reduce prostate specific antigen velocity, and lower
circulating vascular endothelial growth factor concentrations.
OUTLINE: Patients are randomized to 1 of 2 treatment arms (closed to accrual as of
ARM I: Patients consume 2 slices of soy bread daily for 8 weeks.
ARM II: Patients consume 2 slices of soy almond bread daily for 8 weeks.
After a 2 week washout period, patients crossover to the alternate treatment arm.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Peak plasma concentrations (Cmax) of soy isoflavones and their metabolites
Quantification of absorption, serum concentrations over time, and excretion patterns of soy isoflavones and metabolites to define relationships between dietary intake, isoflavone metabolism and the biological outcomes
0, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post dose
Ohio State University
United States: Institutional Review Board
|The Ohio State University Medical Center||Columbus, Ohio 43210|