The Specific Role of Isoflavones in Reducing Prostate Cancer Risk
To prevent biasing the outcome of the study, this is a double-blind study design, where both
the trialists and the participants are blinded to the specific nature of the product
(isoflavones and placebo). Participants in both groups will be discouraged from increasing
their intake of dietary isoflavones in the form of tofu, soy beans, soy milk, etc. In
addition, the intervention does not include active counseling on dietary modification and
supplementation of any one group. Monthly appointments will be made for all participants
for data collection and toxicity assessment.
This is a controlled, randomized, double blinded clinical trial, having one experimental and
one control group (n - 75/arm). Participants in the experimental group will consume an
isoflavones supplement in the form of Prevastein HC®, which will deliver 80 mgs (40 mg/dose)
biologically active isoflavones and those in the control group will receive an
identical placebo. The isoflavones supplement and the placebo tablets will be manufactured
and packaged by Cognis Corporation.
1. Isoflavones will be supplied at no charge by Cognis Corporation, LaGrange, Illinois as
Prevastein HC®. Each Prevastein HC® tablet delivers 20 mg biologically active
isoflavones, which is available for absorption. Participants will consume 2 tablets
twice daily (with meals) in addition to their usual diet.
2. Placebo will be supplied at no charge by Cognis Corporation, LaGrange, Illinois as an
indistinguishable tablet. Participants will consume 2 tablets twice daily (with meals)
in addition to their usual diet.
3. A standardized multivitamin will be supplied at no charge.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Observe the effects of the 12 - week intervention with isoflavones on sex hormones and PSA, a marker of disease progression.
12 week treatments
Nagi B. Kumar, PhD., RD
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
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