The Specific Role of Isoflavones in Reducing Prostate Cancer Risk
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|ClinicalTrials.gov Identifier: NCT00617617|
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : September 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: Prevastein HC® Other: Placebo||Phase 2|
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.
- 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.
- 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.
- A standardized multivitamin will be supplied at no charge.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Specific Role of Isoflavones in Reducing Prostate Cancer Risk|
|Study Start Date :||February 2002|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
Dietary Supplement: Prevastein HC®
Dietary Supplement: Prevastein HC®
Experimental Group - 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.
Placebo Comparator: B
Control Group - Control Group participants will receive an identical placebo.
- Observe the effects of the 12 - week intervention with isoflavones on sex hormones and PSA, a marker of disease progression. [ Time Frame: 12 week treatments ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617617
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Nagi B. Kumar, PhD., RD||H. Lee Moffitt Cancer Center and Research Institute|