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Prostate Cancer Prevention Trial With Quercetin and Genistein

NCT01538316 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-05-15

No results posted yet for this study

Summary

The aim of the randomized controlled double-blind crossover trial is to evaluate the effectiveness of two dietary supplements containing polyphenolic phytochemicals (isoflavonoid genistein and flavonoid quercetin) in comparison with placebo on the rate of increase in prostate-specific antigen (PSA). In addition, secondary objective is to evaluate the incidence of prostate cancer and to analyze malondialdehyde and protein carbonyle as indicators of the oxidative status.

Conditions

  • Primary Prevention of Prostate Cancer

Interventions

DIETARY_SUPPLEMENT

Quercetin supplement

500 mg/d quercetin (+ vitamin C + folic acid + vitamin B3) over a period of six months; crossover design (6 month-periods): followed by genistein and placebo supplement.

DIETARY_SUPPLEMENT

Genistein supplement

100 mg/d genistein (+ vitamin C + folic acid + vitamin B3) over a period of six months; crossover design (6 month-periods): followed by placebo and quercetin supplement.

DIETARY_SUPPLEMENT

Placebo

vitamin C + folic acid + vitamin B3 over a period of six months; crossover design (6 month-periods): followed by quercetin and genistein supplement.

Sponsors & Collaborators

  • University Hospital Tuebingen

    collaborator OTHER

  • Quercegen Pharmaceuticals

    collaborator INDUSTRY

  • University of Hohenheim

    lead OTHER

Principal Investigators

  • Stephan C Bischoff, MD, Prof. · University of Hohenheim

  • Arnulf Stenzl, MD, Prof. · Dept. of Urology, University Hospital Tübingen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-03-31
Completion
2014-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01538316 on ClinicalTrials.gov