Mechanism of Prostate Cancer Prevention by Lycopene
OBJECTIVES:
Primary
- Determine whether lycopene supplementation affects percent free and bound
prostate-specific antigen (PSA) in healthy participants.
Secondary
- Determine whether lycopene reduces oxidative stress in these participants, as indicated
by lipid peroxidation assay.
- Determine whether a 21-day washout period is sufficient to return lycopene, PSA, and
lipid peroxidation products to baseline.
OUTLINE: This is a randomized, placebo-controlled study. Participants are randomized to 1 of
3 treatment arms.
- Arm I: Participants receive an oral tomato dietary supplement containing lycopene twice
daily for 3 weeks.
- Arm II: Participants receive an oral tomato dietary supplement containing lycopene at a
higher dose twice daily for 3 weeks.
- Arm III: Participants receive oral placebo twice daily for 3 weeks. Urine and blood
samples are collected on days 0, 21, and 42.
PROJECTED ACCRUAL: A total of 150 participants will be accrued for this study.
Interventional
Allocation: Randomized, Primary Purpose: Prevention
Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene
No
Richard B. van Breemen, PhD
Principal Investigator
University of Illinois
Unspecified
CDR0000468031
NCT00322114
February 2006
Name | Location |
---|---|
University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |