Lycopene in Preventing Prostate Cancer in Healthy Participants
NCT ID: NCT00322114
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2006-02-28
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PREVENTION
Study Groups
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Arm I
Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.
lycopene
Given orally
Arm II
Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.
lycopene
Given orally
Arm III
Participants receive oral placebo twice daily for 3 weeks.
placebo
Given orally
Interventions
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lycopene
Given orally
placebo
Given orally
Eligibility Criteria
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Inclusion Criteria
* Healthy participants
* No existing prostate disease
PATIENT CHARACTERISTICS:
* Able to supply blood and urine samples
* Able to answer demographic and dietary recall questionnaires
* No hospital inpatients
* Not allergic to tomatoes or tomato products
* Not abusing alcohol or non-prescribed drugs
* No existing gastrointestinal disease or cancer
PRIOR CONCURRENT THERAPY:
* At least 2 weeks since prior lycopene (in supplement form)
* No concurrent participation in another clinical trial
18 Years
MALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Illinois at Chicago
OTHER
Principal Investigators
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Richard B. van Breemen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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University of Illinois Cancer Center
Chicago, Illinois, United States
Countries
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Facility Contacts
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Clinical Trial Office - University of Illinois Cancer Center
Role: primary
Other Identifiers
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UIC-2004-0217
Identifier Type: -
Identifier Source: secondary_id
CDR0000468031
Identifier Type: -
Identifier Source: org_study_id