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A Clinical Study to Determine Factors Affecting Absorption and Serum Levels of Lycopene After Supplementation

BPH Clinical Trial

Official title:
A Clinical Study to Determine Factors Affecting Absorption and Serum Levels of Lycopene After Supplementation

Clinical Trial Summary

Primary: To determine factors that affect absorption and serum levels of lycopene after supplementation.

Secondary:

1. To evaluate general safety and tolerability of oral lycopene 15 or 30 mg per day for 12 weeks.

2. To determine lycopene effects on reducing serum levels of prostate specific antigen (PSA) and on relieving lower urinary tract symptoms (LUTS) in relation to prostate hypertrophy as evaluated by the International Prostate Symptom Score (I-PSS).

Clinical Trial Description

This is an uncontrolled intervention study in which eligible male subjects (N=60), after a two-week washout, will be randomized to receive lycopene either 15 or 30 mg per day for 12 weeks. About equal numbers of subjects will be randomized to either 15 or 30 mg of lycopene (about 30 subjects for each arm). The study is expected to be finished in 2 year. The study is expected to be finished in 2 year. Concerning an expected dropout rate of 10%, 66 subjects will be recruited for the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00154843
Study type Interventional
Source National Taiwan University Hospital
Contact
Status Completed
Phase Phase 2
Start date March 2004
Completion date June 2005
View Details
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