NCT00154843

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• BPH

Interventions

Type	Name	Description
DRUG	Lycopene	A: Lycopene15 mg/day ; B: Lycopene30 mg/day

Timeline

• Start date: 2004-03-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2005-09-12
• Last updated: 2008-01-14

Locations

1 site across 1 country: Taiwan