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

January 8, 2008 updated by: National Taiwan University Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male subjects aged 40 or older with no pathologically-proven prostate cancer or other cancers. Patients who have had a negative prostate biopsy are still acceptable.
  • Subjects with a PSA between 2.5 and 20.0 ng/ml.
  • Subjects understand the study procedures and agree to participate in the study by providing a written informed consent and scheduled blood or urine samples.
  • Subjects whose liver function and renal function tests are within normal range.

Exclusion Criteria:

  • Subjects who may have fluctuated serum PSAs, such as urinary tract infection, prostatitis, acute urinary retention, receiving radiotherapy to the pelvis, etc.
  • Subjects who have received a prostate surgery or biopsy within 6 weeks before the initiation of lycopene supplementation.
  • Subjects who may or will receive a prostate surgery or biopsy within 12 weeks of the initiation of lycopene supplementation.
  • Subjects who have known allergic reaction to carotenoids including lycopene.
  • Subjects who are participating or will participate in other clinical trials.
  • Subjects who are taking medications that may alter serum PSA levels, such as 5-alpha reductase inhibitor (eg. finasteride), sex steroids or hormonal agents (eg. luteinizing hormone releasing hormone agonists, cyproterone acetate, flutamide, bicalutamide, megesterol acetate, etc.).
  • Subjects who may require increased dosage of medications for lower urinary tract symptoms (LUTS) during the 12 weeks of protocol treatment. Subjects who have been put on medications for LUTS before entry and have a stabilized disease are still acceptable. These medications include, but note limited to, selective or non-selective alpha-blockers and anti-cholinergics.
  • Subjects who have or have had clinical gastrointestinal malabsorption regardless of the etiology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Lycopene 15 mg/day
Drug: Lycopene
A: Lycopene15 mg/day ; B: Lycopene30 mg/day
EXPERIMENTAL: B
Lycopene 30 mg/day
Drug: Lycopene
A: Lycopene15 mg/day ; B: Lycopene30 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum lycopene levels
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
I-PSS, peak flow rate
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (ACTUAL)

June 1, 2005

Study Completion (ACTUAL)

June 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (ESTIMATE)

September 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2008

Last Update Submitted That Met QC Criteria

January 8, 2008

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 920704

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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