Healthy MenPhase 3NCT01221558
Effects of Lycopene on Oxidative Stress and Markers of Endothelial Function Healthy Men
A Phase 3 study testing lycopene in people with Healthy Men, run by Yonsei University at 1 site in South Korea.
Trial summary
The hypothesis was that an increase in serum lycopene levels following supplementation with capsules containing natural lycopene rich tomato extract would reduce oxidative stress and improve endothelial function in healthy men with low intake of fruits and vegetables. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men
- What is being tested?
- lycopene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2009to Sep 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men who frequently smoked cigarettes or consumed alcohol
Who cannot join
- consumption of more than 3 servings/day of vegetables and fruit, or more than one serving/week of lycopene-rich foods
- taking antioxidant, vitamin, or mineral supplements
- any history of chronic disease (diabetes, heart disease, renal disease)
- taking lipid-lowering or antihypertensive medications
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, 120-749
About this study
Official title: Effects of Lycopene Supplementation on Oxidative Stress and Markers of Endothelial Function in Healthy Men
The hypothesis was that an increase in serum lycopene levels following supplementation with capsules containing natural lycopene rich tomato extract would reduce oxidative stress and improve endothelial function in healthy men with low intake of fruits and vegetables. A randomized double-blind, placebo-controlled study was designed to assess the changes in serum lycopene levels, oxidative stress and endothelial function in response to an 8-week treatment with lycopene supplementation.
Read the detailed description
The healthy men aged 20-60 years, who frequently smoked cigarettes or consumed alcohol, were enrolled in this study. Subjects were excluded if they consumed more than 3 servings/day of vegetables and fruit, or more than one serving/week of lycopene-rich foods; took antioxidant, vitamin, or mineral supplements; had any history of chronic disease; or were taking lipid-lowering or antihypertensive medications.The subjects were randomly assigned to receive placebo, 6mg, or 15mg lycopene capsule per day for 8 weeks. Study substances were suspended in soybean oil and given in acid-soluble gelatin capsules. A placebo containing soybean oil (100%) was supplied in identical-looking capsules. All the subjects were instructed to consume one capsule per day right after any meal of their choice. All participants were encouraged to maintain their usual lifestyle and dietary habits.
- Conditions
- Healthy Men
- Being tested
- lycopene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lycopeneDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 6mg lycopene | Experimental | Not described Receives: Dietary Supplement: lycopene |
| 15mg lycopene | Experimental | Not described Receives: Dietary Supplement: lycopene |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: lycopene |
What is being measured
The primary outcome is the main question the study is designed to answer.
lymphocyte DNA damage
Measured: 8 weeks
antioxidant enzymes : SOD, GSH-Px, Catalase
Measured: 8 weeks
lipid peroxidation marker : MDA, urinary 8 epi-PGF 2alpha
Measured: 8 weeks
oxidized LDL
Measured: 8 weeks
Secondary outcomes (4)
Reactive hyperemia peripheral arterial tonometry (RH-PAT) index
Measured: 8 weeks
VCAM-1/ICAM-1
Measured: 8 weeks
cytokines : IL-6, TNF-alpha, IL-1beta
Measured: 8 weeks
hs-CRP
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startJul 2009
- Primary completionApr 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MenStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Jong Ho Lee, Ph.D., Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221558
- Sponsor's protocol ID
- L-01
- Status last verified
- Jun 2009
- First submitted
- 13 Oct 2010
- Last updated
- 15 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lycopene Supplementation on Oxidative Stress and Markers of Endothelial Function in Healthy Men
- ClinicalTrials.gov ID
- NCT01221558
- Acronym / sponsor ID
- L-01
- Conditions
- Healthy Men
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis was that an increase in serum lycopene levels following supplementation with capsules containing natural lycopene rich tomato extract would reduce oxidative stress and improve endothelial function in healthy men with low intake of fruits and vegetables. A randomized double-blind, placebo-controlled study was designed to assess the changes in serum lycopene levels, oxidative stress and endothelial function in response to an 8-week treatment with lycopene supplementation.
Detailed description
The healthy men aged 20-60 years, who frequently smoked cigarettes or consumed alcohol, were enrolled in this study. Subjects were excluded if they consumed more than 3 servings/day of vegetables and fruit, or more than one serving/week of lycopene-rich foods; took antioxidant, vitamin, or mineral supplements; had any history of chronic disease; or were taking lipid-lowering or antihypertensive medications.The subjects were randomly assigned to receive placebo, 6mg, or 15mg lycopene capsule per day for 8 weeks. Study substances were suspended in soybean oil and given in acid-soluble gelatin capsules. A placebo containing soybean oil (100%) was supplied in identical-looking capsules. All the subjects were instructed to consume one capsule per day right after any meal of their choice. All participants were encouraged to maintain their usual lifestyle and dietary habits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6mg lycopene | Experimental | Dietary Supplement: lycopene |
| 15mg lycopene | Experimental | Dietary Supplement: lycopene |
| placebo | Placebo comparator | Dietary Supplement: lycopene |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy men who frequently smoked cigarettes or consumed alcohol
Key exclusion criteria (4 listed)
- consumption of more than 3 servings/day of vegetables and fruit, or more than one serving/week of lycopene-rich foods
- taking antioxidant, vitamin, or mineral supplements
- any history of chronic disease (diabetes, heart disease, renal disease)
- taking lipid-lowering or antihypertensive medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lycopene | Dietary supplement | 15mg lycopene, 6mg lycopene, placebo |
Primary outcome
lymphocyte DNA damage
Time frame: 8 weeks
antioxidant enzymes : SOD, GSH-Px, Catalase
Time frame: 8 weeks
lipid peroxidation marker : MDA, urinary 8 epi-PGF 2alpha
Time frame: 8 weeks
oxidized LDL
Time frame: 8 weeks
4 secondary outcomes
Reactive hyperemia peripheral arterial tonometry (RH-PAT) index
Time frame: 8 weeks
VCAM-1/ICAM-1
Time frame: 8 weeks
cytokines : IL-6, TNF-alpha, IL-1beta
Time frame: 8 weeks
hs-CRP
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Ho Lee, Ph.D. principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lycopene in people with Healthy Men, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lymphocyte DNA damage (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2010; AzTrials last refreshed its copy on 8 Nov 2026.