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Effects of Lycopene on Oxidative Stress and Markers of Endothelial Function Healthy Men

Effects of Lycopene Supplementation on Oxidative Stress and Markers of Endothelial Function in Healthy Men

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01221558
Enrollment
126
Registered
2010-10-15
Start date
2009-07-31
Completion date
2010-09-30
Last updated
2010-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Men

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTlycopene

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
20 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy men who frequently smoked cigarettes or consumed alcohol

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
lymphocyte DNA damage8 weeks
antioxidant enzymes : SOD, GSH-Px, Catalase8 weeks
lipid peroxidation marker : MDA, urinary 8 epi-PGF 2alpha8 weeks
oxidized LDL8 weeks

Secondary

MeasureTime frame
Reactive hyperemia peripheral arterial tonometry (RH-PAT) index8 weeks
VCAM-1/ICAM-18 weeks
cytokines : IL-6, TNF-alpha, IL-1beta8 weeks
hs-CRP8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026