Clinical trial NCT01221558: Effects of Lycopene on Oxidative Stress and Markers of Endothelial Function Healthy Men
Official title: Effects of Lycopene Supplementation on Oxidative Stress and Markers of Endothelial Function in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Men
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-10-15
Enrollment: 126
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: lymphocyte DNA damage
timeFrame: 8 weeks
measure: antioxidant enzymes : SOD, GSH-Px, Catalase
timeFrame: 8 weeks
measure: lipid peroxidation marker : MDA, urinary 8 epi-PGF 2alpha
timeFrame: 8 weeks
measure: oxidized LDL
timeFrame: 8 weeks
Secondary outcomes:
measure: Reactive hyperemia peripheral arterial tonometry (RH-PAT) index
timeFrame: 8 weeks
measure: VCAM-1/ICAM-1
timeFrame: 8 weeks
measure: cytokines : IL-6, TNF-alpha, IL-1beta
timeFrame: 8 weeks
measure: hs-CRP
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Study officials:
affiliation: Yonsei University
name: Jong Ho Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: