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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Men

Intervention / Treatment
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* Dietary Supplement: lycopene


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6mg lycopene<br> | Dietary Supplement: lycopene<br> <br> |
| Experimental: 15mg lycopene<br> | Dietary Supplement: lycopene<br> <br> |
| Placebo Comparator: placebo<br> | Dietary Supplement: lycopene<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lymphocyte DNA damage |  | 8 weeks | 
| antioxidant enzymes : SOD, GSH-Px, Catalase |  | 8 weeks | 
| lipid peroxidation marker : MDA, urinary 8 epi-PGF 2alpha |  | 8 weeks | 
| oxidized LDL |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactive hyperemia peripheral arterial tonometry (RH-PAT) index |  | 8 weeks | 
| VCAM-1/ICAM-1 |  | 8 weeks | 
| cytokines : IL-6, TNF-alpha, IL-1beta |  | 8 weeks | 
| hs-CRP |  | 8 weeks |