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

Phase 3

Completed

• Conditions: Healthy Men
• Interventions: Dietary Supplement: lycopene

• Registration Number: NCT01221558
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Status Verified: 2009-06
• Study Start: 2009-07
• Primary Completion: 2010-04
• Study Completion: 2010-09
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-14
• Last Update Submitted: 2010-10-14
• Study First Posted: 2010-10-15
• Last Update Posted: 2010-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6mg lycopene	lycopene	-
15mg lycopene	lycopene	-
placebo	lycopene	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.; 🇰🇷 Seoul, Korea, Republic of