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

NCT ID: NCT01221558

Last Updated: 2010-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-09-30

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.

Conditions

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Healthy Men

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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6mg lycopene

Group Type EXPERIMENTAL

lycopene

Intervention Type DIETARY_SUPPLEMENT

15mg lycopene

Group Type EXPERIMENTAL

lycopene

Intervention Type DIETARY_SUPPLEMENT

placebo

Group Type PLACEBO_COMPARATOR

lycopene

Intervention Type DIETARY_SUPPLEMENT

Interventions

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lycopene

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Yonsei University

Principal Investigators

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Jong Ho Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

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Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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L-01

Identifier Type: -

Identifier Source: org_study_id