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

October 14, 2010 updated by: Yonsei University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-749
        • Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Dietary supplement: lycopene
Experimental: 6mg lycopene
Dietary supplement: lycopene
Experimental: 15mg lycopene
Dietary supplement: lycopene

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Jong Ho Lee, Ph.D., Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 13, 2010

First Submitted That Met QC Criteria

October 14, 2010

First Posted (Estimate)

October 15, 2010

Study Record Updates

Last Update Posted (Estimate)

October 15, 2010

Last Update Submitted That Met QC Criteria

October 14, 2010

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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