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OpenTrials
Completed

NCT Number: NCT01221558

Effects of Lycopene on Oxidative Stress and Markers of Endothelial Function 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.

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Key information

Conditions

Healthy Men

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, 120-749, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lycopene

Dietary Supplement

Primary outcomes

  1. lymphocyte DNA damage

    Time frame: 8 weeks

  2. antioxidant enzymes : SOD, GSH-Px, Catalase

    Time frame: 8 weeks

  3. lipid peroxidation marker : MDA, urinary 8 epi-PGF 2alpha

    Time frame: 8 weeks

  4. oxidized LDL

    Time frame: 8 weeks

Secondary outcomes

  1. Reactive hyperemia peripheral arterial tonometry (RH-PAT) index

    Time frame: 8 weeks

  2. VCAM-1/ICAM-1

    Time frame: 8 weeks

  3. cytokines : IL-6, TNF-alpha, IL-1beta

    Time frame: 8 weeks

  4. hs-CRP

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 15, 2010
Registry last updated
Oct 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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