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

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ClinicalTrials.gov Identifier: NCT01221558
Recruitment Status : Completed
First Posted : October 15, 2010
Last Update Posted : October 15, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Men Dietary Supplement: lycopene Phase 3

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  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Lycopene Supplementation on Oxidative Stress and Markers of Endothelial Function in Healthy Men
Study Start Date : July 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene

Arm Intervention/treatment
Experimental: 6mg lycopene Dietary Supplement: lycopene
Experimental: 15mg lycopene Dietary Supplement: lycopene
Placebo Comparator: placebo Dietary Supplement: lycopene



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221558


Locations
Korea, Republic of
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, Korea, Republic of, 120-749
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Jong Ho Lee, Ph.D. Yonsei University

Responsible Party: principal investigator : Jong Ho Lee, Ph.D., Yonsei University
ClinicalTrials.gov Identifier: NCT01221558     History of Changes
Other Study ID Numbers: L-01
First Posted: October 15, 2010    Key Record Dates
Last Update Posted: October 15, 2010
Last Verified: June 2009

Additional relevant MeSH terms:
Lycopene
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents