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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01221558
First received: October 13, 2010
Last updated: October 14, 2010
Last verified: June 2009
  Purpose

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 Intervention Phase
Healthy Men
Dietary Supplement: lycopene
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Lycopene Supplementation on Oxidative Stress and Markers of Endothelial Function in Healthy Men

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • lymphocyte DNA damage [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • antioxidant enzymes : SOD, GSH-Px, Catalase [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • lipid peroxidation marker : MDA, urinary 8 epi-PGF 2alpha [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • oxidized LDL [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reactive hyperemia peripheral arterial tonometry (RH-PAT) index [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • VCAM-1/ICAM-1 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • cytokines : IL-6, TNF-alpha, IL-1beta [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • hs-CRP [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 126
Study Start Date: July 2009
Study Completion Date: September 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 6mg lycopene Dietary Supplement: lycopene
Experimental: 15mg lycopene Dietary Supplement: lycopene
Placebo Comparator: placebo Dietary Supplement: lycopene

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: principal investigator : Jong Ho Lee, Ph.D., Yonsei University
ClinicalTrials.gov Identifier: NCT01221558     History of Changes
Other Study ID Numbers: L-01
Study First Received: October 13, 2010
Last Updated: October 14, 2010
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014