Effects of Lycopene on Oxidative Stress and Markers of Endothelial Function Healthy Men
Effects of Lycopene Supplementation on Oxidative Stress and Markers of Endothelial Function in Healthy Men
1 other identifier
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 13, 2010
CompletedFirst Posted
Study publicly available on registry
October 15, 2010
CompletedOctober 15, 2010
June 1, 2009
9 months
October 13, 2010
October 14, 2010
Conditions
Outcome Measures
Primary Outcomes (4)
lymphocyte DNA damage
8 weeks
antioxidant enzymes : SOD, GSH-Px, Catalase
8 weeks
lipid peroxidation marker : MDA, urinary 8 epi-PGF 2alpha
8 weeks
oxidized LDL
8 weeks
Secondary Outcomes (4)
Reactive hyperemia peripheral arterial tonometry (RH-PAT) index
8 weeks
VCAM-1/ICAM-1
8 weeks
cytokines : IL-6, TNF-alpha, IL-1beta
8 weeks
hs-CRP
8 weeks
Study Arms (3)
6mg lycopene
EXPERIMENTAL15mg lycopene
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- healthy men who frequently smoked cigarettes or consumed alcohol
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, 120-749, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong Ho Lee, Ph.D.
Yonsei University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 13, 2010
First Posted
October 15, 2010
Study Start
July 1, 2009
Primary Completion
April 1, 2010
Study Completion
September 1, 2010
Last Updated
October 15, 2010
Record last verified: 2009-06