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

Healthy Men Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221558
• Other study ID #: L-01
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2010
• Last updated: October 14, 2010
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: June 2009
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Men

Intervention

Dietary Supplement:
• lycopene

Locations

Country	Name	City	State
Korea, Republic of	Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lymphocyte DNA damage		8 weeks	Yes
Primary	antioxidant enzymes : SOD, GSH-Px, Catalase		8 weeks	Yes
Primary	lipid peroxidation marker : MDA, urinary 8 epi-PGF 2alpha		8 weeks	Yes
Primary	oxidized LDL		8 weeks	Yes
Secondary	Reactive hyperemia peripheral arterial tonometry (RH-PAT) index		8 weeks	Yes
Secondary	VCAM-1/ICAM-1		8 weeks	Yes
Secondary	cytokines : IL-6, TNF-alpha, IL-1beta		8 weeks	Yes
Secondary	hs-CRP		8 weeks	Yes