Clinical Trials Logo
  1. Home
  2. Healthy Men
  3. NCT01221558

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 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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01221558
Study type Interventional
Source Yonsei University
Contact
Status Completed
Phase Phase 3
Start date July 2009
Completion date September 2010
View Details
See also
  Status Clinical Trial Phase
Completed NCT02575209 - Gender Differences in Social Cognition in Patients With Schizophrenia of Recent Diagnosis and Healthy Controls Subjects N/A
Completed NCT00900107 - Time-Dependent Mobilization of Circulating Progenitor Cells During Strenuous Exercise in Healthy Individuals N/A
Completed NCT02517775 - Effects of Cranberry Consumption in Vascular Function in Healthy Individuals N/A
Active, not recruiting NCT03298373 - 28-Day Repeat-Dose, Dose Escalation Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men Phase 1
Completed NCT03339167 - Metabolic Availability of Lysine From Millet in Adult Men N/A
Completed NCT01710280 - Palmitic Acid in the Sn-2 Position of Triacylglycerols and Postprandial Lipemia N/A
Completed NCT01130948 - Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects N/A
Completed NCT01382069 - Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men Phase 1
Recruiting NCT05523674 - Effects of Warm-up Intensity and Blood Flow Restriction N/A
Not yet recruiting NCT05865574 - A Comparative Pharmacokinetic Study to Evaluate Different Manufacturing Batches of BAT1706 Injection Phase 1
Completed NCT01293591 - Garlic Intake And Biomarkers Of Cancer Risk N/A
Completed NCT01296997 - Calcium Phosphate and Incretins N/A
Completed NCT00935662 - A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses Phase 1
Active, not recruiting NCT05825781 - Study, Evaluating Pharmacokinetics, Immunogenicity and Safety Profiles of Pertuzumab Compared to Perjeta® in Healthy Man Phase 1
Completed NCT02994602 - Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males Phase 1
Completed NCT02365987 - The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety N/A
Completed NCT02072278 - Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects Phase 1
Completed NCT02093169 - D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound Phase 1
Completed NCT03411005 - Metabolic Availability of Lysine From Sorghum in Adult Men N/A
Recruiting NCT02927210 - Injectable DMAU for Male Contraception in Healthy Male Volunteers (CCN015) Phase 1