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Clinical Trials/NCT00449917
NCT00449917
Completed
Phase 4

Study of the Effects of "Visiobiane Anti-age" Dietary Supplement on Macular Pigment Optical Density, Contrast Sensibility and Visual Acuity

PiLeJe1 site in 1 country30 target enrollmentSeptember 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Macular Pigment Optical Density
Sponsor
PiLeJe
Enrollment
30
Locations
1
Primary Endpoint
macular pigment optical density
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The purpose of this study is to determine the benefits of "Visiobiane Anti-age" dietary supplement on macular pigment optical density, contrast sensibility and visual acuity. Additionally, the study would like to evaluate seric variations of carotenoids and the total antioxydant capacity.

Detailed Description

Visiobiane study is a randomized trial of 30 participants designed to assess the effects of oral supplementation of macular xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs for the eyes protection. The study will enroll healthy participants aged 45 to 55 years. 15 subjects will be assigned in placebo group and 15 in experimetal group (Visiobiane anti-age). They will be supplemented for 24 weeks

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
November 2007
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
PiLeJe

Eligibility Criteria

Inclusion Criteria

  • healthy caucasian men
  • age : 45-55
  • BMI \< 25

Exclusion Criteria

  • non healthy
  • retinian and/or visual anomaly
  • Ocular media not clear enough to allow good fundus photography

Outcomes

Primary Outcomes

macular pigment optical density

Secondary Outcomes

  • contrast sensibility
  • visual acuity
  • seric carotenoids concentrations
  • total antioxidant capacity
  • influence of SR-B1 genetic polimorphism

Study Sites (1)

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