"Visiobiane Anti-age" Effects on Vision Parameters

This study has been completed.
Sponsor:
Information provided by:
Pileje
ClinicalTrials.gov Identifier:
NCT00449917
First received: March 20, 2007
Last updated: October 5, 2011
Last verified: October 2011

March 20, 2007
October 5, 2011
September 2006
July 2007   (final data collection date for primary outcome measure)
macular pigment optical density
Same as current
Complete list of historical versions of study NCT00449917 on ClinicalTrials.gov Archive Site
  • contrast sensibility
  • visual acuity
  • seric carotenoids concentrations
  • total antioxidant capacity
  • influence of SR-B1 genetic polimorphism
Same as current
Not Provided
Not Provided
 
"Visiobiane Anti-age" Effects on Vision Parameters
Study of the Effects of "Visiobiane Anti-age" Dietary Supplement on Macular Pigment Optical Density, Contrast Sensibility and Visual Acuity

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Macular Pigment Optical Density
  • Drug: lutein
  • Drug: DHA
  • Drug: vitamins
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2007
July 2007   (final data collection date for primary outcome measure)

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
Male
45 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00449917
P11
No
Not Provided
Pileje
Not Provided
Principal Investigator: Franck Bacin, MD University Hospital, Clermont-Ferrand
Pileje
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP