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"Visiobiane Anti-age" Effects on Vision Parameters

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00449917
First Posted: March 21, 2007
Last Update Posted: October 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pileje
March 20, 2007
March 21, 2007
October 6, 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
Intervention Model: Parallel Assignment
Masking: Double
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
Sexes Eligible for Study: Male
45 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00449917
P11
No
Not Provided
Not Provided
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