"Visiobiane Anti-age" Effects on Vision Parameters

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. Identifier: NCT00449917
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : October 6, 2011
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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.

Condition or disease Intervention/treatment Phase
Macular Pigment Optical Density Drug: lutein Drug: DHA Drug: vitamins Phase 4

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Study of the Effects of "Visiobiane Anti-age" Dietary Supplement on Macular Pigment Optical Density, Contrast Sensibility and Visual Acuity
Study Start Date : September 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : November 2007

Primary Outcome Measures :
  1. macular pigment optical density

Secondary Outcome Measures :
  1. contrast sensibility
  2. visual acuity
  3. seric carotenoids concentrations
  4. total antioxidant capacity
  5. influence of SR-B1 genetic polimorphism

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00449917

CRNH Clermont-Ferrand
Clermont-Ferrand, Auvergne, France, 63009
Sponsors and Collaborators
Principal Investigator: Franck Bacin, MD University Hospital, Clermont-Ferrand Identifier: NCT00449917     History of Changes
Other Study ID Numbers: P11
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011

Keywords provided by Pileje:
visual caracteristics
macular pigment optical density
visual acuity
contrast sensibility
docosahexaenoic acid (DHA)