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"Visiobiane Anti-age" Effects on Vision Parameters

This study has been completed.
Information provided by:
Pileje Identifier:
First received: March 20, 2007
Last updated: October 5, 2011
Last verified: October 2011
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 Intervention Phase
Macular Pigment Optical Density
Drug: lutein
Drug: DHA
Drug: vitamins
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Further study details as provided by Pileje:

Primary Outcome Measures:
  • macular pigment optical density

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

Estimated Enrollment: 30
Study Start Date: September 2006
Study Completion Date: November 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00449917

CRNH Clermont-Ferrand
Clermont-Ferrand, Auvergne, France, 63009
Sponsors and Collaborators
Principal Investigator: Franck Bacin, MD University Hospital, Clermont-Ferrand
  More Information Identifier: NCT00449917     History of Changes
Other Study ID Numbers: P11
Study First Received: March 20, 2007
Last Updated: October 5, 2011

Keywords provided by Pileje:
visual caracteristics
macular pigment optical density
visual acuity
contrast sensibility
docosahexaenoic acid (DHA) processed this record on April 24, 2017