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"Visiobiane Anti-age" Effects on Vision Parameters

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ClinicalTrials.gov Identifier: NCT00449917
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : October 6, 2011
Sponsor:
Information provided by:

Study Description
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 Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Primary Completion Date : July 2007
Study Completion Date : November 2007
Arms and Interventions


Outcome Measures

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

Eligibility Criteria

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
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00449917


Locations
France
CRNH Clermont-Ferrand
Clermont-Ferrand, Auvergne, France, 63009
Sponsors and Collaborators
Pileje
Investigators
Principal Investigator: Franck Bacin, MD University Hospital, Clermont-Ferrand
More Information

ClinicalTrials.gov 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
lutein
docosahexaenoic acid (DHA)