"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
  Purpose

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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   45 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00449917     History of Changes
Other Study ID Numbers: P11
Study First Received: March 20, 2007
Last Updated: October 5, 2011
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

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

Additional relevant MeSH terms:
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014