"Visiobiane Anti-age" Effects on Vision Parameters

Phase 4

Completed

• Conditions: Macular Pigment Optical Density

• Registration Number: NCT00449917
• Lead Sponsor: PiLeJe

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.

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-03-20
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-21
• Primary Completion: 2007-07
• Study Completion: 2007-11
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-05
• Last Update Posted: 2011-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
macular pigment optical density

Secondary Outcome Measures

Name	Time	Method
contrast sensibility
visual acuity
seric carotenoids concentrations
total antioxidant capacity
influence of SR-B1 genetic polimorphism

Trial Locations

Locations (1)

CRNH Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne, France