"Visiobiane Anti-age" Effects on Vision Parameters

Macular Pigment Optical Density Clinical Trial

Official title:

Study of the Effects of "Visiobiane Anti-age" Dietary Supplement on Macular Pigment Optical Density, Contrast Sensibility and Visual Acuity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449917
• Other study ID #: P11
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2007
• Last updated: October 5, 2011
• Start date: September 2006
• Est. completion date: November 2007

Study information

• Verified date: October 2011
• Source: Pileje
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Macular Pigment Optical Density

Intervention

Drug:
• lutein

• DHA

• vitamins

Locations

Country	Name	City	State
France	CRNH Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
Pileje

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	macular pigment optical density
Secondary	contrast sensibility
Secondary	visual acuity
Secondary	seric carotenoids concentrations
Secondary	total antioxidant capacity
Secondary	influence of SR-B1 genetic polimorphism