"Visiobiane Anti-age" Effects on Vision Parameters

October 5, 2011 updated by: PiLeJe

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

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.

Study Overview

Status

Completed

Conditions

Macular Pigment Optical Density

Intervention / Treatment

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 Type

Interventional

Enrollment

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- Auvergne
  - Clermont-Ferrand, Auvergne, France, 63009
    - CRNH Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 55 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
macular pigment optical density

Secondary Outcome Measures

Outcome Measure
contrast sensibility
visual acuity
seric carotenoids concentrations
total antioxidant capacity
influence of SR-B1 genetic polimorphism

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PiLeJe

Investigators

Principal Investigator: Franck Bacin, MD, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 20, 2007

First Posted (Estimate)

March 21, 2007

Study Record Updates

Last Update Posted (Estimate)

October 6, 2011

Last Update Submitted That Met QC Criteria

October 5, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.