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"Visiobiane Anti-age" Effects on Vision Parameters

NCT ID: NCT00449917

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-11-30

Brief Summary

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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

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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

Conditions

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Macular Pigment Optical Density

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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lutein

Intervention Type DRUG

DHA

Intervention Type DRUG

vitamins

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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PiLeJe

INDUSTRY

Sponsor Role lead

Principal Investigators

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Franck Bacin, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CRNH Clermont-Ferrand

Clermont-Ferrand, Auvergne, France

Site Status

Countries

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France

Other Identifiers

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P11

Identifier Type: -

Identifier Source: org_study_id