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Completed

NCT Number: NCT00449917

"Visiobiane Anti-age" Effects on Vision Parameters

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.

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Key information

Conditions

Macular Pigment Optical Density

Age range

45 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

CRNH Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63009, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lutein

Drug

DHA

Drug

vitamins

Drug

Primary outcomes

  1. macular pigment optical density

Secondary outcomes

  1. contrast sensibility

  2. visual acuity

  3. seric carotenoids concentrations

  4. total antioxidant capacity

  5. influence of SR-B1 genetic polimorphism

Sponsors and collaborators

Lead sponsor

PiLeJe

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 21, 2007
Registry last updated
Oct 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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