"Visiobiane Anti-age" Effects on Vision Parameters

• Sponsor: PiLeJe (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00449917
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Pigment Optical Density	Drug: lutein; Drug: DHA; Drug: vitamins	Phase 4

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• Official Title: Study of the Effects of "Visiobiane Anti-age" Dietary Supplement on Macular Pigment Optical Density, Contrast Sensibility and Visual Acuity
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Outcome Measures

Primary Outcome Measures

1. macular pigment optical density []

Secondary Outcome Measures

1. contrast sensibility []

2. visual acuity []

3. seric carotenoids concentrations []

4. total antioxidant capacity []

5. influence of SR-B1 genetic polimorphism []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRNH Clermont-Ferrand	Clermont-Ferrand	Auvergne	France	63009

Sponsors and Collaborators

• PiLeJe

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00449917
• Other Study ID Numbers: P11
• First Posted: Mar 21, 2007
• Last Update Posted: Oct 6, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by , ,: visual caracteristics; macular pigment optical density; visual acuity; contrast sensibility; lutein; docosahexaenoic acid (DHA)

Study Results

No Results Posted as of Oct 6, 2011