Lutein Influence on Macula of Persons Issued From Amd Parents

Study Overview
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Brief Summary
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Age-related macular degeneration (AMD) is a degenerative disease of the centre of the retina (named macula) and is the leading cause of blindness in industrialized countries. There is growing interest in the potential preventive role of two carotenoids (lutein and zeaxanthin) of dietary origin, which specifically accumulate in the macula, where they form the macular pigment. A first step towards the demonstration of a preventive effect of macular pigment for AMD consists in the evaluation of the effect of lutein and zeaxanthin supplementation on their plasma and retinal concentrations.

Detailed Description
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The objective of this study is to estimate the efficiency of a nutritonal supplementation with lutein and zeaxanthin to increase their plasma concentration and the density of macular pigment, in subjects at high genetic risk for AMD (1st generation stemming from parent affected by DMLA). This study is a multicentric, double blind, randomized clinical trial of supplementation versus placebo

Official Title
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Lutein Influence on Macula of Persons Issued From Amd Parents

Conditions
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Persons Issued From Amd Parents

Intervention / Treatment
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* Dietary Supplement: Nutrof Total
* Dietary Supplement: Placebo Nutrof total


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women 40 to 70 years old Presenting histories of wet AMD with their father or their mother or 2 Visual acuity of 20/25 or better (ETDRS) The presence of a AMD in one eye is possible Enlightened consent writes, dated and signed by the participant and the investigator above all examination required by the research. Subject agreeing to be registered in the national file Affiliated or profitable subject of a national insurance scheme Exclusion Criteria: Presence of signs of AMD in both eyes (if AMD in one eye, inclusion for the other eye is possible) Histories of the other evolutionary eye pathologies susceptible to complicate the evaluation of the AMD and of the visual acuity (severe glaucoma, strong nearsightedness (superior or more equal in - 6 dioptres), the other severe rétinopathie) Subject with history of cataract surgery Opaqueness preventing the evaluation of the photos of the retina (cataract, corneal dystrophy) Supplementation with food complements in the year which precedes (cf. appendix 2 of the protocol) Participation in another clinical trial during 30 days which precede Subjects not compliants Subjects not flatware by the system of social security Subjects under guardianship judicial

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutrof<br>patient receive the treatment of Nutrof Total | Dietary Supplement: Nutrof Total<br>* 2 capsules 2 times per day during 6 month<br>|
| Placebo Comparator: Placebo of Nutrof<br>Patient receive the treatment of the placebo of Nutrof Total | Dietary Supplement: Placebo Nutrof total<br>* 2 capsules 2 times per day during 6 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main assessment criterion is the measure of the evolution of the density of the macular pigment after 6 months of supplementation | Difference in measures of the density of the macular pigment at baseline and 6 months after stop of the supplementation | 6 months after stop of the supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the modification of the visual acuteness with correction |  | 12 months | 
| Measure of the cognitive capacities |  | 12 months | 
| Measure rates plasmatiques of fatty acids |  | 12 months | 
| Measure of the evolution of the density of the macular pigment during supplementation and after stop of the supplementation | Measure of the density of the macular pigment before supplementation, in 3 and 6 months during the supplementation and in 3 and 6 months after stop of the supplementation | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, food supplementation, macular pigments, luthéine, zéaxanthine, visual acuity, prevention, genetique risk