Nutrof Total
Dietary Supplement2 capsules 2 times per day during 6 month
NCT Number: NCT01269697
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.
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Notify Me40 year–70 year
All sexes
Interventional
Phase 3
Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin, Bordeaux, France
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 capsules 2 times per day during 6 month
2 capsules 2 times per day during 6 month
Time frame: 6 months after stop of the supplementation
Difference in measures of the density of the macular pigment at baseline and 6 months after stop of the supplementation
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 1 year
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
University Hospital, Bordeaux
Other
Acronym: LIMPIA
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