Age Macular Degeneration Clinical Trial
— MAISOfficial title:
Study of Modification of the Density of the Macular Pigment by the Consumption of Corn With Strong Content in Zeaxanthine
The Age Macular Degeneration (AMD) is the first cause of blindness in industrialized countries. The macular pigment (lutein and zeaxanthin) could play an important role in the arisen of the AMD. The food supplementation by corn with strong concentration in macular pigment could increase the density of the macular pigment. This could, in the future, represent a strategy of prevention of the AMD. The main objective of this study is to detect an increase of the macular pigment density after the consumption of this corn at healthy volunteers.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 35 Years |
| Eligibility |
Inclusion criteria: - Healthy volunteers, men and women - Corrected visual acuity upper or equal to 8/10 in two eyes. - Age: 20 - 35 years - Free and written consent signed by the participant and the investigator before any examination required by the research - Subject agreeing to be registered in the national file - Affiliated subject of a national insurance scheme Exclusion criteria: - Presence of AMD signs on one or two eyes - Histories of other evolutionary ocular pathologies susceptible to complicate the evaluation of the AMD and of the visual acuity (glaucoma, high myopia forte (>= - 6 dioptres), strong retinopathy…) - Subject operated of de cataract - Lens Opacities (NO>=3, et/ou NC>=3, et/ou C>=1 et/ou P>=1 according to the LOCSII method) - Food complements in the year wich precedes (list of complements in appendix 2) - Hypersensitive people in the tropicamide, in the atropine, its by-products, or in one of the excipients of the tropicamide - Patients at risk of angle closure glaucoma - Body Masse Index >= 30 kg/m2 - Current smoking or stop for less than 12 months - Diabetes - High blood pressure - Hyperlipidemia - Neuro-inflammatory diseases - Chronical gastro-intestinal diseases (Crohn …) - Taking of continuous medicine during more than one month, during the last 12 months (exception of the contraceptive pill) - Pregnant or breast-feeding woman - Vegetarian Patient - Participation in another clinical trial during 30 days wich precedes - Not compliant subjects - Subject without french national insurance scheme - Subject under guardianship judicial |
Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Bordeaux | Bordeaux |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Bordeaux | Vilmorin & Cie |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary outcome is the measure of the evolution of the macular pigment density after 10 weeks of supplementation compared with the initial measure. | 10 weeks after inclusion | No | |
| Secondary | The measure of the evolution of the plasmatic rate of zeaxanthin after10 weeks of supplementation | 10 weeks after inclusion | No | |
| Secondary | The measure of the macular pigment density before supplementation in 3, 6, 8, and 10 weeks of supplementation and after 4 weeks of stop by three methods: the sensibility in colours and two methods of autofluorescence | 10 weeks after inclusion | No | |
| Secondary | The measure of plasmatic rate of total cholesterol, HDL-cholesterol, triglycerides, lutein and zeaxanthin, initial and in 6 and 10 weeks of supplementation | 10 weeks after inclusion | No | |
| Secondary | In the inclusion, the measure of the visual acuity and the examination of the fundus oculi. | 10 weeks after inclusion | No | |
| Secondary | In the inclusion, the measure of the retinal thickness with OCT (Optical Coherence Tomography) | 10 weeks after inclusion | No |