Study of the Macular Pigment by the Consumption of Corn With Strong Content in Zeaxanthine (MAIS)

University Hospital of Bordeaux

Status

Completed

Conditions

Age Macular Degeneration

Treatments

Other: Corn zeaxanthin

Study type

Interventional

Funder types

Other

Identifiers

NCT02113254

CHUBX 2013/17

Details and patient eligibility

About

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.

Full description

The age macular degeneration represents the first cause of blindness in industrialized countries if it is not treated. In France, the AMD affects 600 000 persons and this figure should continue to increase, notably because of the increase of the life expectancy. The macula is responsible of the fine vision, the vision of colours and the perception of contrasts. The macular pigment is present only at the level of the macular area. This pigment is composed of three carotenoids: lutein, zeaxanthin, meso-zeaxanthin. The first two compounds are of strictly food origin and are not produced in an endogenous way. A change of the macular pigment density and/or the quality of the macular pigment is suspected to play a role in the appearance and the evolution 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. The treatment will consist in a daily consumption of a box of 125g of corn with strong zeaxanthin content during 10 weeks. This corresponds to a daily contribution of at least 1,2 mg of lutein and 2,2 mg de zeaxanthin. After the inclusion visit, the subject will be seen 5 times (after 3, 6, 8, 10, 14 weeks of treatment). In all these visits, measures of the macular pigment will be realized. A blood sample will be realized at the inclusion visit and during the visit at 6 and 10 weeks.

Enrollment

9 patients

Sex

All

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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