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

NCT ID: NCT02113254

Last Updated: 2014-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-06-30

Brief Summary

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.

Detailed 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.

Conditions

Age Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy volunteer

Group Type: EXPERIMENTAL

Corn zeaxanthin

Intervention Type: OTHER

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

Interventions

Corn zeaxanthin

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vilmorin & Cie

UNKNOWN

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-François KOROBELNIK, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2013/17

Identifier Type: -

Identifier Source: org_study_id