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

May 20, 2026 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteer
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome is the measure of the evolution of the macular pigment density after 10 weeks of supplementation compared with the initial measure.
Time Frame: 10 weeks after inclusion
10 weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
The measure of the evolution of the plasmatic rate of zeaxanthin after10 weeks of supplementation
Time Frame: 10 weeks after inclusion
10 weeks after inclusion
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
Time Frame: 10 weeks after inclusion
10 weeks after inclusion
The measure of plasmatic rate of total cholesterol, HDL-cholesterol, triglycerides, lutein and zeaxanthin, initial and in 6 and 10 weeks of supplementation
Time Frame: 10 weeks after inclusion
10 weeks after inclusion
In the inclusion, the measure of the visual acuity and the examination of the fundus oculi.
Time Frame: 10 weeks after inclusion
10 weeks after inclusion
In the inclusion, the measure of the retinal thickness with OCT (Optical Coherence Tomography)
Time Frame: 10 weeks after inclusion
10 weeks after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Vilmorin & Cie

Investigators

  • Principal Investigator: Jean-François KOROBELNIK, MD-PhD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimated)

April 14, 2014

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2013/17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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