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

Primary Purpose

Age Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Corn zeaxanthin
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Age Macular Degeneration focused on measuring corn, macular pigment, lutein, zeaxanthin, Age Macular Degeneration, AMD

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts 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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy volunteer

Arm Description

Outcomes

Primary Outcome Measures

The primary outcome is the measure of the evolution of the macular pigment density after 10 weeks of supplementation compared with the initial measure.

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2014
Last Updated
October 22, 2014
Sponsor
University Hospital, Bordeaux
Collaborators
Vilmorin & Cie
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1. Study Identification

Unique Protocol Identification Number
NCT02113254
Brief Title
Study of the Macular Pigment by the Consumption of Corn With Strong Content in Zeaxanthine
Acronym
MAIS
Official Title
Study of Modification of the Density of the Macular Pigment by the Consumption of Corn With Strong Content in Zeaxanthine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Vilmorin & Cie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Macular Degeneration
Keywords
corn, macular pigment, lutein, zeaxanthin, Age Macular Degeneration, AMD

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteer
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Corn zeaxanthin
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The measure of the evolution of the plasmatic rate of zeaxanthin after10 weeks of supplementation
Time Frame
10 weeks after inclusion
Title
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
Title
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
Title
In the inclusion, the measure of the visual acuity and the examination of the fundus oculi.
Time Frame
10 weeks after inclusion
Title
In the inclusion, the measure of the retinal thickness with OCT (Optical Coherence Tomography)
Time Frame
10 weeks after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François KOROBELNIK, MD-PhD
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

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

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