- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02113254
Study of the Macular Pigment by the Consumption of Corn With Strong Content in Zeaxanthine (MAIS)
October 22, 2014 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
Completed
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
-
-
-
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
Genders Eligible for Study
All
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
|
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
Collaborators
Investigators
- Principal Investigator: Jean-François KOROBELNIK, MD-PhD, CHU 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 (Estimate)
April 14, 2014
Study Record Updates
Last Update Posted (Estimate)
October 23, 2014
Last Update Submitted That Met QC Criteria
October 22, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
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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