NCT02113254

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 22, 2026

Status Verified

October 1, 2014

Enrollment Period

4 months

First QC Date

April 10, 2014

Last Update Submit

May 20, 2026

Conditions

Age Macular Degeneration

Keywords

cornmacular pigmentluteinzeaxanthinAge Macular DegenerationAMD

Outcome Measures

Primary Outcomes (1)

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

    10 weeks after inclusion

Secondary Outcomes (5)

  • The measure of the evolution of the plasmatic rate of zeaxanthin after10 weeks of supplementation

    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

    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

    10 weeks after inclusion

  • In the inclusion, the measure of the visual acuity and the examination of the fundus oculi.

    10 weeks after inclusion

  • In the inclusion, the measure of the retinal thickness with OCT (Optical Coherence Tomography)

    10 weeks after inclusion

Study Arms (1)

Healthy volunteer

EXPERIMENTAL
Other: Corn zeaxanthin

Interventions

Corn zeaxanthinOTHER

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

Healthy volunteer

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Callosities

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jean-François KOROBELNIK, MD-PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 14, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 22, 2026

Record last verified: 2014-10

Locations

FR(1)