TerminatedNot Applicable

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

Stopped: target number of inclusion not reached

France9 participantsStarted 2014-02

Plain-language 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.

Who can participate

Age range

20 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 subje…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 10 weeks after inclusion

Trial details

NCT IDNCT02113254

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Age Macular Degeneration trials