The Effects of a Zeaxanthin Intervention on Visuomotor Function

Study Overview
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Brief Summary
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This study was designed to test whether two zeaxanthin formulations (supplements containing different nutritional compounds with zeaxanthin and omega fatty acids being the primary ingredients of interest) influenced visual motor function. Visual motor function refers to the processing speed of the visual system and how individuals respond behavioral to visual stimuli (e.g., reaction time).

Detailed Description
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This study was designed to test whether two zeaxanthin formulations (supplements containing different nutritional compounds with zeaxanthin and omega fatty acids being the primary ingredients of interest) influenced visual motor function. Visual motor function refers to the processing speed of the visual system and how individuals respond behavioral to visual stimuli (e.g., reaction time).

Official Title
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The Effects of a Zeaxanthin Intervention on Visuomotor Function

Conditions
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Behavior and Behavior Mechanisms

Intervention / Treatment
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* Dietary Supplement: zeaxanthin
* Dietary Supplement: combinatory supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: ≥18 and ≤ 40 years BMI: ≥ 20 and ≤ 30 kg/m2 No anticipated changes in dieting habits (as relevant to the intake of xanthophylls and fats/oils). No anticipated surgical procedures. Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements. Corrected visual acuity (ETDRS): better than 20/60 in the eye selected for the study Exclusion Criteria: Smokers Current or history of relevant ocular diseases (such as AMD) or other conditions e.g., lipid disorders. Inability to reliably perform macular pigment optical density measurements by Heterochromatic Flicker Photometry or any of the other ophthalmic tests of the study. Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls (e.g., digestive disorders: inflammatory bowel disease, ulcerative colitis, Crohn's, irritable bowel, etc. or lipid disorders including conditions such as hypercholesterolemia) Current use of xanthophyll containing supplements or use of xanthophyll containing supplements in the past 6 months (but excluding multivitamins containing lutein or zeaxanthin at low potency). Participation in any other study during last 1 month before study initiation. Known hypersensitivity or allergy to xanthophylls. Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes. These include diabetes medication and statins or any other drug/supplement to modulate cholesterol or fat digestion/absorption.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zeaxanthin<br>placebo zeaxanthin | Dietary Supplement: zeaxanthin<br>* softgel<br>|
| Active Comparator: combinatory supplement<br>placebo combinatory supplement | Dietary Supplement: combinatory supplement<br>* softgel<br>* Other names: zeaxanthin + lutein + DHA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular pigment optical density | Increases in the amount of macular pigment measured in optical density units | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fixed reaction time | reaction time to a stimulus fixed in space | one year | 
| variable reaction time | reaction time to a stimulus with a position that varies in space | 12-months | 
| coincidence anticipation | button press when a light stimulus of varying speeds reaches a specific point in a linear light array | 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zeaxanthin, visual function, reaction time, processing speed