The Effects of a Carotenoid Intervention on Cognitive Function

Study Overview
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Brief Summary
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Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider variety of methods (behavioral testing and neuroimaging).

Detailed Description
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Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider variety of methods (behavioral testing and neuroimaging).

Official Title
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The Effects of a Lutein + Zeaxanthin Intervention on Cognitive Function and Neural Efficiency

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Dietary Supplement: active supplement
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: visual acuity correctable to 20:40 or better, Snellen notation able to swallow a dietary supplement free of dementia, characterized by a score of less than 1.5 on the Clinical Dementia Rating Scale Exclusion Criteria: GI conditions that interfere with lipid absorption presence of or past diagnosis of age-related macular degeneration visual acuity poorer than 20:40, Snellen notation has taken lutein, omega-3 fatty acid or fish oil supplements within the last 6 months presence of dementia, characterized by a score of 1.5 or greater on the Clinical Dementia Rating Scale

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 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: Active supplement<br>10 mg lutein + 2 mg zeaxanthin | Dietary Supplement: active supplement<br>* tablet<br>* Other names: FloraGlo lutein;|
| Placebo Comparator: inert placebo<br>placebo for comparison | Other: placebo<br>* tablet<br>* Other names: inert placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macular pigment optical density | optical density of macular pigment layer in central retina, defined in log units of optical density | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum carotenoid levels | serum carotenoids will be measured via high performance liquid chromatography | 12 months | 
| reaction time | reaction (msec) to a light stimulus | 12-months | 
| executive function | computerized composite score from computerized battery | 12-months | 
| short-term memory | composite score from a computerized battery | 12-months | 
| visual attention | composite score from computerized battery | 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lutein, cognition, neural efficiency, aging