The Effects of a Lutein + Zeaxanthin Intervention on Cognitive Function and Neural Efficiency
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Georgia
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- macular pigment optical density
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Active supplement
10 mg lutein + 2 mg zeaxanthin
Intervention: active supplement (Dietary Supplement)
inert placebo
placebo for comparison
Intervention: placebo (Other)
Outcomes
Primary Outcomes
macular pigment optical density
Time Frame: 12 months
optical density of macular pigment layer in central retina, defined in log units of optical density
Secondary Outcomes
- reaction time(12-months)
- serum carotenoid levels(12 months)
- executive function(12-months)
- short-term memory(12-months)
- visual attention(12-months)
Investigators
Billy R. Hammond
Professor and Principal Investigator
University of Georgia