Overview

This trial is active, not recruiting.

Condition mild cognitive impairment
Treatments active supplement, placebo
Sponsor University of Georgia
Collaborator Abbott Nutrition
Start date January 2012
End date September 2015
Trial size 120 participants
Trial identifier NCT02023645, 2012-10516

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Experimental)
10 mg lutein + 2 mg zeaxanthin
active supplement FloraGlo lutein
tablet
(Placebo Comparator)
placebo for comparison
placebo inert placebo
tablet

Primary Outcomes

Measure
macular pigment optical density
time frame: 12 months

Secondary Outcomes

Measure
serum carotenoid levels
time frame: 12 months
reaction time
time frame: 12-months
executive function
time frame: 12-months
short-term memory
time frame: 12-months
visual attention
time frame: 12-months

Eligibility Criteria

Male or female participants from 18 years up to 95 years old.

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

Additional Information

Official title The Effects of a Lutein + Zeaxanthin Intervention on Cognitive Function and Neural Efficiency
Principal investigator Billy R Hammond, Ph.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Georgia.