The Effects of a Carotenoid Intervention on Cognitive Function

Not Applicable

• Conditions: Mild Cognitive Impairment
• Interventions: Dietary Supplement: active supplement; Other: placebo

• Registration Number: NCT02023645
• Lead Sponsor: University of Georgia

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27
• Primary Completion: 2015-09
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active supplement	active supplement	10 mg lutein + 2 mg zeaxanthin
inert placebo	placebo	placebo for comparison

Primary Outcome Measures

Name	Time	Method
macular pigment optical density	12 months	optical density of macular pigment layer in central retina, defined in log units of optical density

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Georgia; 🇺🇸 Athens, Georgia, United States