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The Effects of a Carotenoid Intervention on Cognitive Function

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02023645
Enrollment
120
Registered
2013-12-30
Start date
2012-01-31
Completion date
2015-12-31
Last updated
2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

lutein, cognition, neural efficiency, aging

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).

Interventions

DIETARY_SUPPLEMENTactive supplement

tablet

OTHERplacebo

tablet

Sponsors

Abbott Nutrition
CollaboratorINDUSTRY
DSM Nutritional Products, Inc.
CollaboratorINDUSTRY
University of Georgia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
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

Design outcomes

Primary

MeasureTime frameDescription
macular pigment optical density12 monthsoptical density of macular pigment layer in central retina, defined in log units of optical density

Secondary

MeasureTime frameDescription
serum carotenoid levels12 monthsserum carotenoids will be measured via high performance liquid chromatography
reaction time12-monthsreaction (msec) to a light stimulus
executive function12-monthscomputerized composite score from computerized battery
short-term memory12-monthscomposite score from a computerized battery
visual attention12-monthscomposite score from computerized battery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026