The Effects of a Carotenoid Intervention on Cognitive Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-12-31

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).

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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).

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active supplement

10 mg lutein + 2 mg zeaxanthin

Group Type EXPERIMENTAL

active supplement

Intervention Type DIETARY_SUPPLEMENT

tablet

inert placebo

placebo for comparison

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

tablet

Interventions

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active supplement

tablet

Intervention Type DIETARY_SUPPLEMENT

placebo

tablet

Intervention Type OTHER

Other Intervention Names

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FloraGlo lutein inert placebo

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes