The Effects of a Carotenoid Intervention on Cognitive Function

May 26, 2015 updated by: Billy R. Hammond, University of Georgia

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Athens, Georgia, United States, 30602
        • The University of Georgia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active supplement
10 mg lutein + 2 mg zeaxanthin
Dietary supplement: active supplement
tablet
Other Names:
  • FloraGlo lutein
Placebo Comparator: inert placebo
placebo for comparison
Other: placebo
tablet
Other Names:
  • inert placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
macular pigment optical density
Time Frame: 12 months
optical density of macular pigment layer in central retina, defined in log units of optical density
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Georgia

Collaborators

Abbott Nutrition
DSM Nutritional Products, Inc.

Investigators

  • Principal Investigator: Billy R Hammond, Ph.D., The University of Georgia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (Estimate)

December 30, 2013

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-10516

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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