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The Effects of a Carotenoid Intervention on Cognitive Function

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ClinicalTrials.gov Identifier: NCT02023645
Recruitment Status : Unknown
Verified May 2015 by Billy R. Hammond, University of Georgia.
Recruitment status was:  Active, not recruiting
First Posted : December 30, 2013
Last Update Posted : May 27, 2015
Sponsor:
Collaborators:
Abbott Nutrition
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Billy R. Hammond, 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).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Dietary Supplement: active supplement Other: placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effects of a Lutein + Zeaxanthin Intervention on Cognitive Function and Neural Efficiency
Study Start Date : January 2012
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

Arm Intervention/treatment
Experimental: Active supplement
10 mg lutein + 2 mg zeaxanthin
Dietary Supplement: active supplement
tablet
Other Name: FloraGlo lutein

Placebo Comparator: inert placebo
placebo for comparison
Other: placebo
tablet
Other Name: inert placebo




Primary Outcome Measures :
  1. macular pigment optical density [ Time Frame: 12 months ]
    optical density of macular pigment layer in central retina, defined in log units of optical density


Secondary Outcome Measures :
  1. serum carotenoid levels [ Time Frame: 12 months ]
    serum carotenoids will be measured via high performance liquid chromatography

  2. reaction time [ Time Frame: 12-months ]
    reaction (msec) to a light stimulus

  3. executive function [ Time Frame: 12-months ]
    computerized composite score from computerized battery

  4. short-term memory [ Time Frame: 12-months ]
    composite score from a computerized battery

  5. visual attention [ Time Frame: 12-months ]
    composite score from computerized battery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023645


Locations
United States, Georgia
The University of Georgia
Athens, Georgia, United States, 30602
Sponsors and Collaborators
University of Georgia
Abbott Nutrition
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Billy R Hammond, Ph.D. The University of Georgia

Responsible Party: Billy R. Hammond, Professor and Principal Investigator, University of Georgia
ClinicalTrials.gov Identifier: NCT02023645     History of Changes
Other Study ID Numbers: 2012-10516
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Billy R. Hammond, University of Georgia:
lutein
cognition
neural efficiency
aging

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders