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The Effects of a Carotenoid Intervention on Cognitive Function

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
active supplement
placebo
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mild Cognitive Impairment focused on measuring lutein, cognition, neural efficiency, aging

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Georgia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active supplement

inert placebo

Arm Description

10 mg lutein + 2 mg zeaxanthin

placebo for comparison

Outcomes

Primary Outcome Measures

macular pigment optical density
optical density of macular pigment layer in central retina, defined in log units of optical density

Secondary Outcome Measures

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

Full Information

First Posted
December 16, 2013
Last Updated
May 26, 2015
Sponsor
University of Georgia
Collaborators
Abbott Nutrition, DSM Nutritional Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02023645
Brief Title
The Effects of a Carotenoid Intervention on Cognitive Function
Official Title
The Effects of a Lutein + Zeaxanthin Intervention on Cognitive Function and Neural Efficiency
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
Collaborators
Abbott Nutrition, DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
lutein, cognition, neural efficiency, aging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active supplement
Arm Type
Experimental
Arm Description
10 mg lutein + 2 mg zeaxanthin
Arm Title
inert placebo
Arm Type
Placebo Comparator
Arm Description
placebo for comparison
Intervention Type
Dietary Supplement
Intervention Name(s)
active supplement
Other Intervention Name(s)
FloraGlo lutein
Intervention Description
tablet
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
inert placebo
Intervention Description
tablet
Primary Outcome Measure Information:
Title
macular pigment optical density
Description
optical density of macular pigment layer in central retina, defined in log units of optical density
Time Frame
12 months
Secondary Outcome Measure Information:
Title
serum carotenoid levels
Description
serum carotenoids will be measured via high performance liquid chromatography
Time Frame
12 months
Title
reaction time
Description
reaction (msec) to a light stimulus
Time Frame
12-months
Title
executive function
Description
computerized composite score from computerized battery
Time Frame
12-months
Title
short-term memory
Description
composite score from a computerized battery
Time Frame
12-months
Title
visual attention
Description
composite score from computerized battery
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Billy R Hammond, Ph.D.
Organizational Affiliation
The University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31871787
Citation
Mewborn CM, Lindbergh CA, Hammond BR, Renzi-Hammond LM, Miller LS. The Effects of Lutein and Zeaxanthin Supplementation on Brain Morphology in Older Adults: A Randomized, Controlled Trial. J Aging Res. 2019 Dec 1;2019:3709402. doi: 10.1155/2019/3709402. eCollection 2019.
Results Reference
derived

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The Effects of a Carotenoid Intervention on Cognitive Function

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