NCT02023645

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

3.7 years

First QC Date

December 16, 2013

Last Update Submit

May 26, 2015

Conditions

Mild Cognitive Impairment

Keywords

luteincognitionneural efficiencyaging

Outcome Measures

Primary Outcomes (1)

  • macular pigment optical density

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

    12 months

Secondary Outcomes (5)

  • serum carotenoid levels

    12 months

  • reaction time

    12-months

  • executive function

    12-months

  • short-term memory

    12-months

  • visual attention

    12-months

Study Arms (2)

Active supplement

EXPERIMENTAL

10 mg lutein + 2 mg zeaxanthin

Dietary Supplement: active supplement

inert placebo

PLACEBO COMPARATOR

placebo for comparison

Other: placebo

Interventions

active supplementDIETARY_SUPPLEMENT

tablet

Also known as: FloraGlo lutein
Active supplement
placeboOTHER

tablet

Also known as: inert placebo
inert placebo

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Georgia

Athens, Georgia, 30602, United States

Location

Related Publications (1)

  • 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.

    PMID: 31871787DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Billy R Hammond, Ph.D.

    The University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Principal Investigator

Study Record Dates

First Submitted

December 16, 2013

First Posted

December 30, 2013

Study Start

January 1, 2012

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

US(1)