The Effects of a Carotenoid Intervention on Cognitive Fun... | NCT02023645

Studies
The Effects of a Carotenoid Intervention on Cognitive Function

NCT02023645

Sponsor

University of Georgia

Status

Unknown status

Last Update Posted

May 27, 2015Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Mild Cognitive Impairment

Interventions

active supplement
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Sep 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Dec 16, 2013

First Submission Date that Met QC Criteria

Dec 23, 2013

First Posted Date

Dec 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2015

Last Update Posted Date

May 27, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Billy R. Hammond, Professor and Principal Investigator, University of GeorgiaPrincipal Investigator

Lead Sponsor

University of GeorgiaOTHER

Collaborators

Name	Class
Abbott Nutrition	INDUSTRY
dsm-firmenich Switzerland AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active supplement	Experimental	10 mg lutein + 2 mg zeaxanthin	Dietary Supplement: active supplement
inert placebo	Placebo Comparator	placebo for comparison	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
active supplement	Dietary Supplement	tablet	Active supplement	FloraGlo lutein

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
serum carotenoid levels	serum carotenoids will be measured via high performance liquid chromatography	12 months
reaction time	reaction (msec) to a light stimulus

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Billy R Hammond, Ph.D.	The University of Georgia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Georgia		Athens	Georgia	30602	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31871787	Derived	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.

Type	Date	Date Unknown
Release	Apr 13, 2018
Reset	Nov 13, 2018
Release	May 15, 2019
Reset	Jul 22, 2019

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 13, 2018			Nov 13, 2018
May 15, 2019

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders