The Effects of a Zeaxanthin Intervention on Visuomotor Fu... | NCT02017418

Studies
The Effects of a Zeaxanthin Intervention on Visuomotor Function

NCT02017418

Sponsor

University of Georgia

Status

Completed

Last Update Posted

May 27, 2015Estimated

Enrollment

102Actual

Phase

Not Applicable

Conditions

Behavior and Behavior Mechanisms

Interventions

zeaxanthin
combinatory supplement

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

No data available

No data is available for this block.

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Dec 16, 2013

First Submission Date that Met QC Criteria

Dec 16, 2013

First Posted Date

Dec 20, 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

Name	Class
ZeaVision, LLC	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

This study was designed to test whether two zeaxanthin formulations (supplements containing different nutritional compounds with zeaxanthin and omega fatty acids being the primary ingredients of interest) influenced visual motor function. Visual motor function refers to the processing speed of the visual system and how individuals respond behavioral to visual stimuli (e.g., reaction time).

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

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
zeaxanthin	Experimental	placebo zeaxanthin	Dietary Supplement: zeaxanthin
combinatory supplement	Active Comparator	placebo combinatory supplement	Dietary Supplement: combinatory supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
zeaxanthin	Dietary Supplement	softgel	zeaxanthin
combinatory supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Macular pigment optical density	Increases in the amount of macular pigment measured in optical density units	one year

Secondary Outcomes

Measure	Description	Time Frame
fixed reaction time	reaction time to a stimulus fixed in space	one year
variable reaction time	reaction time to a stimulus with a position that varies in space

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: ≥18 and ≤ 40 years
BMI: ≥ 20 and ≤ 30 kg/m2
No anticipated changes in dieting habits (as relevant to the intake of xanthophylls and fats/oils).
No anticipated surgical procedures.
Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.
Corrected visual acuity (ETDRS): better than 20/60 in the eye selected for the study

Exclusion Criteria:

Smokers
Current or history of relevant ocular diseases (such as AMD) or other conditions e.g., lipid disorders.
Inability to reliably perform macular pigment optical density measurements by "Heterochromatic Flicker Photometry" or any of the other ophthalmic tests of the study.
Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls (e.g., digestive disorders: inflammatory bowel disease, ulcerative colitis, Crohn's, irritable bowel, etc. or lipid disorders including conditions such as hypercholesterolemia)
Current use of xanthophyll containing supplements or use of xanthophyll containing supplements in the past 6 months (but excluding multivitamins containing lutein or zeaxanthin at low potency).
Participation in any other study during last 1 month before study initiation.
Known hypersensitivity or allergy to xanthophylls.
Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes. These include diabetes medication and statins or any other drug/supplement to modulate cholesterol or fat digestion/absorption.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D065146	Zeaxanthins
D014975	Lutein

ID	Term
D024341	Xanthophylls
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839