NCT02017418

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.4 years

First QC Date

December 16, 2013

Last Update Submit

May 26, 2015

Conditions

Behavior and Behavior Mechanisms

Keywords

zeaxanthinvisual functionreaction timeprocessing speed

Outcome Measures

Primary Outcomes (1)

  • Macular pigment optical density

    Increases in the amount of macular pigment measured in optical density units

    one year

Secondary Outcomes (3)

  • fixed reaction time

    one year

  • variable reaction time

    12-months

  • coincidence anticipation

    12-months

Study Arms (2)

zeaxanthin

EXPERIMENTAL

placebo zeaxanthin

Dietary Supplement: zeaxanthin

combinatory supplement

ACTIVE COMPARATOR

placebo combinatory supplement

Dietary Supplement: combinatory supplement

Interventions

zeaxanthinDIETARY_SUPPLEMENT

softgel

zeaxanthin
combinatory supplementDIETARY_SUPPLEMENT

softgel

Also known as: zeaxanthin + lutein + DHA
combinatory supplement

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, UGA

Athens, Georgia, 30602, United States

Location

MeSH Terms

Conditions

Behavior

Interventions

ZeaxanthinsLutein

Intervention Hierarchy (Ancestors)

XanthophyllsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Billy R Hammond, Ph.D.

    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 20, 2013

Study Start

February 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

US(1)