The Effects of a Zeaxanthin Intervention on Visuomotor Function

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).

Study Overview

• Status: Completed
• Conditions: Behavior and Behavior Mechanisms
• Intervention / Treatment: Dietary supplement: zeaxanthin; Dietary supplement: combinatory supplement

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30602
      • Department of Psychology, UGA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: zeaxanthin; placebo zeaxanthin	Dietary supplement: zeaxanthin; softgel
ACTIVE_COMPARATOR: combinatory supplement; placebo combinatory supplement	Dietary supplement: combinatory supplement; softgel; Other Names: zeaxanthin + lutein + DHA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	12-months
coincidence anticipation	button press when a light stimulus of varying speeds reaches a specific point in a linear light array	12-months

Collaborators and Investigators

• Sponsor: University of Georgia
• Collaborators: ZeaVision, LLC
• Investigators: Principal Investigator: Billy R Hammond, Ph.D., University of Georgia

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: December 16, 2013
• First Posted (ESTIMATE): December 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: reaction time; zeaxanthin; visual function; processing speed
• Other Study ID Numbers: 2012-10531