The Effects of a Zeaxanthin Intervention on Visuomotor Function

Behavior and Behavior Mechanisms Clinical Trial

Official title:

The Effects of a Zeaxanthin Intervention on Visuomotor Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017418
• Other study ID #: 2012-10531
• Status: Completed
• Phase: N/A
• First received: December 16, 2013
• Last updated: May 26, 2015
• Start date: February 2012
• Est. completion date: July 2014

Study information

• Verified date: May 2015
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms

Intervention

Dietary Supplement:
• zeaxanthin
softgel
• combinatory supplement
softgel

Locations

Country	Name	City	State
United States	Department of Psychology, UGA	Athens	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
University of Georgia	ZeaVision, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular pigment optical density	Increases in the amount of macular pigment measured in optical density units	one year	No
Secondary	fixed reaction time	reaction time to a stimulus fixed in space	one year	No
Secondary	variable reaction time	reaction time to a stimulus with a position that varies in space	12-months	No
Secondary	coincidence anticipation	button press when a light stimulus of varying speeds reaches a specific point in a linear light array	12-months	No