The Effects of a Zeaxanthin Intervention on Visuomotor Function

NCT ID: NCT02017418

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-07-31

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

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).

Conditions

Behavior and Behavior Mechanisms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

zeaxanthin

placebo zeaxanthin

Group Type: EXPERIMENTAL

zeaxanthin

Intervention Type: DIETARY_SUPPLEMENT

softgel

combinatory supplement

placebo combinatory supplement

Group Type: ACTIVE_COMPARATOR

combinatory supplement

Intervention Type: DIETARY_SUPPLEMENT

softgel

Interventions

zeaxanthin

softgel

Intervention Type: DIETARY_SUPPLEMENT

combinatory supplement

softgel

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

zeaxanthin + lutein + DHA

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ZeaVision, LLC

INDUSTRY

Sponsor Role: collaborator

University of Georgia

OTHER

Sponsor Role: lead

Responsible Party

Billy R. Hammond

Professor and Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Billy R Hammond, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Locations

Department of Psychology, UGA

Athens, Georgia, United States

Countries

United States

Other Identifiers

2012-10531

Identifier Type: -

Identifier Source: org_study_id