Clinical trial NCT02017418: The Effects of a Zeaxanthin Intervention on Visuomotor Function
Official title: The Effects of a Zeaxanthin Intervention on Visuomotor Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior and Behavior Mechanisms
Keywords: zeaxanthin
visual function
reaction time
processing speed
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: ZeaVision, LLC
First posted: 2013-12-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

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.

Primary outcomes:
measure: Macular pigment optical density
timeFrame: one year
Secondary outcomes:
measure: fixed reaction time
timeFrame: one year
measure: variable reaction time
timeFrame: 12-months
measure: coincidence anticipation
timeFrame: 12-months
Other outcomes:
Locations:
city: Athens
country: United States
facility: Department of Psychology, UGA
state: Georgia
Study officials:
affiliation: University of Georgia
name: Billy R Hammond, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: