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OpenTrials
Completed

NCT Number: NCT02017418

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).

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology, UGA

Athens, Georgia, 30602, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

zeaxanthin

Dietary Supplement

softgel

combinatory supplement

Dietary Supplement

softgel

Other names: zeaxanthin + lutein + DHA

Primary outcomes

  1. Macular pigment optical density

    Time frame: one year

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

Secondary outcomes

  1. fixed reaction time

    Time frame: one year

    reaction time to a stimulus fixed in space

  2. variable reaction time

    Time frame: 12-months

    reaction time to a stimulus with a position that varies in space

  3. coincidence anticipation

    Time frame: 12-months

    button press when a light stimulus of varying speeds reaches a specific point in a linear light array

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Collaborators

  • ZeaVision, LLC

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 20, 2013
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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