Behavior and Behavior MechanismsNCT02017418
The Effects of a Zeaxanthin Intervention on Visuomotor Function
A study testing zeaxanthin and combinatory supplement in people with Behavior and Behavior Mechanisms, run by University of Georgia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior and Behavior Mechanisms
- What is being tested?
- zeaxanthin and combinatory supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychology, UGA
Athens, Georgia, 30602
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).
Read the 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
- Being tested
- zeaxanthin, combinatory supplement
- Keywords
- zeaxanthin, visual function, reaction time, processing speed
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zeaxanthinDietary supplement
softgel
combinatory supplementDietary supplement
Also called zeaxanthin + lutein + DHA
softgel
| Study group | Role | What they receive |
|---|---|---|
| zeaxanthin | Experimental | placebo zeaxanthin Receives: Dietary Supplement: zeaxanthin |
| combinatory supplement | Active comparator | placebo combinatory supplement Receives: Dietary Supplement: combinatory supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular pigment optical density
Increases in the amount of macular pigment measured in optical density units
Measured: one year
Secondary outcomes (3)
fixed reaction time
reaction time to a stimulus fixed in space
Measured: one year
variable reaction time
reaction time to a stimulus with a position that varies in space
Measured: 12-months
coincidence anticipation
button press when a light stimulus of varying speeds reaches a specific point in a linear light array
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startFeb 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior and Behavior MechanismsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- ZeaVision, LLC
- Responsible party
- Principal investigator, Billy R. Hammond, University of Georgia
- Investigators
- Billy R Hammond, Ph.D., Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017418
- Sponsor's protocol ID
- 2012-10531
- Status last verified
- May 2015
- First submitted
- 16 Dec 2013
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Zeaxanthin Intervention on Visuomotor Function
- ClinicalTrials.gov ID
- NCT02017418
- Acronym / sponsor ID
- 2012-10531
- Conditions
- Behavior and Behavior Mechanisms
- Keywords
- zeaxanthin, visual function, reaction time, processing speed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- ZeaVision, LLC
- Study start
- Feb 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zeaxanthin | Experimental | Dietary Supplement: zeaxanthinplacebo zeaxanthin |
| combinatory supplement | Active comparator | Dietary Supplement: combinatory supplementplacebo combinatory supplement |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zeaxanthinsoftgel | Dietary supplement | zeaxanthin |
| combinatory supplementAlso: zeaxanthin + lutein + DHAsoftgel | Dietary supplement | combinatory supplement |
Primary outcome
Macular pigment optical density
Time frame: one year
Increases in the amount of macular pigment measured in optical density units
3 secondary outcomes
fixed reaction time
Time frame: one year
variable reaction time
Time frame: 12-months
coincidence anticipation
Time frame: 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Billy R Hammond, Ph.D. principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zeaxanthin and combinatory supplement in people with Behavior and Behavior Mechanisms, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular pigment optical density (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.