Eye FatigueNCT05314647
Lutein Supplementation in Healthy Children
A study testing lutein in people with Eye Fatigue and Diet, Healthy, run by Northcentral University at 1 site in United States.
Trial summary
This is a single site, randomized, double-blind placebo controlled parallel arm study assessing the effects of 6 months lutein supplementation on cognitive and visual outcomes in healthy children exposed to excessive digital screen time. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Fatigue, Diet, Healthy, Cognitive Change
- What is being tested?
- lutein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2023to May 2024
- 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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age of 8 to 16 years
- guardian-reported general good health
- guardian-reported 4 hours or more of digital screen time daily
Who cannot join
- Currently using a supplement containing lutein or zeaxanthin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Lutein Supplementation on Cognition and Vision in Healthy Children With Screen Time Exposure: A Randomized Controlled Trial
This is a single site, randomized, double-blind placebo controlled parallel arm study assessing the effects of 6 months lutein supplementation on cognitive and visual outcomes in healthy children exposed to excessive digital screen time.
Read the detailed description
Studies in humans and primates have also shown that appropriate daily intake of lutein provides protection to the eyes from blue light from screen time devices such as computers, televisions and phones. It has been well-documented that children are spending far over the recommended two hours screen time per day and excessive exposure to the high energy blue light associated with digital devices has been shown to cause both short-term and long-term visual damage as well as disruption to the sleep cycle. With a globally aging population, if this deficit is not addressed adequately early on in life then there will be substantial public health consequences. A recent study predicted that if individuals were to consume the recommended levels of lutein and zeaxanthin daily, there would be a seven percent reduced risk for age related eye disease and a potential savings of over five billion US dollars annually.
- Conditions
- Eye Fatigue, Diet, Healthy, Cognitive Change
- Being tested
- lutein, placebo
- Keywords
- lutein, carotenoids, blue light, screen time, digital stress
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
luteinDietary supplement
Also called FloraGLO Lutein
daily dose of 5 mg lutein
placeboDietary supplement
daily dose of 0 mg lutein
| Study group | Role | What they receive |
|---|---|---|
| Lutein | Experimental | 5 mg lutein gummy taken daily for 180 days Receives: Dietary Supplement: lutein |
| Placebo | Placebo comparator | 0 mg lutein gummy taken daily for 180 days Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Pigment Optical Density - heterochromatic flicker photometry
Level of macular carotenoids deposited in the eye measured using the psychophysical technique of heterochromatic flicker photometry (QuantifEye MPS-II Device). Minimum score of 0, no maximum. Average values range from 0.0 to 1.0. Higher numbers represent greater macular pigment.
Measured: 6 months
Macular Pigment Optical Density - haidinger's brushes
Level of macular carotenoids deposited in the eye measured using haidinger's brushes (Azul Optics MP-Eye Device). Minimum score of 0, maximum score of 10. Higher values represent greater macular pigment.
Measured: 6 months
Secondary outcomes (3)
Digital Eye strain change from baseline
Visual Fatigue Scale total score. Minimum score of 6, Maximum score of 24. Higher scores indicate higher levels of digital eye strain.
Benedetto, S., Drai-Zerbib, V., Pedrotti, M., Tissier, G., \& Baccino, T. (2013). E-readers and visual fatigue. PLoS One, 8(12)
Measured: 6 months
Sleep score change from baseline
Total score on the Cleveland Adolescent Sleepiness Questionnaire. Minimum score of 16, Maximum score of 80. Higher scores indicate greater sleepiness.
Spilsbury, J. C., et al. (2007). "The Cleveland adolescent sleepiness questionnaire: a new measure to assess excessive daytime sleepiness in adolescents." J Clin Sleep Med 3(6): 603-612.
Measured: 6 months
Verbal Fluency
Letter and semantic fluency using letter and animal naming. Total number of words names in a 60 second time frame. Higher score indicates greater verbal fluency
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start15 Jul 2023
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye FatigueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northcentral University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brenda Fonseca, Northcentral University
- Investigators
- Patrick McNamara, PhD, Study chair, Northcentral University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314647
- Sponsor's protocol ID
- NorthcentralU
- Status last verified
- Nov 2023
- First submitted
- 5 Mar 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lutein Supplementation on Cognition and Vision in Healthy Children With Screen Time Exposure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05314647
- Acronym / sponsor ID
- NorthcentralU
- Conditions
- Eye Fatigue, Diet, Healthy, Cognitive Change
- Keywords
- lutein, carotenoids, blue light, screen time, digital stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Northcentral UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 6 Apr 2022 (actual)
- 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 is a single site, randomized, double-blind placebo controlled parallel arm study assessing the effects of 6 months lutein supplementation on cognitive and visual outcomes in healthy children exposed to excessive digital screen time.
Detailed description
Studies in humans and primates have also shown that appropriate daily intake of lutein provides protection to the eyes from blue light from screen time devices such as computers, televisions and phones. It has been well-documented that children are spending far over the recommended two hours screen time per day and excessive exposure to the high energy blue light associated with digital devices has been shown to cause both short-term and long-term visual damage as well as disruption to the sleep cycle. With a globally aging population, if this deficit is not addressed adequately early on in life then there will be substantial public health consequences. A recent study predicted that if individuals were to consume the recommended levels of lutein and zeaxanthin daily, there would be a seven percent reduced risk for age related eye disease and a potential savings of over five billion US dollars annually.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Lutein | Experimental | Dietary Supplement: lutein5 mg lutein gummy taken daily for 180 days |
| Placebo | Placebo comparator | Dietary Supplement: placebo0 mg lutein gummy taken daily for 180 days |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age of 8 to 16 years
- guardian-reported general good health
- guardian-reported 4 hours or more of digital screen time daily
Key exclusion criteria (1 listed)
- Currently using a supplement containing lutein or zeaxanthin
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 |
|---|---|---|
| luteinAlso: FloraGLO Luteindaily dose of 5 mg lutein | Dietary supplement | Lutein |
| placebodaily dose of 0 mg lutein | Dietary supplement | Placebo |
Primary outcome
Macular Pigment Optical Density - heterochromatic flicker photometry
Time frame: 6 months
Level of macular carotenoids deposited in the eye measured using the psychophysical technique of heterochromatic flicker photometry (QuantifEye MPS-II Device). Minimum score of 0, no maximum. Average values range from 0.0 to 1.0. Higher numbers represent greater macular pigment.
Macular Pigment Optical Density - haidinger's brushes
Time frame: 6 months
Level of macular carotenoids deposited in the eye measured using haidinger's brushes (Azul Optics MP-Eye Device). Minimum score of 0, maximum score of 10. Higher values represent greater macular pigment.
3 secondary outcomes
Digital Eye strain change from baseline
Time frame: 6 months
Sleep score change from baseline
Time frame: 6 months
Verbal Fluency
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Patrick McNamara, PhD study chair
Northcentral University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lutein in people with Eye Fatigue and Diet, Healthy, run by Northcentral University 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Nov 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 - heterochromatic flicker photometry (time frame: 6 months). The study lists 2 primary outcomes in all. 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 30 Nov 2023.