VisionEyeCARENCT06848101
Eye and Carotenoid Augmentation Research and Evaluation (EyeCARE)
A study testing Carotenoid Group in people with Vision and Eye Health, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The primary study outcomes are to investigate the effects of 4-month daily carotenoid complex supplementation on carotenoid status in the macula and skin and visual fatigue among adults 20-45 years of age. Secondary outcomes will examine the supplementation effects on cognitive function. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vision, Eye Health
- What is being tested?
- Carotenoid Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 14 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- not pregnant
- not breastfeeding
- absence of hypertension
- absence of diabetes
- absence of cerebrovascular disease
- absence of cardiovascular disease
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- absence of liver disease
- absence of kidney disease
- absence of gastrointestinal disease
- absence of age-related macular degeneration
- no allergy to carotenoids
- 20/20 or corrected vision
- MPOD less than or equal to 0.60
- Age between 20-45 years
Who cannot join
- pregnant
- breastfeeding
- presence of hypertension
- presence of diabetes
- presence of cerebrovascular disease
- presence of cardiovascular disease
Show all 14Show fewer
- presence of liver disease
- presence of kidney disease
- presence of gastrointestinal disease
- presence of age-related macular degeneration
- allergy to carotenoids
- not 20/20 or uncorrected vision
- MPOD greater than 0.60
- Younger than 20 years or older than 45 years
Trial locations and contacts
1 site in 1 country.
About this study
The primary study outcomes are to investigate the effects of 4-month daily carotenoid complex supplementation on carotenoid status in the macula and skin and visual fatigue among adults 20-45 years of age. Secondary outcomes will examine the supplementation effects on cognitive function.
Read the detailed description
Lutein and zeaxanthin are carotenoids or plant-based pigments that accumulate in various human tissues including the eye, skin, adipose/fat, and the brain where they play important roles as antioxidants and light filters. Previous correlational work has shown that lutein and zeaxanthin intake is associated with multiple markers of health including visual and cognitive outcomes. However, experimental or intervention research examining the effects of lutein and zeaxanthin supplementation on the accumulation of these carotenoids in the eye and skin and implications for visual and cognitive function is still emerging. Additionally, virtually all the previous research has relied on single nutrient supplementation (e.g., only lutein or zeaxanthin) resulting in limited knowledge of the benefits of providing these carotenoids with other possibly healthful nutrients (e.g., astaxanthin, vitamin E). Accordingly, this project will test the effects of lutein and zeaxanthin supplementation provided in a complex with other antioxidants and nutrients on outcomes of nutritional status in the eye and skin as well as visual and cognitive health. The study aims will be addressed using a double-blind randomized controlled trial design. Adults 20-45 years of age will be asked to participate in a daily 4-month double-blind randomized controlled clinical trial. Treatment group (N=20) participants will be asked to consume 2 daily softgels with a daily total containing 20mg free lutein (10mg/softgel), 4 mg free zeaxanthin (2mg/softgel), 40mg maqui berry extract (20mg/softgel), 6 mg astaxanthin (3 mg/softgel), 80mg bilberry extract (40mg/softgel), flaxseed oil (150mg/softgel), and vitamin E (5IU/softgel). Participants will be asked to consume the supplements with a meal of their choosing. Control group participants will be asked to consume similar-looking placebo softgels over the same period.
- Conditions
- Vision, Eye Health
- Being tested
- Carotenoid Group, Control (placebo) group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotenoid GroupDietary supplement
Treatment will contain 20mg free lutein (10mg/softgel), 4 mg free zeaxanthin (2mg/softgel), 40mg maqui berry extract (20mg/softgel), 6 mg astaxanthin (3 mg/softgel), 80mg bilberry extract (40mg/softgel), flaxseed oil (150mg/softgel), and vitamin E (5IU/softgel)
Control (placebo) groupDietary supplement
Flaxseed Oil (330mg)
| Study group | Role | What they receive |
|---|---|---|
| Carotenoid Complex Supplement | Experimental | 20mg free lutein (10mg/softgel), 4 mg free zeaxanthin (2mg/softgel), 40mg maqui berry extract (20mg/softgel), 6 mg astaxanthin (3 mg/softgel), 80mg bilberry extract (40mg/softgel), flaxseed oil (150mg/softgel), and vitamin E (5IU/softgel) Receives: Dietary Supplement: Carotenoid Group |
| Control | Placebo comparator | flaxseed oil (330mg) Receives: Dietary Supplement: Control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Pigment Optical Density
Macular carotenoids assessed using heterochromatic flicker photometry
Measured: From enrollment to end of treatment at 4 months
Secondary outcomes (2)
Skin carotenoids
Carotenoids in skin assessed using skin reflection spectroscopy
Measured: From enrollment to end of treatment at 4 months
Visual Fatigue
Visual fatigue as assessed by the Computer Vision Syndrome Questionnaire
Measured: From enrollment to end of treatment at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start15 Mar 2024
- Primary completion14 Mar 2025 (estimated)
- Study completion14 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VisionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Daiken Biomedical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848101
- Sponsor's protocol ID
- IRB23-0196
- Acronym
- EyeCARE
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye and Carotenoid Augmentation Research and Evaluation (EyeCARE)
- ClinicalTrials.gov ID
- NCT06848101
- Acronym / sponsor ID
- EyeCARE / IRB23-0196
- Conditions
- Vision, Eye Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Daiken Biomedical Co., Ltd.
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 14 Mar 2025 (estimated)
- Study completion
- 14 Mar 2025 (estimated)
- First posted
- 26 Feb 2025 (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.
The primary study outcomes are to investigate the effects of 4-month daily carotenoid complex supplementation on carotenoid status in the macula and skin and visual fatigue among adults 20-45 years of age. Secondary outcomes will examine the supplementation effects on cognitive function.
Detailed description
Lutein and zeaxanthin are carotenoids or plant-based pigments that accumulate in various human tissues including the eye, skin, adipose/fat, and the brain where they play important roles as antioxidants and light filters. Previous correlational work has shown that lutein and zeaxanthin intake is associated with multiple markers of health including visual and cognitive outcomes. However, experimental or intervention research examining the effects of lutein and zeaxanthin supplementation on the accumulation of these carotenoids in the eye and skin and implications for visual and cognitive function is still emerging. Additionally, virtually all the previous research has relied on single nutrient supplementation (e.g., only lutein or zeaxanthin) resulting in limited knowledge of the benefits of providing these carotenoids with other possibly healthful nutrients (e.g., astaxanthin, vitamin E). Accordingly, this project will test the effects of lutein and zeaxanthin supplementation provided in a complex with other antioxidants and nutrients on outcomes of nutritional status in the eye and skin as well as visual and cognitive health. The study aims will be addressed using a double-blind randomized controlled trial design. Adults 20-45 years of age will be asked to participate in a daily 4-month double-blind randomized controlled clinical trial. Treatment group (N=20) participants will be asked to consume 2 daily softgels with a daily total containing 20mg free lutein (10mg/softgel), 4 mg free zeaxanthin (2mg/softgel), 40mg maqui berry extract (20mg/softgel), 6 mg astaxanthin (3 mg/softgel), 80mg bilberry extract (40mg/softgel), flaxseed oil (150mg/softgel), and vitamin E (5IU/softgel). Participants will be asked to consume the supplements with a meal of their choosing. Control group participants will be asked to consume similar-looking placebo softgels over the same period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotenoid Complex Supplement | Experimental | Dietary Supplement: Carotenoid Group20mg free lutein (10mg/softgel), 4 mg free zeaxanthin (2mg/softgel), 40mg maqui berry extract (20mg/softgel), 6 mg astaxanthin (3 mg/softgel), 80mg bilberry extract (40mg/softgel), flaxseed oil (150mg/softgel), and vitamin E (5IU/softgel) |
| Control | Placebo comparator | Dietary Supplement: Control (placebo) groupflaxseed oil (330mg) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- not pregnant
- not breastfeeding
- absence of hypertension
- absence of diabetes
- absence of cerebrovascular disease
Key exclusion criteria (14 listed)
- pregnant
- breastfeeding
- presence of hypertension
- presence of diabetes
- presence of cerebrovascular disease
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 |
|---|---|---|
| Carotenoid GroupTreatment will contain 20mg free lutein (10mg/softgel), 4 mg free zeaxanthin (2mg/softgel), 40mg maqui berry extract (20mg/softgel), 6 mg astaxanthin (3 mg/softgel), 80mg bilberry extract (40mg/softgel), flaxseed oil (150mg/softgel), and vitamin E (5IU/softgel) | Dietary supplement | Carotenoid Complex Supplement |
| Control (placebo) groupFlaxseed Oil (330mg) | Dietary supplement | Control |
Primary outcome
Macular Pigment Optical Density
Time frame: From enrollment to end of treatment at 4 months
Macular carotenoids assessed using heterochromatic flicker photometry
2 secondary outcomes
Skin carotenoids
Time frame: From enrollment to end of treatment at 4 months
Visual Fatigue
Time frame: From enrollment to end of treatment at 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotenoid Group in people with Vision and Eye Health, run by University of Illinois at Urbana-Champaign 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 14 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 26 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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: From enrollment to end of treatment at 4 months). 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 26 Feb 2025.