Cognitive PerformanceNCT06489873
Lutein, Zeaxathin, and Fish Oil Supplementation
A study testing Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF) in people with Cognitive Performance and Age-Related Macular Degeneration, run by Texas A&M University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn the impact of lutein, zeaxanthin, and fish oil (LZF) supplementation in healthy adults. The main question it aims to answer is: Will supplementation with LZF improve macular pigment optical density (MPOD), cognitive performance and bone mass compared to controls after six… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance, Age-Related Macular Degeneration, Bone Loss
- What is being tested?
- Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2024to 1 May 2026
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- <.43 MPOD, a self-reported best-corrected vision of 20/40 or better in each eye, a BMI range of 18.5-30, and meets the inclusion criteria on the preliminary participant questionnaire.
Who cannot join
- allergic to lutein, zeaxanthin, or fish oil, taking supplements with >6 mg lutein and/or >2 mg zeaxanthin for more than two months before study starts, MPOD between >.43, self-reported condition of vertigo, diabetic retinopathy, retinitis pigmentosa, optic neuropathy, retinal vascular occlusions, strabismus, autoimmune disorders related to visual health, currently pregnant or trying to become pregnant, history of concussion, vegan (due to gelatin in the placebo), and/or taking neuroactive medications, such as Ritalin, Adderall, antidepressants, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Gilchrist Building
College Station, Texas, 77843
Steven E. Riechman, PhD, 979-862-3213, sriechman@tamu.edu
Karen M. Beathard, PhD, 979-220-2281, karen-beathard@tamu.edu
About this study
Official title: The Role of Lutein, Zeaxanthin, and Fish Oil on Cognitive Function and Bone Health in Healthy Adults
The goal of this clinical trial is to learn the impact of lutein, zeaxanthin, and fish oil (LZF) supplementation in healthy adults.
The main question it aims to answer is: Will supplementation with LZF improve macular pigment optical density (MPOD), cognitive performance and bone mass compared to controls after six months?
Subjects with an MPOD <.43 will significantly improve MPOD after 6-months of LZF supplementation.
Consuming a LZFO supplement for 6-months will improve visual cognitive performance. Consuming a LZFO supplement for 6-months will improve bone density.
Participants will be asked to take either a LZF supplement or placebo daily for 6 months.
Read the detailed description
Macular degeneration, cognitive decline, and osteoporosis often occur with aging. Lutein, zeaxanthin, and fish oil (LZF) have been shown to have improvements in these areas. This 6-month double-blind randomized controlled trial will study the impact of LZF on cognitive performance, macular pigment optical density (MPOD), and bone health in healthy adults ages 18-45 with a MPOD <.43. We seek to create a precision nutrition model reducing macular degeneration, cognition, and bone health that includes non-invasive screening for high-risk carotenoid deficiencies (MPOD, dietary intake) and individual response to LZF supplementation.
Healthy adults ages 18-45 years with MPOD <.43 will be randomly assigned to take a LZF supplement with 7 mg lutein, 14 mg zeaxanthin, and 245 mg fish oil or a placebo daily for six months. They will have baseline and ending measures of fasting blood draw, MPOD, bone health using a DXA, and visual cognitive performance using Neurotracker software.
- Being tested
- Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF), Placebo Comparator
- Keywords
- Lutein, Zeaxanthin, Fish Oil, Supplement, Macular Pigment, Macular Pigment Optical Density, Cognition, Age-related Macular Degeneration, Cognitive Performance
- Medical subject headings
- Macular Degeneration, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF)Dietary supplement
Each participant will be assigned to t a LZF supplement daily for six months
Placebo ComparatorDietary supplement
Each participant will be assigned to take a placebo supplement daily for six months
| Study group | Role | What they receive |
|---|---|---|
| LZF Supplement | Active comparator | Participants will take one LZF supplement daily for six months. Receives: Dietary Supplement: Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF) |
| Placebo | Placebo comparator | Participants will take on placebo supplement daily for six months. Receives: Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Pigment Optical Density (MPOD)
The MPS II will be used to measure MPOD
Measured: MPOD will be measured at baseline, 3 months after the start of the study, and at the final 6 month visit, which will be the completion of the study.
Cognitive Performance
Neurotracker 3-dimensional software will be used to measure cognitive performance. Each cognitive performance session will include 15 6-second tests that will establish a speed threshold.
Measured: Cognitive performance will be measured at the three baseline appointments, the three appointments at 3 months, and the 3 appointments at 6 months after the start of the study, which will be the completion of the study
Bone Density
The Horizon™ DXA System will be used for rapid, dual-energy bone density measurements in a single-sweep.
Measured: Bone density will be measured at baseline and at the final 6 month visit, which will be the completion of the study.
Secondary outcomes (1)
Lutein and Zeaxanthin Serum Levels
Serum will be drawn and analyzed for lutein and zeaxanthin content
Measured: Serum lutein and zeaxanthin will be measured at baseline and at the final 6 month visit, which will be the completion of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start7 Feb 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to an LZF or placebo supplement group and asked to take the assigned supplement daily for six months.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Allen Foundation Inc.
- Responsible party
- Principal investigator, Karen Beathard, Texas A&M University
- Investigators
- Karen M Beathard, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489873
- Sponsor's protocol ID
- 2024-0035
- Status last verified
- Sep 2025
- First submitted
- 28 Jun 2024
- Last updated
- 30 Sep 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 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Lutein, Zeaxanthin, and Fish Oil on Cognitive Function and Bone Health in Healthy Adults
- ClinicalTrials.gov ID
- NCT06489873
- Acronym / sponsor ID
- 2024-0035
- Keywords
- Lutein, Zeaxanthin, Fish Oil, Supplement, Macular Pigment, Macular Pigment Optical Density, Cognition, Age-related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Allen Foundation Inc.
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 8 Jul 2024 (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 goal of this clinical trial is to learn the impact of lutein, zeaxanthin, and fish oil (LZF) supplementation in healthy adults.
The main question it aims to answer is: Will supplementation with LZF improve macular pigment optical density (MPOD), cognitive performance and bone mass compared to controls after six months?
Subjects with an MPOD <.43 will significantly improve MPOD after 6-months of LZF supplementation.
Consuming a LZFO supplement for 6-months will improve visual cognitive performance. Consuming a LZFO supplement for 6-months will improve bone density.
Participants will be asked to take either a LZF supplement or placebo daily for 6 months.
Detailed description
Macular degeneration, cognitive decline, and osteoporosis often occur with aging. Lutein, zeaxanthin, and fish oil (LZF) have been shown to have improvements in these areas. This 6-month double-blind randomized controlled trial will study the impact of LZF on cognitive performance, macular pigment optical density (MPOD), and bone health in healthy adults ages 18-45 with a MPOD <.43. We seek to create a precision nutrition model reducing macular degeneration, cognition, and bone health that includes non-invasive screening for high-risk carotenoid deficiencies (MPOD, dietary intake) and individual response to LZF supplementation.
Healthy adults ages 18-45 years with MPOD <.43 will be randomly assigned to take a LZF supplement with 7 mg lutein, 14 mg zeaxanthin, and 245 mg fish oil or a placebo daily for six months. They will have baseline and ending measures of fasting blood draw, MPOD, bone health using a DXA, and visual cognitive performance using Neurotracker software.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to an LZF or placebo supplement group and asked to take the assigned supplement daily for six months.
| Arm | Type | Receives |
|---|---|---|
| LZF Supplement | Active comparator | Dietary Supplement: Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF)Participants will take one LZF supplement daily for six months. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo ComparatorParticipants will take on placebo supplement daily for six months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- <.43 MPOD, a self-reported best-corrected vision of 20/40 or better in each eye, a BMI range of 18.5-30, and meets the inclusion criteria on the preliminary participant questionnaire.
Key exclusion criteria (1 listed)
- allergic to lutein, zeaxanthin, or fish oil, taking supplements with >6 mg lutein and/or >2 mg zeaxanthin for more than two months before study starts, MPOD between >.43, self-reported condition of vertigo, diabetic retinopathy, retinitis pigmentosa, optic neuropathy, retinal vascular occlusions, strabismus, autoimmune disorders related to visual health, currently pregnant or trying to become pregnant, history of concussion, vegan (due to gelatin in the placebo), and/or taking neuroactive medications, such as Ritalin, Adderall, antidepressants, etc.
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 |
|---|---|---|
| Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF)Each participant will be assigned to t a LZF supplement daily for six months | Dietary supplement | LZF Supplement |
| Placebo ComparatorEach participant will be assigned to take a placebo supplement daily for six months | Dietary supplement | Placebo |
Primary outcome
Macular Pigment Optical Density (MPOD)
Time frame: MPOD will be measured at baseline, 3 months after the start of the study, and at the final 6 month visit, which will be the completion of the study.
The MPS II will be used to measure MPOD
Cognitive Performance
Time frame: Cognitive performance will be measured at the three baseline appointments, the three appointments at 3 months, and the 3 appointments at 6 months after the start of the study, which will be the completion of the study
Neurotracker 3-dimensional software will be used to measure cognitive performance. Each cognitive performance session will include 15 6-second tests that will establish a speed threshold.
Bone Density
Time frame: Bone density will be measured at baseline and at the final 6 month visit, which will be the completion of the study.
The Horizon™ DXA System will be used for rapid, dual-energy bone density measurements in a single-sweep.
1 secondary outcome
Lutein and Zeaxanthin Serum Levels
Time frame: Serum lutein and zeaxanthin will be measured at baseline and at the final 6 month visit, which will be the completion of the study.
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 30 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Cognitive Performance
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
Effects of Red Panax Ginseng Supplementation on Cognitive Performance and Emotional Well-Being in Young Healthy Adults
Mental Acuity
RecruitingPhase 4
Improving Morning Strength and Cognitive Performance Using Caffeine or Whole-body Vibration.
Vibration Therapy, Caffeine
Not yet recruiting
The Effects of Ischemic Conditioning in Individuals With Parkinson's Disease
Parkinson Disease
Recruiting
The Effect of Water Temperature on Heart Rate Variability and Cognition
Mental Acuity
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.
Karen M Beathard, PhD principal investigator
Texas A&M 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 Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF) in people with Cognitive Performance and Age-Related Macular Degeneration, run by Texas A&M 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 1 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: looking for participants now, as of the sponsor's last update on 30 Sep 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?
Contact Karen M Beathard, PhD (979-220-2281, karen-beathard@tamu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular Pigment Optical Density (MPOD) (time frame: MPOD will be measured at baseline, 3 months after the start of the study, and at the final 6 month visit, which will be the completion of the study.). The study lists 3 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 Sep 2025.