Multiple SclerosisLuMESNCT04843813
Effects of Lutein Supplementation on Cognition and MPOD in Multiple Sclerosis Patients-
A study testing Lutein in people with Multiple Sclerosis, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The central hypothesis is that lutein supplementation will improve MPOD and cognition. Accordingly, the specific aims are to 1) to determine the process feasibility associated with participating in 4-month lutein supplementation trial; and 2) to investigate the scientific feasibility of 4-month daily lutein… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Lutein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2021to Mar 2023
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-64.9 years
- Self-reported relapsing-remitting MS (RRMS) diagnosis
- Expanded Disability Status Scale (EDSS) score between 0-3.5
- Macular Pigment Optical Density at baseline (MPOD ≤0.35)
- Score ≤55 during the Symbol Digit Modalities Test (SDMT)
- 20/20 or corrected vision
Show all 9Show fewer
- No presence of color blindness
- No history of age-related macular degeneration
- No history of epileptic seizures
Who cannot join
- Under 18 years or over 64.9 years
- MS diagnosis other than RRMS
- Pregnancy
- Uncorrected vision
- Presence of color blindness
- PDDS score of 7 or more
- Prior diagnosis of age-related macular degeneration
- History of epileptic seizures
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
Naiman A Khan, PhD, RD, nakhan2@illinois.edu
Naiman A Khan, PhD, RD
About this study
Official title: Lutein and Multiple Sclerosis Experimental Study (LuMES)
The central hypothesis is that lutein supplementation will improve MPOD and cognition. Accordingly, the specific aims are to 1) to determine the process feasibility associated with participating in 4-month lutein supplementation trial; and 2) to investigate the scientific feasibility of 4-month daily lutein supplementation on biological markers of lutein status and cognitive function among persons with MS.
Read the detailed description
A two-group parallel design will be employed whereby participants will be randomly assigned to one of 2 groups. The supplementation doses 20mg/d (Group 1), and placebo (Group 2) will be consumed daily by the participant for a 4-month period. Pre-test and follow-up measures of lutein status and cognitive function will be assessed at baseline and at 4-month follow-up via laboratory visits.
- Conditions
- Multiple Sclerosis
- Being tested
- Lutein, Placebo
- Keywords
- Multiple Sclerosis, Cognitive Function, Lutein
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuteinDietary supplement
Participants will consume daily soft gels containing the lutein supplement.
PlaceboDietary supplement
Participants will consume daily soft gels containing the safflower oil.
| Study group | Role | What they receive |
|---|---|---|
| Lutein | Experimental | Not described Receives: Dietary Supplement: Lutein |
| Safflower Oil | Placebo comparator | Not described 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
Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer
Measured: 4 months (baseline vs. follow-up)
Attentional Accuracy
Changes in accuracy (%) between groups using a computerized flanker task
Measured: 4 months (baseline vs. follow-up)
Attentional Reaction Time
Changes in reaction time (ms) between groups using a computerized flanker task
Measured: 4 months (baseline vs. follow-up)
Attentional Resource Allocation
Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task
Measured: 4 months (baseline vs. follow-up)
Attentional Processing Speed
Changes in P3 event related potential latency (ms) between groups using a computerized flanker task
Measured: 4 months (baseline vs. follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start26 Mar 2021
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 2-group parallel design will be employed to collect feasibility data on daily lutein supplementation over 4 months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Naiman Khan, University of Illinois at Urbana-Champaign
- Investigators
- Naiman Khan, PhD, Principal investigator, University of Illinois Urbana Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843813
- Sponsor's protocol ID
- 2001-2
- Acronym
- LuMES
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martell SG, Kim J, Cannavale CN, Mehta TD, Erdman JW Jr, Adamson B, Motl RW, Khan NA. Randomized, Placebo-Controlled, Single-Blind Study of Lutein Supplementation on Carotenoid Status and Cognition in Persons with Multiple Sclerosis. J Nutr. 2023 Aug;153(8):2298-2311. doi: 10.1016/j.tjnut.2023.06.027. Epub 2023 Jun 25.
PubMed 37364683
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lutein and Multiple Sclerosis Experimental Study (LuMES)
- ClinicalTrials.gov ID
- NCT04843813
- Acronym / sponsor ID
- LuMES / 2001-2
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Cognitive Function, Lutein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, National Institutes of Health (NIH)
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 14 Apr 2021 (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 central hypothesis is that lutein supplementation will improve MPOD and cognition. Accordingly, the specific aims are to 1) to determine the process feasibility associated with participating in 4-month lutein supplementation trial; and 2) to investigate the scientific feasibility of 4-month daily lutein supplementation on biological markers of lutein status and cognitive function among persons with MS.
Detailed description
A two-group parallel design will be employed whereby participants will be randomly assigned to one of 2 groups. The supplementation doses 20mg/d (Group 1), and placebo (Group 2) will be consumed daily by the participant for a 4-month period. Pre-test and follow-up measures of lutein status and cognitive function will be assessed at baseline and at 4-month follow-up via laboratory visits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A 2-group parallel design will be employed to collect feasibility data on daily lutein supplementation over 4 months.
| Arm | Type | Receives |
|---|---|---|
| Lutein | Experimental | Dietary Supplement: Lutein |
| Safflower Oil | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 18-64.9 years
- Self-reported relapsing-remitting MS (RRMS) diagnosis
- Expanded Disability Status Scale (EDSS) score between 0-3.5
- Macular Pigment Optical Density at baseline (MPOD ≤0.35)
- Score ≤55 during the Symbol Digit Modalities Test (SDMT)
Key exclusion criteria (8 listed)
- Under 18 years or over 64.9 years
- MS diagnosis other than RRMS
- Pregnancy
- Uncorrected vision
- Presence of color blindness
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 |
|---|---|---|
| LuteinParticipants will consume daily soft gels containing the lutein supplement. | Dietary supplement | Lutein |
| PlaceboParticipants will consume daily soft gels containing the safflower oil. | Dietary supplement | Safflower Oil |
Primary outcome
Macular Pigment Optical Density
Time frame: 4 months (baseline vs. follow-up)
Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer
Attentional Accuracy
Time frame: 4 months (baseline vs. follow-up)
Changes in accuracy (%) between groups using a computerized flanker task
Attentional Reaction Time
Time frame: 4 months (baseline vs. follow-up)
Changes in reaction time (ms) between groups using a computerized flanker task
Attentional Resource Allocation
Time frame: 4 months (baseline vs. follow-up)
Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task
Attentional Processing Speed
Time frame: 4 months (baseline vs. follow-up)
Changes in P3 event related potential latency (ms) between groups using a computerized flanker task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Derived from this study: PubMed 37364683Martell SG, Kim J, Cannavale CN, Mehta TD, Erdman JW Jr, Adamson B, Motl RW, Khan NA. Randomized, Placebo-Controlled, Single-Blind Study of Lutein Supplementation on Carotenoid Status and Cognition in Persons with Multiple Sclerosis. J Nutr. 2023 Aug;153(8):2298-2311. doi: 10.1016/j.tjnut.2023.06.027. Epub 2023 Jun 25.
- 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.
Naiman Khan, PhD principal investigator
University of Illinois Urbana Champaign
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 Multiple Sclerosis, 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 9 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: status not confirmed, as of the sponsor's last update on 15 Apr 2021. 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?
Contact Naiman Khan, PhD, RD (217-300-2197, nakhan2@illinois.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 (time frame: 4 months (baseline vs. follow-up)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04843813, which also lists 1 linked publication.
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 15 Apr 2021.