Multiple Sclerosis Clinical Trial
— LuMESOfficial title:
Lutein and Multiple Sclerosis Experimental Study (LuMES)
NCT number | NCT04843813 |
Other study ID # | 2001-2 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 26, 2021 |
Est. completion date | March 2023 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - 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 - No presence of color blindness - No history of age-related macular degeneration - No history of epileptic seizures Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Urbana-Champaign | Urbana | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Urbana-Champaign | Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, National Institutes of Health Rehabilitation Research Resource to Enhance Clinical Trials (REACT) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Macular Pigment Optical Density | Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer | 4 months (baseline vs. follow-up) | |
Primary | Attentional Accuracy | Changes in accuracy (%) between groups using a computerized flanker task | 4 months (baseline vs. follow-up) | |
Primary | Attentional Reaction Time | Changes in reaction time (ms) between groups using a computerized flanker task | 4 months (baseline vs. follow-up) | |
Primary | Attentional Resource Allocation | Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task | 4 months (baseline vs. follow-up) | |
Primary | Attentional Processing Speed | Changes in P3 event related potential latency (ms) between groups using a computerized flanker task | 4 months (baseline vs. follow-up) |
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