Effects of Lutein Supplementation on Cognition and MPOD in Multiple Sc

Lutein and Multiple Sclerosis Experimental Study (LuMES)

Status unknownNot a drug-phase studyRelapsing MSNCT04843813

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Lutein

Placebo

  • Placebo

What it measured

Main measures

  • Macular Pigment Optical Density

    4 months (baseline vs. follow-up)

  • Attentional Accuracy

    4 months (baseline vs. follow-up)

    Thinking and memory

  • Attentional Reaction Time

    4 months (baseline vs. follow-up)

    Thinking and memory

  • Attentional Resource Allocation

    4 months (baseline vs. follow-up)

    Thinking and memory

  • Attentional Processing Speed

    4 months (baseline vs. follow-up)

    Myelin repairThinking and memory

Who could take part

Relapsing MS · 18 to 64 · EDSS 0 to 3.5

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Mar 2021

    2. Main results due

      Mar 2023

    3. Finished

      Mar 2023

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