Multiple Sclerosis Clinical Trial

Effects of Lutein Supplementation on Cognition and MPOD in Multiple Sclerosis Patients-

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 supplementation on biological markers of lutein status and cognitive function among persons with MS.

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Full 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.

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Eligibility 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

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

60

Study ID:

NCT04843813

Recruitment Status:

Recruiting

Sponsor:

University of Illinois at Urbana-Champaign

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University of Illinois at Urbana-Champaign
Urbana Illinois, 61801, United States More Info
Naiman A Khan, PhD, RD
Contact
[email protected]
Naiman A Khan, PhD, RD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

60

Study ID:

NCT04843813

Recruitment Status:

Recruiting

Sponsor:


University of Illinois at Urbana-Champaign

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