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

University of Illinois at Urbana-Champaign

Status: Unknown

Conditions: Multiple Sclerosis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lutein

Study type: Interventional

Funder types: Other

Identifiers

NCT04843813

2001-2

Details and patient eligibility

About

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.

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Lutein

Experimental group

Treatment:

Dietary Supplement: Lutein

Safflower Oil

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo