NCT04843813

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

Lutein and Multiple Sclerosis Experimental Study (LuMES)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Illinois at Urbana-Champaign · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lutein	Participants will consume daily soft gels containing the lutein supplement.
DIETARY_SUPPLEMENT	Placebo	Participants will consume daily soft gels containing the safflower oil.

Timeline

• Start date: 2021-03-26
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2021-04-14
• Last updated: 2021-04-15

Locations

1 site across 1 country: United States