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

Multiple Sclerosis Clinical Trial

— LuMES  

Official title:

Lutein and Multiple Sclerosis Experimental Study (LuMES)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04843813
• Other study ID #: 2001-2
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2021
• Est. completion date: March 2023

Study information

• Verified date: April 2021
• Source: University of Illinois at Urbana-Champaign
• Contact: Naiman Khan, PhD, RD
• Phone: 217-300-2197
• Email: nakhan2[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Dietary Supplement:
• Lutein
Participants will consume daily soft gels containing the lutein supplement.
• Placebo
Participants will consume daily soft gels containing the safflower oil.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (3)

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)

Country where clinical trial is conducted

United States, 

Outcome

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)