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

Sponsor

University of Illinois at Urbana-Champaign (Other)

Overall Status

Recruiting

CT.gov ID

NCT04843813

Collaborator

Division of Nutritional Sciences, University of Illinois at Urbana-Champaign (Other), National Institutes of Health Rehabilitation Research Resource to Enhance Clinical Trials (REACT) (Other)

Enrollment

Location

Arms

23.2

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Dietary Supplement: Lutein Dietary Supplement: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A 2-group parallel design will be employed to collect feasibility data on daily lutein supplementation over 4 months.A 2-group parallel design will be employed to collect feasibility data on daily lutein supplementation over 4 months.

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Lutein and Multiple Sclerosis Experimental Study (LuMES)

Actual Study Start Date :

Mar 26, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lutein	Dietary Supplement: Lutein Participants will consume daily soft gels containing the lutein supplement.
Placebo Comparator: Safflower Oil	Dietary Supplement: Placebo Participants will consume daily soft gels containing the safflower oil.

Arm

Intervention/Treatment

Experimental: Lutein

Dietary Supplement: Lutein

Participants will consume daily soft gels containing the lutein supplement.

Placebo Comparator: Safflower Oil

Dietary Supplement: Placebo

Participants will consume daily soft gels containing the safflower oil.

Outcome Measures

Primary Outcome Measures

Macular Pigment Optical Density [4 months (baseline vs. follow-up)]
Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer
Attentional Accuracy [4 months (baseline vs. follow-up)]
Changes in accuracy (%) between groups using a computerized flanker task
Attentional Reaction Time [4 months (baseline vs. follow-up)]
Changes in reaction time (ms) between groups using a computerized flanker task
Attentional Resource Allocation [4 months (baseline vs. follow-up)]
Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task
Attentional Processing Speed [4 months (baseline vs. follow-up)]
Changes in P3 event related potential latency (ms) between groups using a computerized flanker task

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Urbana-Champaign	Urbana	Illinois	United States	61801

Sponsors and Collaborators

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)

Investigators

Principal Investigator: Naiman Khan, PhD, University of Illinois Urbana Champaign

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Naiman Khan, Assistant Professor, University of Illinois at Urbana-Champaign

ClinicalTrials.gov Identifier:

NCT04843813

Other Study ID Numbers:

2001-2

First Posted:

Apr 14, 2021

Last Update Posted:

Apr 15, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Naiman Khan, Assistant Professor, University of Illinois at Urbana-Champaign

Multiple Sclerosis

Cognitive Function

Lutein

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Study Results

No Results Posted as of Apr 15, 2021