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

Primary Purpose

Multiple Sclerosis

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lutein

Placebo

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Cognitive Function, Lutein

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

University of Illinois at Urbana-ChampaignRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lutein

Safflower Oil

Arm Description

Outcomes

Primary Outcome Measures

Macular Pigment Optical Density

Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer

Attentional Accuracy

Changes in accuracy (%) between groups using a computerized flanker task

Attentional Reaction Time

Changes in reaction time (ms) between groups using a computerized flanker task

Attentional Resource Allocation

Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task

Attentional Processing Speed

Changes in P3 event related potential latency (ms) between groups using a computerized flanker task

Secondary Outcome Measures

Full Information

NCT ID

NCT04843813

First Posted

April 7, 2021

Last Updated

April 12, 2021

Sponsor

University of Illinois at Urbana-Champaign

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04843813

Brief Title

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

Acronym

LuMES

Official Title

Lutein and Multiple Sclerosis Experimental Study (LuMES)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 26, 2021 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Illinois at Urbana-Champaign

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Multiple Sclerosis, Cognitive Function, Lutein

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lutein

Arm Type

Experimental

Arm Title

Safflower Oil

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Lutein

Intervention Description

Participants will consume daily soft gels containing the lutein supplement.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Participants will consume daily soft gels containing the safflower oil.

Primary Outcome Measure Information:

Title

Macular Pigment Optical Density

Description

Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer

Time Frame