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

April 12, 2021 updated by: Naiman Khan, University of Illinois at Urbana-Champaign

Lutein and Multiple Sclerosis Experimental Study (LuMES)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • University of Illinois at Urbana-Champaign
        • Principal Investigator:
          • Naiman A Khan, PhD, RD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 9, 2021

First Posted (Actual)

April 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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