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

Overview

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.

Full Title of Study: “Lutein and Multiple Sclerosis Experimental Study (LuMES)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 2023

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Lutein
  • Placebo Comparator: Safflower Oil

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Attentional Accuracy
    • Time Frame: 4 months (baseline vs. follow-up)
    • Changes in accuracy (%) between groups using a computerized flanker task
  • Attentional Reaction Time
    • Time Frame: 4 months (baseline vs. follow-up)
    • Changes in reaction time (ms) between groups using a computerized flanker task
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Illinois at Urbana-Champaign
  • Collaborator
    • Division of Nutritional Sciences, University of Illinois at Urbana-Champaign
  • Provider of Information About this Clinical Study
    • Principal Investigator: Naiman Khan, Assistant Professor – University of Illinois at Urbana-Champaign
  • Overall Official(s)
    • Naiman Khan, PhD, Principal Investigator, University of Illinois Urbana Champaign
  • Overall Contact(s)
    • Naiman Khan, PhD, RD, 217-300-2197, nakhan2@illinois.edu

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