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

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ClinicalTrials.gov Identifier: NCT04843813
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : April 15, 2021
Sponsor:
Collaborators:
Division of Nutritional Sciences, University of Illinois at Urbana-Champaign
National Institutes of Health Rehabilitation Research Resource to Enhance Clinical Trials (REACT)
Information provided by (Responsible Party):
Naiman Khan, University of Illinois at Urbana-Champaign

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Lutein and Multiple Sclerosis Experimental Study (LuMES)
Actual Study Start Date : March 26, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

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.




Primary Outcome Measures :
  1. 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

  2. Attentional Accuracy [ Time Frame: 4 months (baseline vs. follow-up) ]
    Changes in accuracy (%) between groups using a computerized flanker task

  3. Attentional Reaction Time [ Time Frame: 4 months (baseline vs. follow-up) ]
    Changes in reaction time (ms) between groups using a computerized flanker task

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843813


Contacts
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Contact: Naiman Khan, PhD, RD 217-300-2197 nakhan2@illinois.edu

Locations
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United States, Illinois
University of Illinois at Urbana-Champaign Recruiting
Urbana, Illinois, United States, 61801
Contact: Naiman A Khan, PhD, RD       nakhan2@illinois.edu   
Principal Investigator: Naiman A Khan, PhD, RD         
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
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Principal Investigator: Naiman Khan, PhD University of Illinois Urbana Champaign
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Responsible Party: Naiman Khan, Assistant Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT04843813    
Other Study ID Numbers: 2001-2
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Naiman Khan, University of Illinois at Urbana-Champaign:
Multiple Sclerosis
Cognitive Function
Lutein
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases