Recruiting

Lutein

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT04843813

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Lutein

Placebo

Study Details

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.

Conditions

Multiple Sclerosis

Study ID

NCT04843813

Start date

Mar 26, 2021

Status verified date

Apr, 2021

Completion date

Mar, 2023

Anticipated

Primary completion date

Mar, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Lutein

placebo comparator: Safflower Oil

Interventions

Lutein

Participants will consume daily soft gels containing the lutein supplement.

Placebo

Participants will consume daily soft gels containing the safflower oil.

Primary outcome measure

  • Macular Pigment Optical Density [ Time Frame: 4 months (baseline vs. follow-up) ]
  • Attentional Accuracy [ Time Frame: 4 months (baseline vs. follow-up) ]
  • Attentional Reaction Time [ Time Frame: 4 months (baseline vs. follow-up) ]
  • Attentional Resource Allocation [ Time Frame: 4 months (baseline vs. follow-up) ]
  • Attentional Processing Speed [ Time Frame: 4 months (baseline vs. follow-up) ]

Central Contacts and Locations

Central contacts

Naiman Khan, PhD, RD

217-300-2197nakhan2@illinois.edu

Locations

University of Illinois at Urbana-Champaign

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Naiman A Khan, PhD, RD

nakhan2@illinois.edu

Principal Investigator:

Naiman A Khan, PhD, RD

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Apr 15, 2021

Last verified

Apr, 2021

Keywords

  • Multiple Sclerosis
  • Cognitive Function
  • Lutein

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2021-04-15.