NCT04843813

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

April 7, 2021

Last Update Submit

April 12, 2021

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisCognitive FunctionLutein

Outcome Measures

Primary Outcomes (5)

  • Macular Pigment Optical Density

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

    4 months (baseline vs. follow-up)

  • Attentional Accuracy

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

    4 months (baseline vs. follow-up)

  • Attentional Reaction Time

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

    4 months (baseline vs. follow-up)

  • Attentional Resource Allocation

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

    4 months (baseline vs. follow-up)

  • Attentional Processing Speed

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

    4 months (baseline vs. follow-up)

Study Arms (2)

Lutein

EXPERIMENTAL
Dietary Supplement: Lutein

Safflower Oil

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

LuteinDIETARY_SUPPLEMENT

Participants will consume daily soft gels containing the lutein supplement.

Lutein
PlaceboDIETARY_SUPPLEMENT

Participants will consume daily soft gels containing the safflower oil.

Safflower Oil

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 or corrected vision
  • No presence of color blindness
  • No history of age-related macular degeneration
  • No history of epileptic seizures

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

Related Publications (1)

  • Martell SG, Kim J, Cannavale CN, Mehta TD, Erdman JW Jr, Adamson B, Motl RW, Khan NA. Randomized, Placebo-Controlled, Single-Blind Study of Lutein Supplementation on Carotenoid Status and Cognition in Persons with Multiple Sclerosis. J Nutr. 2023 Aug;153(8):2298-2311. doi: 10.1016/j.tjnut.2023.06.027. Epub 2023 Jun 25.

    PMID: 37364683DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Lutein

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

XanthophyllsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Naiman Khan, PhD

    University of Illinois Urbana Champaign

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naiman Khan, PhD, RD

CONTACT

217-300-2197nakhan2@illinois.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A 2-group parallel design will be employed to collect feasibility data on daily lutein supplementation over 4 months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 14, 2021

Study Start

March 26, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

April 15, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)