Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Cognitive Function, Lutein
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.
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_SUPPLEMENTLutein
Participants will consume daily soft gels containing the lutein supplement.
DIETARY_SUPPLEMENTPlacebo
Participants will consume daily soft gels containing the safflower oil.
Sponsors
Division of Nutritional Sciences, University of Illinois at Urbana-Champaign
National Institutes of Health (NIH)
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
A 2-group parallel design will be employed to collect feasibility data on daily lutein supplementation over 4 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attentional Processing Speed | 4 months (baseline vs. follow-up) | Changes in P3 event related potential latency (ms) between groups using a computerized flanker task |
| Macular Pigment Optical Density | 4 months (baseline vs. follow-up) | Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer |
| Attentional Accuracy | 4 months (baseline vs. follow-up) | Changes in accuracy (%) between groups using a computerized flanker task |
| Attentional Reaction Time | 4 months (baseline vs. follow-up) | Changes in reaction time (ms) between groups using a computerized flanker task |
| Attentional Resource Allocation | 4 months (baseline vs. follow-up) | Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task |
Countries
United States
Contacts
Primary ContactNaiman Khan, PhD, RD
Outcome results
None listed