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

Study Overview
=================
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.

Official Title
-----------------
Lutein and Multiple Sclerosis Experimental Study (LuMES)

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Dietary Supplement: Lutein
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A 2-group parallel design will be employed to collect feasibility data on daily lutein supplementation over 4 months.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lutein<br> | Dietary Supplement: Lutein<br>* Participants will consume daily soft gels containing the lutein supplement.<br>|
| Placebo Comparator: Safflower Oil<br> | Dietary Supplement: Placebo<br>* Participants will consume daily soft gels containing the safflower oil.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Cognitive Function, Lutein