Time Restricted Eating Outcomes in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to determine the preliminary efficacy, safety, and acceptability of time restricted feeding (TRF) among a sample of 12 adults with Relapsing-Remitting Multiple Sclerosis (RRMS). The specific aims of this study are: 1: To determine preliminary efficacy of TRF for reducing symptom burden, improving inflammatory markers, and reducing cardiometabolic risk among adults with RRMS. 2: To determine the safety and participant acceptability of TRF. Participants will be asked to consume all food during an 8-hour window each day and not eat for the remaining 16 hours. All participants will follow this eating pattern for 8 weeks.

Detailed Description
-----------------
Multiple sclerosis (MS) is a chronic autoimmune disease characterized by demyelination and loss of axons in the central nervous system. Over the last decade there has been an influx of evidence demonstrating the impact of lifestyle risk factors on the progression of MS symptoms. Specifically, epidemiological studies report that poor diet is associated with increased risk of disability in adults with MS. Despite this evidence, little research has explored dietary interventions that may reduce symptom burden of MS. One dietary intervention that has shown particular promise in animal models of MS is intermittent fasting (IF), which is a dietary pattern characterized by cycles of eating and extended fasting. There are a number of protocols for IF, including time restricted feeding (TRF), in which all food is consumed during a limited window of time each day. Growing evidence demonstrates that IF reduces inflammation, improves immune function, and improves cardiometabolic risk in animal models of MS, however, little of this research has been translated into human trials. In addition to these physiological benefits, the investigators believe that TRF will provide a behavioral benefit, as it addresses barriers traditionally seen in dietary interventions by shifting the focus from restricting what participants eat, to focusing on meal timing. The purpose of this pilot study is to determine the preliminary efficacy, safety, and acceptability of TRF in adults with MS. The specific aims of this study are: 1: To determine preliminary efficacy of TRF for reducing symptom burden, improving inflammatory markers, and reducing cardiometabolic risk among adults with RRMS. 2: To determine the safety and participant acceptability of TRF. Twelve adults with relapsing-remitting MS will eat all meals within an 8 hour period each day. All participants will follow the assigned meal plan for 8 weeks.

Official Title
-----------------
Time Restricted Eating Outcomes in Multiple Sclerosis

Conditions
-----------------
Diet, Healthy, Multiple Sclerosis

Intervention / Treatment
-----------------
* Behavioral: Time Restricted Feeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Relapsing Remitting MS (RRMS) BMI between 18-50 kg.m2 If on disease-modifying medications, stable for 6 months If not on disease-modifying medication, no medication usage within previous 6 months Able to walk 25 ft. with or without assistance Exclusion Criteria: Relapse within previous 30 days Actively engaged in a weight loss program or unwilling to follow assigned dietary timing pattern Regularly fasts >15 hours/day Pregnant or breastfeeding Current use of insulin or sulfonylurea agents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time Restricted Feeding<br>Participants will be asked to follow a time-restricted meal pattern (8:16 protocol) | Behavioral: Time Restricted Feeding<br>* Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Sclerosis Functional Composite Score (MSFC) | Scored as composite of three components: Timed 25-foot walk, 9 hole peg test, symbol digit modalities test | Change from baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form McGill Pain Questionnaire | 15-item questionnaire requiring respondent to rate types of pain as mild, moderate or severe | Change from baseline to 8 weeks | 
| Modified Fatigue Impact Scale | 21-item questionnaire providing scores on 3 components: physical, cognitive and psychosocial | Change from baseline to 8 weeks | 
| Fatigue Severity Scale | 9-item questionnaire in respondents rate each statement from strongly disagree to strongly agree | Change from baseline to 8 weeks | 
| Pittsburgh Sleep Quality Index | 19 self-rated items that produce 7 component scores and 1 global score | Change from baseline to 8 weeks | 
| Body composition | Dual energy x-ray absorptiometry (DXA) | Change from baseline to 8 weeks | 
| Insulin |  | Change from baseline to 8 weeks | 
| Blood pressure |  | Change from baseline to 8 weeks | 
| Continuous glucose monitoring | 24 hour glucose monitoring using subcutaneous monitor | Change from baseline to 8 weeks | 
| Tumor Necrosis Factor Alpha (TNFa) |  | Change from baseline to 8 weeks | 
| Interleukin 6 (IL-6) |  | Change from baseline to 8 weeks | 
| Interleukin 17 (IL-17) |  | Change from baseline to 8 weeks |