Time Restricted Eating Outcomes in Multiple Sclerosis
Condition: Multiple Sclerosis; Diet, Healthy
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

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.
    

Intervention name(s): Time Restricted Feeding
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment