Utilization of the Ketogenic Diet in Patient With Relapsing Remitting MS
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the benefits of a low-carbohydrate, high-fat diet
      (ketogenic diet) in up to 50 subjects with relapsing-remitting multiple sclerosis (RRMS), a
      chronic neuro-inflammatory disease. The primary aim of this study is to provide evidence of
      tolerability of the ketogenic diet in patients with RRMS. The principal investigator
      hypothesizes that the diet may prove beneficial for participants disease state in multiple
      potential ways.The study consists of 5 visits over a 12 month period. During these visits
      subjects will undergo fasting lab work, micro-biome sampling, neurological testing, body
      composition analysis, meeting with dietitian, and will be asked to complete surveys as well
      as a diet recall log.
    

Detailed description: 
      The purpose of this study is to see if a high fat, low carbohydrate diet is safe and how it
      effects post trial diet habits, physique, and disease course in patients with relapsing
      remitting multiple sclerosis. In particular, multiple sclerosis is a neurodegenerative
      disorder that is characterized by inflammation, microglial inflammation, and hypoxia in its
      relapsing-remitting form.1 One of the hypothesized therapeutic mechanisms of ketogenic diets
      is related to its effect on decreasing glycolysis, decreasing reactive oxygen species (ROS),
      and increasing ATP production by mitochondria. Production of ROS and macrophage activation
      have been directly correlated with demyelination and axonal injury in multiple sclerosis.2,3
      In mouse models with experimental allergic encephalomyelitis (EAE), a model disease in mice
      that has many similar properties to that of MS in humans, experiments have demonstrated that
      impairment of memory and spatial learning are directly correlated with increased cytokine and
      chemokine expression and ROS production. In EAE mice fed a ketogenic diet, there were noted
      improvements in motor disability, memory dysfunction, and CNS inflammation - which on the
      whole are suggestive that a ketogenic diet may have a multitude of benefits in patients with
      multiple sclerosis.

      The study goal is to recruit 50 young adult or adult patients with relapsing-remitting
      multiple sclerosis that show interest in starting and maintaining a ketogenic diet for six
      months. Prior to initiating the diet, the study team will characterize each patient's disease
      by analyzing multiple factors - including baseline expanded disability status scale (EDSS)
      and annualized relapse rates (ARR). Throughout the course of the 12 month study participants
      will be asked to complete several patient reported outcomes, an online food diary recall, and
      track their diet compliance using urinary ketone testing strips provided by the study
      daily.In addition, the study team will also draw serum lab work every 3 months that we
      anticipate may be affected by the diet (including hemoglobin A1C, lipid panel, and cytokine
      profiles). Rectal swabs will be requested during the study to look at effects of the diet on
      the microbiome both pre and post diet. Additionally, activity monitors (accelerometers) will
      be worn by each subject for 1 week prior to initiation of the diet to provide evidence of
      pre-diet activity levels and at various times throughout the study for comparison.
      Participating patients will receive education on starting, maintaining, and stopping the 6
      month diet by a nutritionist. The nutritionist will meet with patients at scheduled office
      visits and will be available for questions during the duration of the patients participation.
      Subjects will also undergo anthropometric assessments with a bodpod used to measure body mass
      as well.

      All measures will be compared with statistical analyses, utilizing both pre and post diet
      values to help determine benefit of the diet on various aspects of the patient's overall
      health and wellness.
    

Intervention name(s): Modified Atkins diet
Intervention type(s): Other
Intervention description(s): High fat low carbohydrate diet.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with relapsing-remitting MS
      
Biospecimen description: 
      Rectal swab
    
Keywords: Ketogenic diet