Wahls Paleo Diet and Progressive Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional

Summary: 
      Based on favorable preliminary data from ongoing studies testing the safety and tolerability
      of a nutrition, exercise and neuromuscular electrical stimulation funded by Direct MS, the
      investigators are proposing a pilot study focused on the Wahls Paleo plus Diet and Wahls Diet
      intervention to usual care. The intent is to measure the effect size of a Wahls Paleo plus
      Diet and the effect size of the Wahls Diet in reducing fatigue and improving quality of life
      scores as measured by fatigue severity scale score and MS quality of life 54 physical and
      mental scores and various subscale scores. Inclusion criteria is the presence of fatigue and
      the diagnosis secondary and primary progressive MS, progressive relapsing MS or
      relapsing-remitting MS with an expanded disability status scale score (EDSS) score of 4.5 or
      greater but otherwise stable medically. The Wahls Paleo plus (ketogenic diet) and the Wahls
      diet (modified paleolithic diet) groups will be instructed in completing a daily food log and
      receive coaching from registered dieticians who are expert in motivational interviewing. The
      control group will receive usual care. Biomarkers of nutrient levels (e.g. vitamin) and
      inflammation, blood sugar and insulin levels will be monitored. Additional blood will be
      frozen for future analysis. Nutrient (e.g. vitamin and antioxidant) intake will be assessed
      using food frequency questionnaires and 24 hr diet recalls. Test of endothelial function will
      be done at baseline and 12 weeks. Outcome measures will be change in quality of life and
      fatigue, endothelial function and blood biomarkers between enrollment and end of study at 12
      weeks. The hypotheses are that the diet intervention groups will experience reduced fatigue
      and improved quality of life and improved biomarkers 1) between zero and 12 weeks and that
      the wahls paleo plus (ketogenic diet) and the wahls diet (modified paleolithic diet) groups
      will experience more improvements in quality of life and reduced fatigue and in biomarkers
      than the usual care group experiences at 12 weeks. The usual care group will be given
      instruction in following both the wahls paleo plus and the wahls diet plans and how to
      utilize the daily food logs at the end of study visit. The usual care group will receive one
      nutrition coaching call to assist with implementation of the study diet.
    

Detailed description: 
      Specific Aim 1. To assess changes in fatigue severity (primary outcome measure) and quality
      of life, motor, cognitive and emotional functions (secondary measures) the intervention
      groups (wahls paleo plus and wahls diet group)to usual care.

      Hypothesis 1a: The Wahls Paleo plus group and the wahls diet group will both demonstrate more
      improvements in quality of life and fatigue between baseline and 12 weeks than usual care
      group.

      Hypothesis 1b. The wahls paleo plus group will demonstrate more improvement in quality of
      life and fatigue than the wahls diet group.

      Specific Aim 2. To assess changes in the blood biomarkers and endothelial function as the
      subject progresses through the study interventions.

      Hypothesis 2a: The wahls paleo plus and the wahls diet group will demonstrate more favorable
      changes in blood biomarkers obtained at baseline and week 12 than the usual care group.

      Hypothesis 2b: The wahls paleo plus group will demonstrate more favorable changes in blood
      biomarkers and quality of life than the wahls diet group experiences obtained at baseline and
      week 12.

      Hypothesis 2c: The wahls paleo plus and the wahls diet group will demonstrate more favorable
      changes in measures of endothelial function between baseline and week 12 than will be
      observed in the usual care group.

      Hypothesis 2d: The wahls paleo plus will demonstrate more favorable changes in measures of
      endothelial function between baseline and week 12 than the wahls diet group.
    

Intervention name(s): Wahls Paleo Plus; Wahls Diet
Intervention type(s): Other; Other
Intervention description(s): The study diet is based upon a Paleolithic Diet, also known as a Hunter Gatherer Diet, which exceeds the recommended daily allowance of water soluble vitamins and minerals 1.5 to 8 fold and improves lipids, inflammatory biomarkers and blood pressure. The study diet is further structured to be a low in carbohydrate and high in fat but still ensure consumption of the specific micronutrients important to optimal brain function. This diet is designed to induce a low level nutritional ketosis.; The study diet is based upon a Paleolithic Diet, also known as a Hunter Gatherer Diet, which exceeds the recommended daily allowance of water soluble vitamins and minerals 1.5 to 8 fold and improves lipids, inflammatory biomarkers and blood pressure. The study diet is further structured to be a low glycemic diet and also ensure consumption of the specific micronutrients important to optimal brain function.
Other intervention name(s): Wahls Paleo Plus (ketogenic diet); Wahls Diet (modified paleolithic diet)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Secondary Progressive Multiple Sclerosis; Primary Progressive Multiple Sclerosis; Relapsing progressive multiple sclerosis; relapsing remitting multiple sclerosis; Fatigue; Quality of life; Paleo; Nutrition; Ketogenic