Wahls Paleo Diet and Progressive Multiple Sclerosis

• Perceived Fatigue [ Time Frame: Baseline, weeks, 4,8 and 12 ] [ Designated as safety issue: No ]
  Fatigue as measured by the fatigue severity scale and the modified fatigue impact scale
  
  

• Biomarkers [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
  Biomarkers include weight, Body Mass Index,and blood biomarkers of renal and liver function, vitamin levels (A,C,K,D, B vitamins), homocysteine, h.s. c- reactive protein (CRP)
  
  
• Biomarkers - glucose and ketones [ Time Frame: Baseline and at 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  GLucose, insulin, ketones, hemoglobin a1c to assess insulin sensitivity. Full intervention at baseline, and weeks 4,8,12 Minimal intervention at baseline and week 12.
  
  
• 24 hr food recalls. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  The 24 hr recalls will be collected at baseline in in the last 4 weeks of study. This will include nutrient analyses as well.
  
  
• Daily Food logs [ Time Frame: Baseline through end of study (12 weeks) ] [ Designated as safety issue: No ]
  This is a record of daily food and beverage consumption. The two intervention groups will keep the record daily. The usual care group will keep the a food record the initial two weeks and for two weeks between weeks 10 and 12.
  
  
• MS functional composite score. [ Time Frame: Baseline and end of study (12 weeks) ] [ Designated as safety issue: No ]
  This a composite of tests involving tests of walking, hand coordination and mental addition.
  
  
• 6 minute walk test [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
  Subject will walk 6 minutes. They may rest as needed during the 6 minute time period. The total length of time that is walked will be recorded.
  
  
• Medical symptoms quest. (MSQ) [ Time Frame: Baseline, weekly through week 12 ] [ Designated as safety issue: No ]
  Scored review of systems questionaire
  
  
• Life spaces score [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
  Questions about the locations subjects has been in the prior time period of interest.
  
  
• Medication audit [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
  List of currently used medications, vitamins, supplements and over the counter medications.
  
  
• Physical examination [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
  Summary of physical findings from physical examination.
  
  
• Health questions [ Time Frame: baseline ] [ Designated as safety issue: No ]
  A list of questions to identify common medical comorbid conditions and their severity if present.
  
  
• MS Quality of Life (MSQoli 54) [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
  MS Qoli 54 is a series of questions about physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life.
  
  
• MS Quality of life inventory (MSQLI) [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
  MSQLI is a series of questions asking about daily life. Includes physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life.
  
  
• Demographic data [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
  Questions about demographic attributes such as race, education, handedness.
  
  
• Functional Medicine assessment summary [ Time Frame: Baseline or 12 weeks ] [ Designated as safety issue: No ]
  A series of questions about a number of environmental risk factors for development of neurological and medical symptoms. Completed prior to orientation to study intervention diet after randomization (intervention groups) or at 12 weeks for usual care group.
  
  
• Veteran Specific Activity Quest. [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: No ]
  Series of questions about the tasks of daily life to identify how much activity the individual can safely do.
  
  
• MS Function Scale [ Time Frame: baseline and week 12 ] [ Designated as safety issue: No ]
  A series of questions about the tasks of daily life.
  
  
• Satiety scale [ Time Frame: Baseline and weeks 10 and 11 ] [ Designated as safety issue: No ]
  A series of questions about the sense of satiety or sense of fullness.
  
  
• Harvard Food Frequency Quest. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  A series of questions about the frequency of a variety of foodstuffs to estimate nutrient intake.
  
  
• Brachial artery dilation (FMD)and endothelium-dependent dilation, EDD) and endothelium-independent dilation [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
  Brachial artery FMD and endothelium-independent dilation will be determined non-invasively using high-resolution ultrasonography.
  
  
• Expanded disability status score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  Assessment of disability status
  
  

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.