Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis
Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis
A key question in efforts to reduce symptoms and improve quality of life for multiple
 sclerosis (MS) patients is whether a therapeutic lifestyle (diet, stress reduction and
 exercise) is inferior to disease-modifying drug treatments in terms of reducing multiple
 sclerosis related symptoms, improving function and quality of life, and reducing the number
 of acute inflammatory lesions and loss of brain volume. This study will prospectively assess
 the changes in quality of life and clinical outcomes in two cohorts of patients who are
 recently diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple
 sclerosis (RRMS) to begin answering that question.

 The goal of this project is to compare a diet and therapeutic lifestyle only treatment usual
 care in the setting of newly diagnosed individuals with RRMS or CIS, which is the precursor
 to the development of MS.
The goal of this project is to compare a diet and therapeutic lifestyle only treatment usual
 care in the setting of newly diagnosed individuals with RRMS or CIS, which is the precursor
 to the development of MS. The current standard of care typically includes disease-modifying
 drug treatment at the initial diagnosis of RRMS or CIS. Many patients are interested in
 adopting a therapeutic lifestyle as their initial approach to either RRMS or CIS. Some
 patients decline drug therapy due to high costs and or concerns about potential medication
 adverse events. There are no known scientific studies that have prospectively assessed
 outcomes for newly-diagnosed patients who decline disease-modifying drug treatment and
 instead utilized only a therapeutic diet and lifestyle to manage their MS-related symptoms.
 This study will prospectively investigate the effect of a therapeutic diet and lifestyle on
 quality of life, motor, cognitive and visual function, and brain structure in patients who
 have been trained and supported by the study team to utilize therapeutic diet and lifestyle
 to optimize neuronal health and those who are receiving usual care.

 Our initial pilot study in the setting of progressive MS included diet and targeted
 supplements, stress reduction, exercise, and electrical stimulation of muscles and
 demonstrated significant reduction in fatigue, improvement in quality of life and improved
 mood and cognition. Subsequent pilot studies which utilized a diet-only intervention in the
 setting of RRMS demonstrated improved quality of life and improved walking and hand function.

 Intervention arm:

 This study will again utilize a multimodal approach, a low-lectin modified Paleolithic diet,
 stress reduction (breathing meditation exercise) and an exercise (daily walking and three
 times a week body weight strengthening) program in the absence of drug disease modifying
 treatment and targeted supplements in the intervention arm. The control arm will receive
 usual care.

 Supplements (intervention arm only) Participants will be asked to continue taking any dietary
 supplements they report at beginning of study with the exception of supplements that are
 similar to those they will be taking as part of the study which they will be asked to
 discontinue and replace with study-approved brands (2 grams of fish oil, 1000 mcg methylB12 ,
 400 mcg methyl folate, pyridoxine 1.5 mg and N acetylcysteine 500 mg per day, and 2000 IU
 vitamin D3 .

 The study will use videos from a three day seminar that teaches the public how to utilize a
 therapeutic diet and lifestyle to improve cellular physiology which may favorably impact
 disease progression to educate study participants. A registered dietitian with training in
 motivational interviewing and health coaching will call participants to provide coaching and
 support to participants as they adopt the study diet, breathing meditation and exercise
 program and begin the study supplements. The study coordinator and or registered dietitian
 will moderate monthly support group video conference meetings for participants in the
 intervention arm. The control arm will receive a monthly text/ email providing a summary to a
 recently published clinical trial related to multiple sclerosis / clinically isolated
 syndrome patients that is not related to diet quality or use of a therapeutic diet or
 lifestyle.

 AIMS Aim 1: To assess the magnitude of change in perceived quality of life over 12 months in
 newly-diagnosed, disease modifying drug treatment naïve RRMS or CIS patients within and
 between two groups. Group one will receive standard of care. Group two will receive a
 therapeutic diet and lifestyle intervention that is taught and supported virtually.
Inclusion Criteria:

 -  1) A diagnosis of clinically isolated syndrome (CIS) or relapsing-remitting multiple
 sclerosis (RRMS) or CIS according to the 2010 McDonald's criteria, confirmed by the
 treating neurologist within 12 months of completing the first study visit.2) Must
 consent to sharing the clinical notes from their primary care and neurology providers
 during the study period.3) Must reside within the lower 48 states within the United
 States.4) Agreement by the treating neurologist that the patient may enroll in the
 study.

 Exclusion Criteria:

 1) Moderate or severe mental impairment as measured by the Short Portable Mental Health
 Questionnaire. 2) Presence of a contraindication to completing a brain MRI or having
 claustrophobia which interferes with completion of MRI studies without the use of sedation.
 3) Taking insulin or Coumadin® medication. 4) History of oxalate kidney stones,
 schizophrenia, or active diagnosis of eating disorder. 5) Greater than 12 months since
 initial diagnosis of RRMS or CIS and first study visit.