Intermittent Fasting in Multiple Sclerosis

RRMS patients will be enrolled in a randomized, controlled, single-blinded 12 week trial in
which IF will be compared to a standard western diet. Patients will be recruited at the John
L. Trotter MS center and randomly assigned to either a standard western diet or an IF diet
(1:1). Enrolled subjects will complete a clinical and laboratory assessment before starting
the diet (baseline), at week 6 and at end of the study (week 12). The primary outcome will be
leptin at week 12 measured in the peripheral blood. Secondary outcomes will be: 1) peripheral
blood metabolic profiling; 2) anthropometric (body mass index and waist circumference) and
total body fat measures; 3) gut microbiota richness and composition.

Inclusion Criteria:

- Diagnosis of RRMS (2010 Mc Donald criteria).

- EDSS <6.0 and disease duration ≤ 15 years.

- On an injectable therapy for MS, glatiramer acetate (GA) or beta-interferon (beta-IFN)
for at least 3 months prior to the study and with no anticipated changes of the
medication for the 12 week study duration.

- Age ≥18 years.

- BMI > 22 and < 35 kg/m2 with stable weight in the 3 months prior to screening.

Exclusion Criteria:

- History of any chronic disease process (excluding MS) that could interfere with
interpretation of results.

- Diagnosis in the past of an eating disorder (anorexia, bulimia, or binge eating).

- Relapsing at the time of enrollment.

- On corticosteroid treatment (oral or intravenous) in the past month. Nasal
corticosteroid treatments are allowed.

- Diagnosis of diabetes or at time of OGTT (fasting glucose >126 mg/dl or > 200 mg/dl at
2 hours with a load of 75 g of glucose

- History of food allergies or food intolerance that would interfere with the study.

- History of antibiotic treatment within the past 3 months prior to enrollment

- Use of anticoagulant drugs (like Warfarin or Coumadin) that need to monitor their
intake of vegetables containing high levels of vitamin K.

- Currently on a special diet and not willing to stop at least one month prior to
enrollment

- Currently taking omega 3/fish oil supplements and not willing to stop administration
one month prior to enrollment

- Currently pregnant or plan to become pregnant within 6 months

- Current tobacco or e-cigarette smoker