NCT03539094.

Study name	Intermittent Fasting in Multiple Sclerosis (IFMS)
Methods	Randomised controlled trial
Participants	60 participants Ages Eligible for Study: 18 years and older (adult, older adult) Sexes Eligible for Study: all Accepts Healthy volunteers: no 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
Interventions	Arm Intervention/treatment Experimental: Intermittent fasting The participants randomised to this group will do IF by restricting their diet and consuming few calories two days per week. During the days of fasting, participants will be allowed to drink water, calorie‐free beverages, and eat fresh, steamed or roasted non‐starchy vegetables. Other: intermittent fasting the participants randomised to this group will do IF by restricting their diet and consuming few calories two days per week. During the days of fasting, subjects will be allowed to drink water, calorie‐free beverages, and eat fresh, steamed or roasted non‐starchy vegetables. No Intervention: Western diet The participants randomised to this group will eat a standard Western style diet.
Outcomes	Primary Outcome Measures Leptin [ Time Frame: 12 weeks ] Leptin at week 12 measured in the peripheral blood Secondary Outcome Measures Peripheral metabolic and inflammatory profiling [ Time Frame: 12 weeks ] Adipokine and inflammatory markers at week 12 measured in the peripheral blood Anthropometric measure [ Time Frame: 12 weeks ] Weight and height will be combined to report BMI in kg/mg^2 Anthropometric measure [ Time Frame: 12 weeks ] Waist circumference in cm Gut microbiota [ Time Frame: 12 weeks ] Gut microbiota richness and composition
Starting date	January 1, 2018
Contact information	picciol@neuro.wustl.edu
Notes	NCT03539094