A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis (FAST-MS)
Multiple Sclerosis
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring fasting mimicking diet, multiple sclerosis
Eligibility Criteria
Inclusion Criteria: Diagnosis of RRMS (Thompson et al. 2018); Disease duration 6 months to 10 years (included); EDSS 0 to 4, 5; Treatment with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate). Exclusion Criteria: < 6 months since treatment start with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate); Relapse < 60 days; Any active or chronic infection; Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year; Severely limited life expectancy by another co-morbid illness; Nutritional risk screening (NRS 2002) > or = 3; BMI <= 18.5 kg/m2; Bio-impedance phase angle <5.0°; History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts;
Sites / Locations
- Ospedale San Martino
Arms of the Study
Arm 1
Experimental
7-DAY FMD
The 7-DAY FMD by L-Nutra is a low-calorie and low-protein diet that provides all the necessary micronutrients to prevent malnutrition. This medically-designed dietary kit supplies food for 7 days, with Day 1 providing 1100 kcal, while days 2 to 5 provide 800 kcal per day. The diet consists of ingredients that are Generally Regarded As Safe (GRAS), selected for their fasting mimicking properties. Patients will take the 7-DAY FMD once every 60 days.