Effect of a Fasting Mimicking Diet on Patients With Multiple Sclerosis (FMDMS)
NCT Number: NCT06515782
Acronym: FMDMS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Sclerosis
Interventions: OTHER: Med Diet. Investigators would like to see what differences a Mediterranean Diet makes to the status of patients with Multiple Sclerosis.
Sponsor: University of Southern California
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-10-20
Completion Date: 2025-10-20
Locations: Keck School of Medicine of the University of Southern California, Los Angeles, California, 90033, United States

Summary:
In the proposed study, investigators will assess the safety and feasibility of cycles of a fasting mimicking diet (FMD) and its effect on Multiple Sclerosis Quality of Life (MSQOL) in relapsing MS (RMS) patients treated with standard disease modifying therapies (FMDMS).

To test the primary hypothesis, investigators will compare the composite quality of life score in terms of improvement in disability, fatigue, and cognitive function with the fasting protocol, as compared to a Mediterranean diet (control) group alone. Further, investigators hypothesize that the effects will remain for at least 6-months after the last FMD cycle. The Mediterranean diet (MD) has been chosen as the control diet to minimize baseline dietary differences among patients. It has been trialed for feasibility in Multiple Sclerosis patients and used in a previous human FMD trial for MS patients where a FMD followed by MD was shown to have positive effects on people with MS.

Primary Outcome Measures: Health-related Quality of Life (HRQOL), Improvement in disability, fatigue and cognitive function. Scale and composite scores range from 0 to 100, where a higher score indicates a better QOL., 12 months
Secondary Outcome Measures: Assessing Safety and Tolerability of a FMD in MS: Compliance and Serious Adverse Events, To evaluate the safety and tolerability of a FMD will be assessed using assessed using a standardized safety questionnaire. Adverse events will be scored utilizing Common Terminology Criteria for Adverse Events (CTCAE), 12 months|To evaluate the effect on clinical measures of neurological status: Annualized relapse rate, Relapses will be verified by clinical visit, history, and possible imaging. Rates will be analyzed per year, 12 months|To evaluate the effect on clinical measures of neurological status: EDSS, Expanded disability status score (EDSS): A verified instrument to verify the disability of the patient. The score range from 0-10 with larger numbers indicating worse disability., 12 months|To evaluate the effect on clinical measures of neurological status: depression, anxiety, We will assess anxiety and depression using Hospital Anxiety and Depression Scale (HADS). The score range from 0-21 with smaller numbers being better, 12 months|To evaluate body composition, Changes in body composition: BMI (Weight and height will be combined to report BMI: kg/m\^2), 12 months|To evaluate IGF-1 changes, Changes in Insulin like growth factor 1 (IGF-1) (ng/mL) which measure FMD effectiveness and a lower animal protein intake., 12 months|To estimate changes in measures of disease activity in the central nervous system (CNS), Number and volume of new and enlarging lesions detected by MRI. Units Cm\^2, 12 months|To estimate changes in measures of disease activity in the central nervous system (CNS), Changes in serum concentrations of neurofilament light chain (NF-L). Units: ng/L, 12 months|To evaluate alterations in immune function by assessing changes in cell counts, serum cytokines and secretion patterns, with a focus on pro-inflammatory cytokines IL-2, interferon-gamma (IFNγ), and IL-17A, and the regulatory cytokine, IL-10. Units: pg/mL, It is known that lymphocyte counts decrease during fasting., 12 months|To evaluate changes following the FMD in the composition and function of the gut microbiota which influences immune function in the T and B cells compartment in the blood., It has been shown that patients with MS have moderate alterations of gut microbial communities. Units: μm, 12 months