RECRUITINGINTERVENTIONAL

Effect of a Fasting Mimicking Diet on Patients With Multiple Sclerosis (FMDMS)

Effect of Fasting Mimicking Diet on Measures of Inflammatory Disease in Relapsing Multiple Sclerosis (RMS) Patients Treated With Standard Disease Modifying Therapies

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosis of MS (AJ Thompson et al 2018) - Able to give willing to sign a consent form - Able to tolerate MRI - Age 18 to 55 years - Disease duration 6 months to 20 years (included) - EDSS 0 to 6 - No change in immunomodulatory therapy in the 6 months prior to enrollment (not on immunomodulatory therapy is acceptable) - No glucocorticoid use within 30 days prior to screening - No serologic evidence of vitamin B12 deficiency or hypothyroidism - No Vitamin D deficiency (\< 30 ng/ml) Who Should NOT Join This Trial: - Relapse \< 60 days. - Any active or chronic infection (e.g. HIV, Syphilis, untreated TB) - 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 - History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts - Pregnancy or risk of pregnancy (this includes patients who are unwilling to practice active contraception during the duration of the study) - eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination - Inability to give written willing to sign a consent form in accordance with research ethics board guidelines - Known alimentary allergy or intolerance to any of the ingredients of the FMD regimen or the presence of diabetes - Underweight Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Diagnosis of MS (AJ Thompson et al 2018) * Able to give informed consent * Able to tolerate MRI * Age 18 to 55 years * Disease duration 6 months to 20 years (included) * EDSS 0 to 6 * No change in immunomodulatory therapy in the 6 months prior to enrollment (not on immunomodulatory therapy is acceptable) * No glucocorticoid use within 30 days prior to screening * No serologic evidence of vitamin B12 deficiency or hypothyroidism * No Vitamin D deficiency (\< 30 ng/ml) Exclusion Criteria: * Relapse \< 60 days. * Any active or chronic infection (e.g. HIV, Syphilis, untreated TB) * 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 * History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts * Pregnancy or risk of pregnancy (this includes patients who are unwilling to practice active contraception during the duration of the study) * eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination * Inability to give written informed consent in accordance with research ethics board guidelines * Known alimentary allergy or intolerance to any of the ingredients of the FMD regimen or the presence of diabetes * Underweight

Treatments Being Tested

OTHER

Med Diet. Investigators would like to see what differences a Mediterranean Diet makes to the status of patients with Multiple Sclerosis.

In one group investigators will look at the Med diet alone for 6 months. Then investigators will have the patients add on 3 rounds of FMD. In the other group, patients will do Med diet and FMD for 6 months followed by Med diet alone for 6 months. This will allow investigators to look for a diminution in effect of the Med diet 6 months after the last FMD.

Locations (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, United States