Status:
RECRUITING
Effect of a Fasting Mimicking Diet on Patients With Multiple Sclerosis (FMDMS)
Lead Sponsor:
University of Southern California
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief 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 (RM...
Detailed Description
The study design is a cross-over randomized, controlled trial that includes two arms in which all patients will be on a MD for twelve months. One group will be on MD alone for 6 months and then do 3 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06515782
Start Date
October 20 2023
End Date
October 20 2025
Last Update
July 23 2024
Active Locations (1)
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1
Keck School of Medicine of the University of Southern California
Los Angeles, California, United States, 90033