Actively Recruiting
Effect of a Fasting Mimicking Diet on Patients With Multiple Sclerosis (FMDMS)
Led by University of Southern California · Updated on 2024-07-23
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of a Fasting Mimicking Diet on Patients With Multiple Sclerosis (FMDMS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Multiple Sclerosis according to AJ Thompson et al 2018
- Able to give informed consent
- Able to tolerate MRI
- Age between 18 and 55 years
- Disease duration from 6 months to 20 years
- Expanded Disability Status Scale (EDSS) score between 0 and 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 (less than 30 ng/ml)
You will not qualify if you...
- Relapse within the past 60 days
- Any active or chronic infection such as HIV, Syphilis, or untreated Tuberculosis
- Previous history of malignancy except basal cell carcinoma of the skin or carcinoma in situ in remission for more than one year
- Severely limited life expectancy due to other illnesses
- History of myelodysplasia, previous hematologic disease, or clinically relevant abnormalities of white blood cell counts
- Pregnancy or risk of pregnancy without active contraception during study
- Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73m2, known renal failure, or inability to undergo MRI
- Inability to give written informed consent
- Known allergy or intolerance to any ingredients of the fasting mimicking diet or presence of diabetes
- Underweight
AI-Screening
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Trial Site Locations
Total: 1 location
1
Keck School of Medicine of the University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
Research Team
F
Frida Hovik, MS RDN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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