Effect of a Fasting Mimicking Diet on Patients With Multiple Sclerosis (FMDMS) (NCT06515782) | Clinical Trial Compass
UnknownNot Applicable
Effect of a Fasting Mimicking Diet on Patients With Multiple Sclerosis (FMDMS)
United States50 participantsStarted 2023-10-20
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.