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New treatment option for Multiple Sclerosis
Official title Effect of a Fasting Mimicking Diet on Patients With Multiple Sclerosis (FMDMS)
ClinicalTrials.gov ID: NCT06515782
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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)
You likely can't join if
- 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...
- Pregnancy or risk of pregnancy (this includes patients who are unwilling to practice active contraception during the duration of the study)
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.