Fasting Mimicking Diet for Patients with Multiple Sclerosis
Effect of Fasting Mimicking Diet on Measures of Inflammatory Disease in Relapsing Multiple Sclerosis (RMS) Patients Treated With Standard Disease Modifying Therapies
This study is testing if a special diet that mimics fasting can help people with relapsing multiple sclerosis feel better and improve their quality of life while they are on their usual treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06515782 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of a fasting mimicking diet (FMD) in patients with relapsing multiple sclerosis (RMS) who are also receiving standard disease-modifying therapies. Participants will be randomly assigned to either a Mediterranean diet (MD) alone or to a regimen that includes cycles of FMD followed by MD. The primary goal is to assess improvements in quality of life, disability, fatigue, and cognitive function over a 12-month period. The study aims to determine the long-term effects of dietary changes on autoimmune disease management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 55 with a diagnosis of multiple sclerosis and stable disease status.
Not a fit: Patients with recent relapses, active infections, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and overall health outcomes for patients with multiple sclerosis.
How similar studies have performed: Preliminary data from previous studies suggest that fasting mimicking diets may have positive effects on health-related quality of life in MS patients, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California
- Keck School of Medicine of the University of Southern California — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Margaret E Burnett, MD — University of Southern California Keck School of Medicine
- Study coordinator: Frida Hovik, MS RDN
- Email: Frida.Hovik@med.usc.edu
- Phone: 949-357-0653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.