RECRUITING

Effect of a Fasting Mimicking Diet on Patients With Multiple Sclerosis (FMDMS)

Conditions

Multiple Sclerosis fasting Mediterranean diet body composition quality of life

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Fasting Mimicking Diet on Measures of Inflammatory Disease in Relapsing Multiple Sclerosis (RMS) Patients Treated With Standard Disease Modifying Therapies

Quick Facts

Study Start:2023-10-20

Study Completion:2025-10-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06515782

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Frida Hovik, MS RDN

CONTACT

949-357-0653

Frida.Hovik@med.usc.edu

Principal Investigator

Margaret E Burnett, MD

PRINCIPAL_INVESTIGATOR

University of Southern California Keck School of Medicine

Study Locations (Sites)

Keck School of Medicine of the University of Southern California

Los Angeles, California, 90033

United States

Collaborators and Investigators

Sponsor: University of Southern California

Margaret E Burnett, MD, PRINCIPAL_INVESTIGATOR, University of Southern California Keck School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-20

Study Completion Date2025-10-20

Study Record Updates

Study Start Date2023-10-20

Study Completion Date2025-10-20

Terms related to this study

Keywords Provided by Researchers

fasting
Mediterranean diet
body composition
quality of life

Additional Relevant MeSH Terms

Multiple Sclerosis