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RECRUITING
NCT06515782
NA

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

Sponsor: University of Southern California

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-10-20

Completion Date

2025-10-20

Last Updated

2024-07-23

Healthy Volunteers

No

Interventions

OTHER

Med Diet. Investigators would like to see what differences a Mediterranean Diet makes to the status of patients with Multiple Sclerosis.

In one group investigators will look at the Med diet alone for 6 months. Then investigators will have the patients add on 3 rounds of FMD. In the other group, patients will do Med diet and FMD for 6 months followed by Med diet alone for 6 months. This will allow investigators to look for a diminution in effect of the Med diet 6 months after the last FMD.

Locations (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, United States