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

NCT06515782 | Recruiting DMC

• 1 other identifier: HS-21-00212
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

fasting; Mediterranean diet; body composition; quality of life

Outcome Measures

Primary Outcomes (1)

• Health-related Quality of Life (HRQOL)

  Improvement in disability, fatigue and cognitive function. Scale and composite scores range from 0 to 100, where a higher score indicates a better QOL.

  12 months

Secondary Outcomes (10)

• Assessing Safety and Tolerability of a FMD in MS: Compliance and Serious Adverse Events

  12 months

• To evaluate the effect on clinical measures of neurological status: Annualized relapse rate

  12 months

• To evaluate the effect on clinical measures of neurological status: EDSS

  12 months

• To evaluate the effect on clinical measures of neurological status: depression, anxiety

  12 months

• To evaluate body composition

  12 months

Study Arms (2)

Arm 1: FMD + Mediterranean Diet

EXPERIMENTAL

In the first 6 months, participants will start the Mediterranean diet and undergo 3 cycles of FMD. Participants will then switch to the Mediterranean diet alone for another 6 months.

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

Arm 2: Mediterranean Diet + FMD

ACTIVE COMPARATOR

Participants will start with Mediterranean diet alone for the first 6 months and after that they will undergo FMD for 3 cycles while still on a Mediterranean diet.

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

Interventions

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

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.

Also known as: Is there an additional change to status when patients undergo 3 rounds of fast mimicking diet?

Arm 1: FMD + Mediterranean Diet; Arm 2: Mediterranean Diet + FMD

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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)
• 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)

You may not qualify 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 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Fasting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Feeding Behavior; Behavior

Study Officials

• Margaret E Burnett, MD

  University of Southern California Keck School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frida Hovik, MS RDN

CONTACT

949-357-0653; Frida.Hovik@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: July 23, 2024
• Study Start: October 20, 2023
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

US (1)