Recruiting

Fasting Mimicking Diet

Sponsor:

University of Southern California

Code:

NCT06515782

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06515782

Start date

Oct 20, 2023

Status verified date

Jul, 2024

Completion date

Oct 20, 2025

Anticipated

Primary completion date

Oct 20, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm 1: FMD + Mediterranean Diet

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.

active comparator: Arm 2: Mediterranean Diet + FMD

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.

Interventions

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.

Primary outcome measure

  • Health-related Quality of Life (HRQOL) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Frida Hovik, MS RDN

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

Locations

Keck School of Medicine of the University of Southern California

Recruiting

Los Angeles, California, United States, 90033

More Information

Sponsor

University of Southern California

Last update posted

Jul 23, 2024

Last verified

Jul, 2024

Keywords

  • fasting
  • Mediterranean diet
  • body composition
  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2024-07-23.