Effect of a Fasting Mimicking Diet on 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

Status unknownNot a drug-phase studyRelapsing MSNCT06515782

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

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

What it measured

Main measures

  • Health-related Quality of Life (HRQOL)

    12 months

    Thinking and memoryFatigueQuality of life (reported by participants)

Other measures (9)

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

    12 months

    Safety

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

    12 months

    Relapses

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

    12 months

    Disability progression

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

    12 months

    Mood and sleep

  • To evaluate body composition

    12 months

    Physical function

  • To evaluate IGF-1 changes

    12 months

  • To estimate changes in measures of disease activity in the central nervous system (CNS)

    12 months

    MRI lesionsBlood or spinal fluid markersHow the body handles the medicine

  • To evaluate alterations in immune function by assessing changes in cell counts, serum cytokines and secretion patterns, with a focus on pro-inflammatory cytokines IL-2, interferon-gamma (IFNγ), and IL-17A, and the regulatory cytokine, IL-10. Units: pg/mL

    12 months

    Immune response

  • To evaluate changes following the FMD in the composition and function of the gut microbiota which influences immune function in the T and B cells compartment in the blood.

    12 months

    Immune response

Who could take part

Relapsing MS · 18 to 55 · EDSS 0 to 6

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Oct 2023

    2. Main results due

      Oct 2025

    3. Finished

      Oct 2025

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