Fasting Mimicking Diet for Multiple Sclerosis

(FMDMS Trial)

Overseen By Frida Hovik, MS RDN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Must not be taking: Glucocorticoids

Disqualifiers: Active infection, Malignancy, Pregnancy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require no changes in immunomodulatory therapy for 6 months before joining. You also cannot have used glucocorticoids within 30 days before starting the trial.

What data supports the effectiveness of the treatment Fasting Mimicking Diet for Multiple Sclerosis?

Research shows that a fasting mimicking diet (FMD) can reduce symptoms and promote nerve repair in animal models of multiple sclerosis. In some studies, FMD has been linked to reduced inflammation and improved immune function, which may help manage MS symptoms. ^{1 2 3 4 5}

Is the Fasting Mimicking Diet safe for humans?

Preliminary data suggests that the Fasting Mimicking Diet is safe and feasible for people with relapsing-remitting multiple sclerosis, although more clinical evidence is needed. ^{1 2 3 5 6}

How is the Fasting Mimicking Diet treatment different from other treatments for multiple sclerosis?

The Fasting Mimicking Diet (FMD) is unique because it mimics the effects of fasting without requiring complete food abstinence, potentially reducing inflammation and promoting nerve repair in multiple sclerosis. Unlike traditional drug treatments, FMD involves periodic cycles of reduced calorie intake, which may improve symptoms and disease progression by increasing beneficial immune cells and reducing harmful ones. ^{1 2 4 5 6}

Research Team

Margaret E Burnett, MD

Principal Investigator

University of Southern California Keck School of Medicine

Eligibility Criteria

This trial is for patients with relapsing Multiple Sclerosis who are already on standard therapies. Participants should be willing to follow a special diet plan. Specific details about who can or cannot join the study based on health conditions, medications, or other factors aren't provided here.

Inclusion Criteria

I haven't taken any glucocorticoids in the last 30 days.

I am between 18 and 55 years old.

I haven't changed my immune system therapy in the last 6 months.

Exclusion Criteria

My kidney function is reduced, or I cannot have an MRI.

Pregnancy or risk of pregnancy (this includes patients who are unwilling to practice active contraception during the duration of the study)

Inability to give written informed consent in accordance with research ethics board guidelines

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a Mediterranean diet for 12 months, with one group undergoing 3 cycles of a 7-day Fasting Mimicking Diet (FMD) during the first 6 months, and the other group undergoing FMD cycles in the second 6 months.

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on quality of life, neurological status, and immune function.

6 months

Treatment Details

Interventions

• Fasting Mimicking Diet

Trial Overview The study is testing how a fasting mimicking diet (FMD) affects quality of life in MS patients compared to those following a Mediterranean Diet. It will look at disability, fatigue, and cognitive function improvements over six months.

Participant Groups

Group I: Arm 1: FMD + Mediterranean Diet Experimental Treatment 1 Intervention

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.

Group II: Arm 2: Mediterranean Diet + FMD Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Findings from Research

In a study involving 90 participants with multiple sclerosis, fasting-mimicking diets showed poor adherence overall, particularly with calorie restriction, despite no serious adverse events reported.

Time-restricted feeding (TRF) diets demonstrated better adherence compared to calorie restriction, suggesting that TRF may be a more feasible option for future dietary interventions in MS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of various fasting-mimicking diets among people with multiple sclerosis. Roman, SN., Fitzgerald, KC., Beier, M., et al.[2021]

A pilot study involving 12 adults with relapsing remitting multiple sclerosis (RRMS) found that time-restricted eating (TRE) was feasible and well-accepted, with a high retention rate of 92%.

Initial exploratory results suggest that TRE may positively impact symptoms like cognition, pain, and fatigue, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of time-restricted eating in a group of adults with multiple sclerosis. Wingo, BC., Rinker, JR., Green, K., et al.[2023]

In a study of 244 individuals who experienced a first clinical diagnosis of central nervous system demyelination, 38% reported making at least one dietary change within a year, primarily towards healthier options like increasing fruit and vegetable intake and adopting a low-fat diet.

The study highlights a trend among individuals with demyelination to seek healthier diets, but further research is needed to understand the motivations behind these changes and their potential impact on the progression of multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reported Changes in Dietary Behavior Following a First Clinical Diagnosis of Central Nervous System Demyelination. Russell, RD., Lucas, RM., Brennan, V., et al.[2022]

While no specific diet has been definitively proven to prevent relapses or lesions in multiple sclerosis (MS) patients, various dietary plans have shown promise in alleviating MS-related symptoms, such as fatigue and mood improvement.

Diets like the Mediterranean diet not only help with MS symptoms but also effectively prevent and reduce the severity of related health issues, highlighting their potential benefits for overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Approaches to Treating Multiple Sclerosis-Related Symptoms. Wahls, TL.[2022]

Periodic 3-day cycles of a fasting mimicking diet (FMD) significantly reduced clinical severity and reversed symptoms in 20% of mice with experimental autoimmune encephalomyelitis (EAE), a model for multiple sclerosis.

The FMD was associated with beneficial changes in immune response, including increased regulatory T cells and decreased pro-inflammatory cytokines, as well as promoting regeneration of oligodendrocytes, which are crucial for remyelination in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Diet Mimicking Fasting Promotes Regeneration and Reduces Autoimmunity and Multiple Sclerosis Symptoms. Choi, IY., Piccio, L., Childress, P., et al.[2022]

This study will evaluate the effects of a ketogenic diet (KD) and a fasting diet (FD) on disease progression in 111 patients with relapsing-remitting multiple sclerosis (MS) over 18 months, comparing them to a standard diet.

The primary outcome will be measured by the number of new MRI lesions, while secondary outcomes will assess safety, relapse rates, disability progression, and other health markers, addressing the need for alternative treatments with potentially fewer side effects than traditional medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study. Bahr, LS., Bock, M., Liebscher, D., et al.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and feasibility of various fasting-mimicking diets among people with multiple sclerosis. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of time-restricted eating in a group of adults with multiple sclerosis. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Reported Changes in Dietary Behavior Following a First Clinical Diagnosis of Central Nervous System Demyelination. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Dietary Approaches to Treating Multiple Sclerosis-Related Symptoms. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Diet Mimicking Fasting Promotes Regeneration and Reduces Autoimmunity and Multiple Sclerosis Symptoms. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study. [2020]