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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a fasting mimicking diet (FMD) can improve life for people with relapsing Multiple Sclerosis (MS). Researchers aim to determine if this diet reduces disability, fatigue, and cognitive issues more effectively than a Mediterranean diet. Participants will start with one diet and then switch to the other to identify which works best. It suits those diagnosed with MS who have managed the condition for 6 months to 20 years and have not recently changed their main MS treatment. As an unphased trial, this study provides a unique opportunity to explore innovative dietary approaches that could enhance the quality of life for MS patients.

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 prior data suggests that this fasting mimicking diet is safe for multiple sclerosis patients?

Research has shown that fasting-mimicking diets (FMD) are generally safe for people with multiple sclerosis. Studies have found that most individuals tolerate FMD well, though some may find it challenging to adhere to. Reports suggest possible benefits, such as symptom improvements, but the primary focus remains on safety. The studies reviewed have identified no major safety issues, offering reassurance to those considering participation in a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fasting Mimicking Diet (FMD) for Multiple Sclerosis (MS) because it offers a novel approach by mimicking the effects of fasting, potentially reducing inflammation and promoting cellular repair without the need for prolonged fasting. Unlike standard MS treatments, which often involve medications like interferons or monoclonal antibodies targeting the immune system, FMD focuses on dietary intervention to achieve similar benefits. Additionally, when combined with the Mediterranean diet, which is rich in anti-inflammatory foods, it may provide a synergistic effect that enhances overall well-being and disease management. This approach could be a game-changer for those seeking non-pharmacological options to manage their condition.

What evidence suggests that the Fasting Mimicking Diet could be effective for Multiple Sclerosis?

Research has shown that the fasting mimicking diet (FMD) could benefit people with multiple sclerosis (MS). In animal studies, FMD reduced symptoms and, in some cases, even completely reversed them. These studies also found that FMD can help repair nerve damage. Another study suggested that FMD might slow aging in MS patients, potentially improving their overall health. Early data indicates that FMD might help manage MS symptoms. In this trial, participants will be assigned to different treatment arms to evaluate the effects of FMD in combination with a Mediterranean diet. These findings suggest that FMD could enhance the quality of life for people with MS. ^{1 4 5 6 7}

Who Is on the Research Team?

Margaret E Burnett, MD

Principal Investigator

University of Southern California Keck School of Medicine

Are You a Good Fit for This Trial?

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.

No Vitamin D deficiency (< 30 ng/ml)

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4899145/

Diet mimicking fasting promotes regeneration and reduces ... The FMD reduced clinical severity in all mice, and completely reversed symptoms in 20% of the animals. These improvements were associated with increased ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2211124716305769

A Diet Mimicking Fasting Promotes Regeneration and ... We show that periodic 3-day cycles of a fasting mimicking diet (FMD) are effective in ameliorating demyelination and symptoms in a murine experimental ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ana.78044

Fasting Mimicking Diets Reverse Accelerated Biological ... FMDs, particularly intermittent CR and KDMAD, can reduce accelerated metabolomic aging observed in MS. The mAge may serve as a measurable target ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034824003213

Intermittent and periodic fasting – Evidence and ... Preliminary data on fasting-mimicking diet and chronic ketogenic diet in MS showed that these diets could be potentially effective in the treatment of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10832063/

The effects of intermittent fasting for patients with multiple ... These findings led the researchers to conclude that intermittent fasting emerges as a safe and viable approach to weight loss in individuals afflicted with MS.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S221103482030225X

Safety and feasibility of various fasting-mimicking diets ... Fasting-mimicking diets are safe among people with multiple sclerosis. Adherence to calorie restriction diets is poor despite clinical support.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32408153/

Safety and feasibility of various fasting-mimicking diets ... Background: Fasting-mimicking diets have shown promise in experimental autoimmune encephalitis and are currently being investigated among people ...