Multiple SclerosisFMDMSNCT06515782
Effect of a Fasting Mimicking Diet on Patients With Multiple Sclerosis (FMDMS)
A study testing Med Diet. Investigators would like to see what differences a Mediterranean Diet makes to the status of patients with Multiple Sclerosis. in people with Multiple Sclerosis, run by University of Southern California at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Med Diet. Investigators would like to see what differences a Mediterranean Diet makes to the status of patients with Multiple Sclerosis.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2023to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Keck School of Medicine of the University of Southern California
Los Angeles, California, 90033
About this study
Official title: Effect of Fasting Mimicking Diet on Measures of Inflammatory Disease in Relapsing Multiple Sclerosis (RMS) Patients Treated With Standard Disease Modifying Therapies
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.
Read the detailed description
The study design is a cross-over randomized, controlled trial that includes two arms in which all patients will be on a MD for twelve months. One group will be on MD alone for 6 months and then do 3 rounds of a standardized 7-day FMD dietary regimen every 2 months. The other group will do the 3 cycles of FMD during the first 6 months, and the subsequent 6 months on the MD alone. This will allow investigators to test FMD effects on a defined background diet as well as tease out the effects of that diet alone. In addition, investigators will be able to assess long term effects of a FMD on an autoimmune disease.
Preliminary data from a phase I clinical study in MS suggest that a FMD is safe, feasible, and potentially effective in relapsing-remitting multiple sclerosis (RRMS) patients (registered in Clinical Trials ID: NCT01538355). This study demonstrated a positive effect on health-related quality of life (HRQOL) components and a small effect on disability after one round FMD followed by a Mediterranean diet for 5 months.
A successful trial will provide relevant information about the efficacy and safety of these dietary interventions in MS patients and help confirm the positive effects seen in previous studies. In addition it is designed to elucidate the physiologic and immunologic effects of dietary changes and could help clarify the complex interactions between nutrition and autoimmune disease.
- Conditions
- Multiple Sclerosis
- Being tested
- Med Diet. Investigators would like to see what differences a Mediterranean Diet makes to the status of patients with Multiple Sclerosis.
- Keywords
- fasting, Mediterranean diet, body composition, quality of life
- Medical subject headings
- Multiple Sclerosis, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Med Diet. Investigators would like to see what differences a Mediterranean Diet makes to the status of patients with Multiple Sclerosis.Other
Also called Is there an additional change to status when patients undergo 3 rounds of fast mimicking diet?
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Med Diet. Investigators would like to see what differences a Mediterranean Diet makes to the status of patients with Multiple Sclerosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (10)
Assessing Safety and Tolerability of a FMD in MS: Compliance and Serious Adverse Events
To evaluate the safety and tolerability of a FMD will be assessed using assessed using a standardized safety questionnaire. Adverse events will be scored utilizing Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 12 months
To evaluate the effect on clinical measures of neurological status: Annualized relapse rate
Relapses will be verified by clinical visit, history, and possible imaging. Rates will be analyzed per year
Measured: 12 months
To evaluate the effect on clinical measures of neurological status: EDSS
Expanded disability status score (EDSS): A verified instrument to verify the disability of the patient. The score range from 0-10 with larger numbers indicating worse disability.
Measured: 12 months
To evaluate the effect on clinical measures of neurological status: depression, anxiety
We will assess anxiety and depression using Hospital Anxiety and Depression Scale (HADS). The score range from 0-21 with smaller numbers being better
Measured: 12 months
To evaluate body composition
Changes in body composition: BMI (Weight and height will be combined to report BMI: kg/m^2)
Measured: 12 months
To evaluate IGF-1 changes
Changes in Insulin like growth factor 1 (IGF-1) (ng/mL) which measure FMD effectiveness and a lower animal protein intake.
Measured: 12 months
To estimate changes in measures of disease activity in the central nervous system (CNS)
Number and volume of new and enlarging lesions detected by MRI. Units Cm^2
Measured: 12 months
To estimate changes in measures of disease activity in the central nervous system (CNS)
Changes in serum concentrations of neurofilament light chain (NF-L). Units: ng/L
Measured: 12 months
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
It is known that lymphocyte counts decrease during fasting.
Measured: 12 months
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.
It has been shown that patients with MS have moderate alterations of gut microbial communities. Units: μm
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start20 Oct 2023
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Burnett, University of Southern California
- Investigators
- Margaret E Burnett, MD, Principal investigator, University of Southern California Keck School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515782
- Sponsor's protocol ID
- HS-21-00212
- Acronym
- FMDMS
- Status last verified
- Jul 2024
- First submitted
- 4 Dec 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fasting Mimicking Diet on Measures of Inflammatory Disease in Relapsing Multiple Sclerosis (RMS) Patients Treated With Standard Disease Modifying Therapies
- ClinicalTrials.gov ID
- NCT06515782
- Acronym / sponsor ID
- FMDMS / HS-21-00212
- Conditions
- Multiple Sclerosis
- Keywords
- fasting, Mediterranean diet, body composition, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study design is a cross-over randomized, controlled trial that includes two arms in which all patients will be on a MD for twelve months. One group will be on MD alone for 6 months and then do 3 rounds of a standardized 7-day FMD dietary regimen every 2 months. The other group will do the 3 cycles of FMD during the first 6 months, and the subsequent 6 months on the MD alone. This will allow investigators to test FMD effects on a defined background diet as well as tease out the effects of that diet alone. In addition, investigators will be able to assess long term effects of a FMD on an autoimmune disease.
Preliminary data from a phase I clinical study in MS suggest that a FMD is safe, feasible, and potentially effective in relapsing-remitting multiple sclerosis (RRMS) patients (registered in Clinical Trials ID: NCT01538355). This study demonstrated a positive effect on health-related quality of life (HRQOL) components and a small effect on disability after one round FMD followed by a Mediterranean diet for 5 months.
A successful trial will provide relevant information about the efficacy and safety of these dietary interventions in MS patients and help confirm the positive effects seen in previous studies. In addition it is designed to elucidate the physiologic and immunologic effects of dietary changes and could help clarify the complex interactions between nutrition and autoimmune disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: FMD + Mediterranean Diet | Experimental | Other: Med Diet. Investigators would like to see what differences a Mediterranean Diet makes to the status of patients with Multiple Sclerosis.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. |
| Arm 2: Mediterranean Diet + FMD | Active comparator | Other: Med Diet. Investigators would like to see what differences a Mediterranean Diet makes to the status of patients with Multiple Sclerosis.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 may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Med Diet. Investigators would like to see what differences a Mediterranean Diet makes to the status of patients with Multiple Sclerosis.Also: Is there an additional change to status when patients undergo 3 rounds of fast mimicking diet?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. | Other | Arm 1: FMD + Mediterranean Diet, Arm 2: Mediterranean Diet + FMD |
Primary outcome
Health-related Quality of Life (HRQOL)
Time frame: 12 months
Improvement in disability, fatigue and cognitive function. Scale and composite scores range from 0 to 100, where a higher score indicates a better QOL.
10 secondary outcomes
Assessing Safety and Tolerability of a FMD in MS: Compliance and Serious Adverse Events
Time frame: 12 months
To evaluate the effect on clinical measures of neurological status: Annualized relapse rate
Time frame: 12 months
To evaluate the effect on clinical measures of neurological status: EDSS
Time frame: 12 months
To evaluate the effect on clinical measures of neurological status: depression, anxiety
Time frame: 12 months
To evaluate body composition
Time frame: 12 months
To evaluate IGF-1 changes
Time frame: 12 months
To estimate changes in measures of disease activity in the central nervous system (CNS)
Time frame: 12 months
To estimate changes in measures of disease activity in the central nervous system (CNS)
Time frame: 12 months
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
Time frame: 12 months
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.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret E Burnett, MD principal investigator
University of Southern California Keck School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Med Diet. Investigators would like to see what differences a Mediterranean Diet makes to the status of patients with Multiple Sclerosis. in people with Multiple Sclerosis, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frida Hovik, MS RDN (949-357-0653, Frida.Hovik@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (HRQOL) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.