Relapsing Remitting Multiple SclerosisIFMSNCT03539094
Intermittent Fasting in Multiple Sclerosis
A study testing Intermittent fasting in people with Relapsing Remitting Multiple Sclerosis, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a randomized controlled trial that will test the effects of intermittent fasting (IF) in subjects with relapsing-remitting MS (RRMS). The goal of this clinical trial is to acquire objective evidence regarding whether an IF diet has beneficial effects in MS patients.Two dietary regimens, IF and western diet… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Intermittent fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 20 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of RRMS (2010 Mc Donald criteria).
- EDSS <6.0 and disease duration ≤ 15 years.
- On an injectable therapy for MS, glatiramer acetate (GA) or beta-interferon (beta-IFN) for at least 3 months prior to the study and with no anticipated changes of the medication for the 12 week study duration.
- Age ≥18 years.
- BMI > 22 and < 35 kg/m2 with stable weight in the 3 months prior to screening.
Who cannot join
- History of any chronic disease process (excluding MS) that could interfere with interpretation of results.
- Diagnosis in the past of an eating disorder (anorexia, bulimia, or binge eating).
- Relapsing at the time of enrollment.
- On corticosteroid treatment (oral or intravenous) in the past month. Nasal corticosteroid treatments are allowed.
- Diagnosis of diabetes or at time of OGTT (fasting glucose >126 mg/dl or > 200 mg/dl at 2 hours with a load of 75 g of glucose
- History of food allergies or food intolerance that would interfere with the study.
Show all 12Show fewer
- History of antibiotic treatment within the past 3 months prior to enrollment
- Use of anticoagulant drugs (like Warfarin or Coumadin) that need to monitor their intake of vegetables containing high levels of vitamin K.
- Currently on a special diet and not willing to stop at least one month prior to enrollment
- Currently taking omega 3/fish oil supplements and not willing to stop administration one month prior to enrollment
- Currently pregnant or plan to become pregnant within 6 months
- Current tobacco or e-cigarette smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St Louis
St Louis, Missouri, 63110
About this study
Official title: Randomized Controlled Trial on Intermittent Fasting in Multiple Sclerosis
This is a randomized controlled trial that will test the effects of intermittent fasting (IF) in subjects with relapsing-remitting MS (RRMS). The goal of this clinical trial is to acquire objective evidence regarding whether an IF diet has beneficial effects in MS patients.Two dietary regimens, IF and western diet, will be compared in a randomized, controlled, single-blinded 12 week trial in RRMS patients. This is a single-center study.
Read the detailed description
RRMS patients will be enrolled in a randomized, controlled, single-blinded 12 week trial in which IF will be compared to a standard western diet. Patients will be recruited at the John L. Trotter MS center and randomly assigned to either a standard western diet or an IF diet (1:1). Enrolled subjects will complete a clinical and laboratory assessment before starting the diet (baseline), at week 6 and at end of the study (week 12). The primary outcome will be leptin at week 12 measured in the peripheral blood. Secondary outcomes will be: 1) peripheral blood metabolic profiling; 2) anthropometric (body mass index and waist circumference) and total body fat measures; 3) gut microbiota richness and composition.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Intermittent fasting
- Keywords
- Multiple Sclerosis, Intermittent fasting, western diet, microbiome
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fastingOther
the subjects randomized to this group will do IF by restricting their diet and consuming few calories two days per week. During the days of fasting, subjects will be allowed to drink water, calorie-free beverages, and eat fresh, steamed or roasted non-starchy vegetables.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting | Experimental | The subjects randomized to this group will do IF by restricting their diet and consuming few calories two days per week. During the days of fasting, subjects will be allowed to drink water, calorie-free beverages, and eat fresh, steamed or roasted non-starchy vegetables. Receives: Other: Intermittent fasting |
| Western diet | No intervention | The subjects randomized to this group will eat a standard western style diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leptin
Leptin at week 12 measured in the peripheral blood
Measured: 12 weeks
Secondary outcomes (4)
Peripheral metabolic and inflammatory profiling
Adipokine and inflammatory markers at week 12 measured in the peripheral blood
Measured: 12 weeks
Anthropometric measure
Weight and height will be combined to report BMI in kg/mg^2
Measured: 12 weeks
Anthropometric measure
Waist circumference in centimeters
Measured: 12 weeks
Gut microbiota
Gut microbiota richness and composition
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Jan 2018
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539094
- Sponsor's protocol ID
- 201707010
- Acronym
- IFMS
- Status last verified
- Jan 2024
- First submitted
- 27 Apr 2018
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Ghezzi L, Tosti V, Shi L, Cantoni C, Mikesell R, Lancia S, Zhou Y, Obert K, Dula C, Sen MK, Ge A, Tolentino M, Bollman B, Don AS, Matarese G, Colamatteo A, La Rocca C, Lepore MT, Raji CA, Rahmani F, Wu GF, Naismith RT, Fontana L, Cross AH, Salter A, Piccio L. Randomised controlled trial of intermittent calorie restriction in people with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2025 Jan 16;96(2):158-169. doi: 10.1136/jnnp-2024-333465.
PubMed 39137977
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Intermittent Fasting in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03539094
- Acronym / sponsor ID
- IFMS / 201707010
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Intermittent fasting, western diet, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 29 May 2018 (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.
This is a randomized controlled trial that will test the effects of intermittent fasting (IF) in subjects with relapsing-remitting MS (RRMS). The goal of this clinical trial is to acquire objective evidence regarding whether an IF diet has beneficial effects in MS patients.Two dietary regimens, IF and western diet, will be compared in a randomized, controlled, single-blinded 12 week trial in RRMS patients. This is a single-center study.
Detailed description
RRMS patients will be enrolled in a randomized, controlled, single-blinded 12 week trial in which IF will be compared to a standard western diet. Patients will be recruited at the John L. Trotter MS center and randomly assigned to either a standard western diet or an IF diet (1:1). Enrolled subjects will complete a clinical and laboratory assessment before starting the diet (baseline), at week 6 and at end of the study (week 12). The primary outcome will be leptin at week 12 measured in the peripheral blood. Secondary outcomes will be: 1) peripheral blood metabolic profiling; 2) anthropometric (body mass index and waist circumference) and total body fat measures; 3) gut microbiota richness and composition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting | Experimental | Other: Intermittent fastingThe subjects randomized to this group will do IF by restricting their diet and consuming few calories two days per week. During the days of fasting, subjects will be allowed to drink water, calorie-free beverages, and eat fresh, steamed or roasted non-starchy vegetables. |
| Western diet | No intervention | –The subjects randomized to this group will eat a standard western style diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of RRMS (2010 Mc Donald criteria).
- EDSS <6.0 and disease duration ≤ 15 years.
- On an injectable therapy for MS, glatiramer acetate (GA) or beta-interferon (beta-IFN) for at least 3 months prior to the study and with no anticipated changes of the medication for the 12 week study duration.
- Age ≥18 years.
- BMI > 22 and < 35 kg/m2 with stable weight in the 3 months prior to screening.
Key exclusion criteria (12 listed)
- History of any chronic disease process (excluding MS) that could interfere with interpretation of results.
- Diagnosis in the past of an eating disorder (anorexia, bulimia, or binge eating).
- Relapsing at the time of enrollment.
- On corticosteroid treatment (oral or intravenous) in the past month. Nasal corticosteroid treatments are allowed.
- Diagnosis of diabetes or at time of OGTT (fasting glucose >126 mg/dl or > 200 mg/dl at 2 hours with a load of 75 g of glucose
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 |
|---|---|---|
| Intermittent fastingthe subjects randomized to this group will do IF by restricting their diet and consuming few calories two days per week. During the days of fasting, subjects will be allowed to drink water, calorie-free beverages, and eat fresh, steamed or roasted non-starchy vegetables. | Other | Intermittent fasting |
Primary outcome
Leptin
Time frame: 12 weeks
Leptin at week 12 measured in the peripheral blood
4 secondary outcomes
Peripheral metabolic and inflammatory profiling
Time frame: 12 weeks
Anthropometric measure
Time frame: 12 weeks
Anthropometric measure
Time frame: 12 weeks
Gut microbiota
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Derived from this study: PubMed 39137977Ghezzi L, Tosti V, Shi L, Cantoni C, Mikesell R, Lancia S, Zhou Y, Obert K, Dula C, Sen MK, Ge A, Tolentino M, Bollman B, Don AS, Matarese G, Colamatteo A, La Rocca C, Lepore MT, Raji CA, Rahmani F, Wu GF, Naismith RT, Fontana L, Cross AH, Salter A, Piccio L. Randomised controlled trial of intermittent calorie restriction in people with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2025 Jan 16;96(2):158-169. doi: 10.1136/jnnp-2024-333465.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent fasting in people with Relapsing Remitting Multiple Sclerosis, run by Washington University School of Medicine 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 16 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leptin (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539094, which also lists 1 linked publication.
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 16 Jan 2024.