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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Western diet | No Intervention | The subjects randomized to this group will eat a standard western style diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent fasting | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Leptin | Leptin at week 12 measured in the peripheral blood | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral metabolic and inflammatory profiling | Adipokine and inflammatory markers at week 12 measured in the peripheral blood | 12 weeks |
| Anthropometric measure | Weight and height will be combined to report BMI in kg/mg^2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St Louis | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39137977 | Derived | 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. |
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IPD will not be shared with other researchers.
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Randomized controlled clinical trial
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Outcome assessors will be blinded to the intervention because they will not know the group assignment.
|
| 12 weeks |
| Anthropometric measure | Waist circumference in centimeters | 12 weeks |
| Gut microbiota | Gut microbiota richness and composition | 12 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |