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The aim of this project is to characterize the influence of a ketogenic diet and intermittent therapeutical fasting on the course of the disease, as measured by T2-hyperintense cerebral lesions with magnetic resonance tomography (MRT) in patients with multiple sclerosis (RRMS). The investigators expect in both intervention groups fewer cerebral T2 lesions occurring after 18 months in comparison to the control group and as detectable by MRT. According to current recommendations of the German Society of Nutrition (DGE), the control group receives a vegetarian-focused, anti-inflammatory diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic diet | Experimental |
| |
| Intermittent therapeutical fasting | Experimental |
| |
| Control group | Active Comparator | The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketogenic diet | Behavioral | Patients receive a ketogenic diet, which is carbohydrate-reduced with a high amount of fat. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cerebral T2 lesions from Baseline at 18 months | Number of new cerebral T2 lesions in MRT after 18 months compared to baseline MRT | Change from baseline at 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in neurological-functional disability: physical and cognitive function | influence of the interventions on cognitive and physical disability progression using Multiple Sclerosis Functional Composite (MSFC) | Change from baseline at 9 and 18 months |
| Change in neurological-functional disability : physical function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Friedemann Paul, Dr. med. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40836308 | Derived | Bahr LS, Bellmann-Strobl J, Koppold DA, Rust R, Schmitz-Hubsch T, Olszewska M, Stadlbauer J, Bock M, Scheel M, Chien C, Multmeier J, Krannich A, Michalsen A, Paul F, Mahler A. Fasting, ketogenic, and anti-inflammatory diets in multiple sclerosis: a randomized controlled trial with 18-month follow-up. BMC Nutr. 2025 Aug 20;11(1):167. doi: 10.1186/s40795-025-01156-5. | |
| 31898518 |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| 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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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Intermittent therapeutical fasting | Behavioral | Patients fast for 1 week every six months. Additionally, the patients do an intermittent fasting, that is to say they do not eat for at least 14 hours a day. |
|
| Active comparator | Behavioral | The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients. |
|
influence of the interventions on physical disability progression using Expanded Disability Status Score (EDSS). The EDSS is assessing the progress of disability in MS patients with a scale between 0-12 points, while 0 indicates no disability and 10 indicates death through MS. |
| Change from baseline at 9 and 18 months |
| annual relapse rate | relapse rate | 12 months |
| progress of brain atrophy | PBVC = percent brain volume change | Change from baseline at 18 months |
| Bahr LS, Bock M, Liebscher D, Bellmann-Strobl J, Franz L, Pruss A, Schumann D, Piper SK, Kessler CS, Steckhan N, Michalsen A, Paul F, Mahler A. Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study. Trials. 2020 Jan 2;21(1):3. doi: 10.1186/s13063-019-3928-9. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |