Nutritional Approaches in Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Nutritional Approaches in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: ketogenic diet
* Behavioral: Intermittent therapeutical fasting
* Behavioral: Active comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Existing health insurance, so that in case of random findings these can also be clarified Patients with relapsed-remitting MS according to the MS diagnostic criteria according to McDonald 2010 Age 18-65 Consent ability and written consent BMI between 19 and 45 kg / m2 EDSS <4.5 Stable immunomodulatory therapy or no immunomodulatory therapy> 6 months before confinement In the last 2 years ≥ 1 relapse or within the last 2 years ≥ 1 new T2 lesions or ≥ 1 contrast-sensitive lesion in MRT Consent that possible random findings are reported Exclusion Criteria: Initiation or modification of immunomodulatory therapy during the study Cortisone treatment in the last 30 days before enrollment Relapse in the last 30 days before enrollment Insulin-dependent diabetes mellitus (type I) Intake of Omega 3 fatty acids (DHA, EPA) - more than 1 g / day Significant cognitive impairment, clinically relevant or progressive disease (e.g., liver, kidney, cardiovascular system, respiratory tract, vascular system, brain, metabolism, thyroid) that could affect the course of the study Malignant disease Simultaneous participation in an interventional study or participation in an interventional study in the last two months before study inclusion Clinically relevant addiction or substance abuse disorder (defined as alcohol, drug and drug abuse) Nicotine consumption of > 5 cigarettes per day and no willingness to stop consumption during therapeutic fasting. Insufficient mental possibility of cooperation Eating disorder Kidney stones Known metabolic disorders (e.g., fatty acid oxidation disorders, ketolysis / ketogenesis or glucogenesis disorder, hyperinsulinism (e.g., nesidioblastoma), pyruvate carboxylase deficiency) Therapy with oral anticoagulants (e.g., Marcumar) Pregnancy and breast feeding period Suspected lack of compliance Performing of a diet for weight reduction Special diet for medical reasons Change of the body weight of more than 5 kg within one month before the start of the Intervention Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study Contraindications to MRT examinations [persons with metallic implants (e.g., intracranial metal clips) and carriers of electronic devices (e.g., pacemaker) or persons with claustrophobia]

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketogenic diet<br> | Behavioral: ketogenic diet<br>* Patients receive a ketogenic diet, which is carbohydrate-reduced with a high amount of fat.<br>|
| Experimental: Intermittent therapeutical fasting<br> | Behavioral: Intermittent therapeutical fasting<br>* 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.<br>|
| Active Comparator: Control group<br>The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients. | Behavioral: Active comparator<br>* The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapse-remitting Multiple Sclerosis