A Pilot Trial to Test the Feasibility of Prolonged Fasting and Ketogenic Diet in Relapsing-remitting Multiple Sclerosis

Study Overview
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Brief Summary
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It is well accepted that nutrition as an environmental factor is involved in the pathogenesis of multiple sclerosis. But is there a role for prolonged fasting and ketogenic low glycemic load treatment to alter the course of multiple sclerosis (MS)? The investigators think yes there is. Primarily the investigators want to detect if these diets are feasible for MS patients. Therefore the investigators examine the impact of this dietary intervention on the health related quality of life for individuals after 7 days, 3 months and 6 months in compare to baseline. Secondarily the investigators focus on endocrinological and immunological changes after 7 days, 3 months and 6 months in compare to baseline.

Detailed Description
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In this controlled randomised pilot study the patients are allocated to 1. a ketogenic low glycemic load treatment from the outset of the study for 24 weeks or 2. enhance their regular diet with an initial 7-day fasting followed by a Mediterranean diet pattern until the study end or 3. stay on their regular diet (control group) from the outset of the study for 24 weeks. The investigators will then assess the differences between the groups.

Official Title
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A Randomised Controlled Pilot Study to Compare the Effects of Prolonged Fasting and Ketogenic Low Glycemic Load Treatment on Health Related Quality of Life in Relapsing-remitting Multiple Sclerosis.

Conditions
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Relapsing-Remitting Multiple Sclerosis

Intervention / Treatment
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* Other: Prolonged Fasting
* Other: Ketogenic low glycemic load treatment
* Other: Control diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Relapsing remitting MS Stable immunomodulatory treatment or no treatment at least 6 months prior to inclusion Expanded disability status scale < 7 Body mass index (BMI) > or = 18,5 OR BMI > or = 45 with no risk factors Not pregnant or breast-feeding No serious mental health illness such as dementia or schizophrenia; No use of a weight loss therapy in the month prior to screening. Exclusion Criteria: Start or changes if immunomodulatory treatment < 7 months prior to screening SPMS or PPMS Relapse or corticosteroid use < 30 days prior to screening Diabetes or any metabolic defects Bulimia Anorexia Drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged fasting<br>Patients undergo an initial 7-day fasting episode. | Other: Prolonged Fasting<br>* Patients enhance their regular diet with an initial 7-day fasting episode.<br>|
| Experimental: Ketogenic low glycemic load treatment<br>Patients receive a ketogenic low glycemic load treatment from the outset of the study. | Other: Ketogenic low glycemic load treatment<br>* 6 months of ketogenic low glycemic load treatment from the study outset.<br>|
| Experimental: Control diet<br>Patients stay on their regular diet. | Other: Control diet<br>* Patients stay on their regular diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Multiple Sclerosis Quality of Life-54 questionnaire: Proof of feasibility at 6 months. | Two summary scores: physical health und mental health, 12 subscales and 2 single item scales. | Visit: Baseline, month 1, month 3 and month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rates, number of participants with adverse events and laboratory parameters at 6 months. | Multiple sclerosis functional composite; fatigue scores, body composition; body weight; lipid profile, liver enzymes, insulin, glucagon | Visits: Baseline, month 1, month 3 and month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, diet, prolonged fasting, caloric restriction, ketogenic low glycemic load treatment, health related quality of life, ketogenic diet, neurodegeneration, neuroinflammation