G70.0
Conditions
Interventions
Group 1: Patients with myasthenia gravis receiving a ketogenic diet for 12 weeks (intervention group)
- 3 visits (baseline, week 6, week 12) with collection of quality of life questionnaires, physica
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Patient capable of giving consent - Diagnosis of myasthenia gravis - Written consent to participate - Body mass index 19-45 kg/m2 - Age 18-65 years - Stable immunomodulatory therapy or no immunomodulatory therapy > 3 months prior to study entry
Exclusion criteria
Exclusion criteria: - Clinically relevant underlying metabolic or malignant disease - Insulin-dependent diabetes mellitus type I - Participation in another intervention study - Eating disorder - Kidney stones - Therapy with oral anticoagulants - Pregnancy or breastfeeding - Assumed lack of compliance - Known alcohol or drug abuse - anticoagulant medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the MG-ADL score (myasthenia-specific quality of life scores) in the intervention group by >/= 2 points after 12 weeks of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| - Reduction in laboratory chemical disease activity parameters (calpotectin, serum neurofilament light chain) in the intervention group after 12 weeks of intervention - Upregulation of regulatory T cells in the intervention group after 12 weeks of intervention - Reduction in clinical symptom severity parameter (QMG score) in the intervention group after 12 weeks of intervention - Improvement in quality of life measured by MG-Qol score (myasthenia-specific quality of life score), PASS (Patient Acceptable Symptom State) and FSS (Fatigue Severity Scale) in the intervention group after 12 weeks of intervention | — |
Countries
Germany
Contacts
Public ContactFrauke Stascheit
Charité - Universitätsmedizin Berlin
Outcome results
None listed