Ketogenic diet as a complementary therapy for myasthenia gravis - a randomized controlled trial

Not Applicable

Recruiting

• Conditions: G70.0; Myasthenia gravis

• Registration Number: DRKS00032686
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 84

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- Reduction in laboratory chemical disease activity parameters (calpotectin, serum neurofilament light chain) in the intervention group after 12 weeks of intervention<br>- Upregulation of regulatory T cells in the intervention group after 12 weeks of intervention<br>- Reduction in clinical symptom severity parameter (QMG score) in the intervention group after 12 weeks of intervention<br>- 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