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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
111
Patients receive a ketogenic diet, which is carbohydrate-reduced with a high amount of fat.
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.
The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients.
Charité - Universitätsmedizin Berlin
Berlin, Germany
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
Time frame: Change from baseline at 18 months
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)
Time frame: 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.
Time frame: Change from baseline at 9 and 18 months
annual relapse rate
relapse rate
Time frame: 12 months
progress of brain atrophy
PBVC = percent brain volume change
Time frame: Change from baseline at 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.