Nutritional Approaches in Multiple Sclerosis

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: ketogenic diet; Behavioral: Active comparator; Behavioral: Intermittent therapeutical fasting

• Registration Number: NCT03508414
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-11
• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-04-25
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 111

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]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Ketogenic diet	ketogenic diet	-
Control group	Active comparator	The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients.
Intermittent therapeutical fasting	Intermittent therapeutical fasting	-

Primary Outcome Measures

Name	Time	Method
Change in cerebral T2 lesions from Baseline at 18 months	Change from baseline at 18 months	Number of new cerebral T2 lesions in MRT after 18 months compared to baseline MRT

Secondary Outcome Measures

Name	Time	Method
Change in neurological-functional disability: physical and cognitive function	Change from baseline at 9 and 18 months	influence of the interventions on cognitive and physical disability progression using Multiple Sclerosis Functional Composite (MSFC)
progress of brain atrophy	Change from baseline at 18 months	PBVC = percent brain volume change
Change in neurological-functional disability : physical function	Change from baseline at 9 and 18 months	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.
annual relapse rate	12 months	relapse rate

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany