Nutritional Approaches in Multiple Sclerosis

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 Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: ketogenic diet; Behavioral: Intermittent therapeutical fasting; Behavioral: Active comparator

• Study Type: Interventional
• Enrollment (Anticipated): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketogenic diet	Behavioral: ketogenic diet; Patients receive a ketogenic diet, which is carbohydrate-reduced with a high amount of fat.
Experimental: Intermittent therapeutical fasting	Behavioral: Intermittent therapeutical fasting; 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.
Active Comparator: Control group; The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from baseline at 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Change from baseline at 9 and 18 months
annual relapse rate	relapse rate	12 months
progress of brain atrophy	PBVC = percent brain volume change	Change from baseline at 18 months

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Friedemann Paul, Dr. med., Charite University, Berlin, Germany

Publications and helpful links

General Publications

• Bahr LS, Bock M, Liebscher D, Bellmann-Strobl J, Franz L, Pruss A, Schumann D, Piper SK, Kessler CS, Steckhan N, Michalsen A, Paul F, Mahler A. Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study. Trials. 2020 Jan 2;21(1):3. doi: 10.1186/s13063-019-3928-9.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Relapse-remitting Multiple Sclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: NAMS-study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No