Nutritional Approaches in Multiple Sclerosis

• ClinicalTrials.gov Identifier: NCT03508414
• Recruitment Status: Active, not recruiting
• First Posted: April 25, 2018
• Last Update Posted: July 29, 2021
• Sponsor: Charite University, Berlin, Germany
• Information provided by (Responsible Party): Friedemann Paul, Charite University, Berlin, Germany

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Behavioral: ketogenic diet; Behavioral: Intermittent therapeutical fasting; Behavioral: Active comparator	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Nutritional Approaches in Multiple Sclerosis
• Actual Study Start Date: April 11, 2017
• Estimated Primary Completion Date: December 1, 2021
• Estimated Study Completion Date: December 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in cerebral T2 lesions from Baseline at 18 months [ Time Frame: Change from baseline at 18 months ]
   Number of new cerebral T2 lesions in MRT after 18 months compared to baseline MRT

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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]

Contacts and Locations

Locations

Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany, 10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Friedemann Paul, Principal Investigator, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT03508414
• Other Study ID Numbers: NAMS-study
• First Posted: April 25, 2018
• Last Update Posted: July 29, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Friedemann Paul, Charite University, Berlin, Germany:

Relapse-remitting Multiple Sclerosis

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases