Nutritional Approaches in Multiple Sclerosis

NCT ID: NCT03508414

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-11
• Study Completion Date: 2021-12-01

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ketogenic diet

Group Type: EXPERIMENTAL

ketogenic diet

Intervention Type: BEHAVIORAL

Patients receive a ketogenic diet, which is carbohydrate-reduced with a high amount of fat.

Intermittent therapeutical fasting

Group Type: EXPERIMENTAL

Intermittent therapeutical fasting

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Active comparator

Intervention Type: BEHAVIORAL

The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients.

Interventions

ketogenic diet

Patients receive a ketogenic diet, which is carbohydrate-reduced with a high amount of fat.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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]

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Friedemann Paul

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Friedemann Paul, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 31898518 (View on PubMed)

Other Identifiers

NAMS-study

Identifier Type: -

Identifier Source: org_study_id