Nutritional Approaches in Multiple Sclerosis

NCT03508414 | Unknown DMC

• 1 other identifier: NAMS-study
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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

Keywords

Relapse-remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in neurological-functional disability: physical and cognitive function

  Change from baseline at 9 and 18 months

• Change in neurological-functional disability : physical function

  Change from baseline at 9 and 18 months

• annual relapse rate

  12 months

• progress of brain atrophy

  Change from baseline at 18 months

Study Arms (3)

Ketogenic diet

EXPERIMENTAL

Behavioral: ketogenic diet

Intermittent therapeutical fasting

EXPERIMENTAL

Behavioral: Intermittent therapeutical fasting

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.

Behavioral: Active comparator

Interventions

ketogenic diet BEHAVIORAL

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

Ketogenic diet

Intermittent therapeutical fasting 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.

Intermittent therapeutical fasting

Active comparator 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.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

• 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.

  PMID: 31898518 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Friedemann Paul, Dr. med.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: April 25, 2018
• Study Start: April 11, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)