Format

Send to

Choose Destination
Trials. 2020 Jan 2;21(1):3. doi: 10.1186/s13063-019-3928-9.

Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study.

Author information

1
NeuroCure Clinical Research Center and Department of Neurology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt Universität Berlin, Berlin, Germany.
2
Institute of Biochemistry, University Medicine Berlin-Charité, Charitéplatz 1, D-10117, Berlin, Germany.
3
Department of Medicine B, Ruppin General Hospital, Brandenburg Medical School, 16816, Neuruppin, Germany.
4
Department of Hand Surgery, Upper Extremity and Foot Surgery, Center for Orthopedics and Trauma Surgery, Hospital Waldfriede, Argentinische Allee 40, 14163, Berlin, Germany.
5
Institute of Social Medicine, Epidemiology & Health Economics, Charité-Universitätsmedizin Berlin, Berlin, Germany.
6
Experimental and Clinical Research Center, a cooperation between Charité-Universitätsmedizin Berlin and Max Delbruck Center for Molecular Medicine, Berlin, Germany.
7
Berlin Institute of Health, Berlin, Germany.
8
Institute of Biometry and Clinical Epidemiology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, D-10117, Berlin, Germany.
9
Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin, Berlin, Germany.
10
Experimental and Clinical Research Center, a cooperation between Charité-Universitätsmedizin Berlin and Max Delbruck Center for Molecular Medicine, Berlin, Germany. anja.maehler@charite.de.
11
Berlin Institute of Health, Berlin, Germany. anja.maehler@charite.de.
12
DZHK (German Centre for Cardiovascular Research), Berlin, Germany. anja.maehler@charite.de.

Abstract

BACKGROUND:

Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system in young adults that may lead to progressive disability. Since pharmacological treatments may have substantial side effects, there is a need for complementary treatment options such as specific dietary approaches. Ketone bodies that are produced during fasting diets (FDs) and ketogenic diets (KDs) are an alternative and presumably more efficient energy source for the brain. Studies on mice with experimental autoimmune encephalomyelitis showed beneficial effects of KDs and FDs on disease progression, disability, cognition and inflammatory markers. However, clinical evidence on these diets is scarce. In the clinical study protocol presented here, we investigate whether a KD and a FD are superior to a standard diet (SD) in terms of therapeutic effects and disease progression.

METHODS:

This study is a single-center, randomized, controlled, parallel-group study. One hundred and eleven patients with relapsing-remitting MS with current disease activity and stable immunomodulatory therapy or no disease-modifying therapy will be randomized to one of three 18-month dietary interventions: a KD with a restricted carbohydrate intake of 20-40 g/day; a FD with a 7-day fast every 6 months and 14-h daily intermittent fasting in between; and a fat-modified SD as recommended by the German Nutrition Society. The primary outcome measure is the number of new T2-weighted MRI lesions after 18 months. Secondary endpoints are safety, changes in relapse rate, disability progression, fatigue, depression, cognition, quality of life, changes of gut microbiome as well as markers of inflammation, oxidative stress and autophagy. Safety and feasibility will also be assessed.

DISCUSSION:

Preclinical data suggest that a KD and a FD may modulate immunity, reduce disease severity and promote remyelination in the mouse model of MS. However, clinical evidence is lacking. This study is the first clinical study investigating the effects of a KD and a FD on disease progression of MS.

TRIAL REGISTRATION:

ClinicalTrials.gov, NCT03508414. Retrospectively registered on 25 April 2018.

KEYWORDS:

Anti-inflammatory diet; Dietary intervention; Intermittent fasting; Ketogenic diet; Multiple sclerosis

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center