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

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...

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Autores principales: Bahr, Lina Samira, Bock, Markus, Liebscher, Daniela, Bellmann-Strobl, Judith, Franz, Liane, Prüß, Alexandra, Schumann, Dania, Piper, Sophie K., Kessler, Christian S., Steckhan, Nico, Michalsen, Andreas, Paul, Friedemann, Mähler, Anja
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6941322/
https://www.ncbi.nlm.nih.gov/pubmed/31898518
http://dx.doi.org/10.1186/s13063-019-3928-9
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author Bahr, Lina Samira
Bock, Markus
Liebscher, Daniela
Bellmann-Strobl, Judith
Franz, Liane
Prüß, Alexandra
Schumann, Dania
Piper, Sophie K.
Kessler, Christian S.
Steckhan, Nico
Michalsen, Andreas
Paul, Friedemann
Mähler, Anja
author_facet Bahr, Lina Samira
Bock, Markus
Liebscher, Daniela
Bellmann-Strobl, Judith
Franz, Liane
Prüß, Alexandra
Schumann, Dania
Piper, Sophie K.
Kessler, Christian S.
Steckhan, Nico
Michalsen, Andreas
Paul, Friedemann
Mähler, Anja
author_sort Bahr, Lina Samira
collection PubMed
description 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.
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spelling pubmed-69413222020-01-06 Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study Bahr, Lina Samira Bock, Markus Liebscher, Daniela Bellmann-Strobl, Judith Franz, Liane Prüß, Alexandra Schumann, Dania Piper, Sophie K. Kessler, Christian S. Steckhan, Nico Michalsen, Andreas Paul, Friedemann Mähler, Anja Trials Study Protocol 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. BioMed Central 2020-01-02 /pmc/articles/PMC6941322/ /pubmed/31898518 http://dx.doi.org/10.1186/s13063-019-3928-9 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Bahr, Lina Samira
Bock, Markus
Liebscher, Daniela
Bellmann-Strobl, Judith
Franz, Liane
Prüß, Alexandra
Schumann, Dania
Piper, Sophie K.
Kessler, Christian S.
Steckhan, Nico
Michalsen, Andreas
Paul, Friedemann
Mähler, Anja
Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study
title Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study
title_full Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study
title_fullStr Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study
title_full_unstemmed Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study
title_short Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study
title_sort ketogenic diet and fasting diet as nutritional approaches in multiple sclerosis (nams): protocol of a randomized controlled study
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6941322/
https://www.ncbi.nlm.nih.gov/pubmed/31898518
http://dx.doi.org/10.1186/s13063-019-3928-9
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