Efficacy of therapeutic fasting and plant-based diet in patients with rheumatoid arthritis (NutriFast): study protocol for a randomised controlled clinical trial
Thomas Häupl,
Anika M Hartmann,
Melanie Dell'Oro,
Christian S Kessler,
Dania Schumann,
Nico Steckhan,
Michael Jeitler,
Jan Moritz Fischer,
Michaela Spoo,
Martin A Kriegel,
Jochen G Schneider,
Farid I Kandil,
Andreas Michalsen,
Daniela A Koppold-Liebscher
Affiliations
Thomas Häupl
1 Department of Rheumatology and Clinical Immunology, Charité University Medicine Berlin, Corporate Member of Free University Berlin, Humboldt University Berlin and Berlin Institute of Health, Berlin, Germany
Anika M Hartmann
Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
Melanie Dell'Oro
Department of Internal and Integrative Medicine, Immanuel Hospital Berlin-Wannsee Branch, Berlin, Germany
Christian S Kessler
Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
Dania Schumann
Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
Nico Steckhan
Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
Michael Jeitler
Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
Jan Moritz Fischer
Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
Michaela Spoo
Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
Martin A Kriegel
Institute for Musculoskeletal Medicine, Department of Translational Rheumatology and Immunology, University of Münster, Münster, Germany
Jochen G Schneider
Department of Internal Medicine II, Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes, Homburg, Germany
Farid I Kandil
Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
Andreas Michalsen
Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
Daniela A Koppold-Liebscher
Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
Background Previous studies have shown beneficial effects of therapeutic fasting and plant-based dietary interventions on disease activity in patients with rheumatoid arthritis (RA) for a duration of up to 1 year. To date, the effects of such interventions on the gut microbiome and on modern diagnostic markers in patients with RA have not been studied. This trial aims to investigate the clinical effects of therapeutic fasting and a plant-based diet in patients with RA, additionally considering current immunological diagnostic tools and microbiome analyses.Methods/design This trial is an open-label, single-centre, randomised, controlled, parallel-group clinical trial. We will randomly assign 84 patients with RA under a stable standard therapy to either (1) therapeutic fasting followed by a plant-based dietary intervention or (2) to a conventional nutritional counselling focusing on an anti-inflammatory dietary pattern according to the recommendations of the Deutsche Gesellschaft für Ernährung (German society for nutrition). Primary outcome parameter is the group difference from baseline to 12 weeks on the Health Assessment Questionnaire (HAQ). Other secondary outcomes include established clinical criteria for disease activity and treatment response in RA (Disease Activity Score 28, Simple Disease Activity Index, ACR-Response Criteria), changes in self-reported health and physical functional ability, mood, stress, quality of life, dietary behaviour via 3-day food records and a modified Food Frequency Questionnaire, body composition, changes in the gut microbiome, metabolomics and cytometric parameters. Outcomes will be assessed at baseline and day 7, after 6 weeks, 12 weeks and after 6 months.Ethics and dissemination Ethical approval to process and analyse data, and to publish the results was obtained through the institutional review board of Charité-Universitätsmedizin Berlin. Results of this trial will be disseminated through peer-reviewed publications and scientific presentations.Trial registration number NCT03856190.
