To eat or not to eat-an exploratory randomized controlled trial on fasting and plant-based diet in rheumatoid arthritis (NutriFast-Study)

Anika M Hartmann; Melanie Dell'Oro; Michaela Spoo; Jan Moritz Fischer; Nico Steckhan; Michael Jeitler; Thomas Häupl; Farid I Kandil; Andreas Michalsen; Daniela A Koppold-Liebscher; Christian S Kessler

doi:10.3389/fnut.2022.1030380

To eat or not to eat-an exploratory randomized controlled trial on fasting and plant-based diet in rheumatoid arthritis (NutriFast-Study)

Front Nutr. 2022 Nov 2:9:1030380. doi: 10.3389/fnut.2022.1030380. eCollection 2022.

Authors

Anika M Hartmann^{1

2}, Melanie Dell'Oro², Michaela Spoo^{2

3}, Jan Moritz Fischer², Nico Steckhan^{2

4}, Michael Jeitler^{2

3}, Thomas Häupl^{2

5}, Farid I Kandil^{2

6}, Andreas Michalsen^{2

3}, Daniela A Koppold-Liebscher^{2

3}, Christian S Kessler^{2

3}

Affiliations

¹ Department of Dermatology, Venereology and Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
² Institute for Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
³ Department of Internal and Integrative Medicine, Immanuel Hospital Berlin, Berlin, Germany.
⁴ Connected Healthcare, Hasso Plattner Institute, University of Potsdam, Potsdam, Germany.
⁵ Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
⁶ Department of Paediatric Oncology/Haematology, Otto-Heubner Centre for Paediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.

Abstract

Background: Fasting is beneficial in many diseases, including rheumatoid arthritis (RA), with lasting effects for up to 1 year. However, existing data dates back several decades before the introduction of modern therapeutic modalities.

Objective: This exploratory RCT compares the effects of a 7-day fast followed by a plant-based diet (PBD) to the effects of the dietary recommendations of the German society for nutrition (Deutsche Gesellschaft für Ernährung, DGE) on RA disease activity, cardiovascular (CV) risk factors, and well-being.

Methods: In this RCT we randomly assigned 53 RA patients to either a 7-day fast followed by an 11-week PBD or a 12-week standard DGE diet. The primary endpoint was the group change from baseline to 12 weeks on the Health Assessment Questionnaire Disability Index (HAQ-DI). Further outcomes included other disease activity scores, body composition, and quality of life.

Results: Of 53 RA patients enrolled, 50 participants (25 per group) completed the trial and were included into the per-protocol analysis. The primary endpoint was not statistically significant. However, HAQ-DI improved rapidly in the fasting group by day 7 and remained stable over 12 weeks (Δ-0.29, p = 0.001), while the DGE group improved later at 6 and 12 weeks (Δ-0.23, p = 0.032). DAS28 ameliorated in both groups by week 12 (Δ-0.97, p < 0.001 and Δ-1.14, p < 0.001; respectively), with 9 patients in the fasting but only 3 in the DGE group achieving ACR50 or higher. CV risk factors including weight improved stronger in the fasting group than in the DGE group (Δ-3.9 kg, p < 0.001 and Δ-0.7 kg, p = 0.146).

Conclusions: Compared with a guideline-based anti-inflammatory diet, fasting followed by a plant-based diet showed no benefit in terms of function and disability after 12 weeks. Both dietary approaches had a positive effect on RA disease activity and cardiovascular risk factors in patients with RA.

Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT03856190, identifier: NCT03856190.

Keywords: caloric restriction; fasting; inflammation; plant-based diet; rheumatoid arthritis.

Associated data

ClinicalTrials.gov/NCT03856190