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  • Impact of red and processed meat and fibre intake on treatment outcomes among patients with chronic inflammatory diseases: protocol for a prospective cohort study of prognostic factors and personalised medicine

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Medical management
Protocol
Impact of red and processed meat and fibre intake on treatment outcomes among patients with chronic inflammatory diseases: protocol for a prospective cohort study of prognostic factors and personalised medicine
  1. Robin Christensen1,
  2. Berit L Heitmann2,3,4,
  3. Karina Winther Andersen5,6,
  4. Ole Haagen Nielsen7,
  5. Signe Bek Sørensen5,8,
  6. Mohamad Jawhara5,6,9,
  7. Anette Bygum10,
  8. Lone Hvid10,
  9. Jakob Grauslund11,12,
  10. Jimmi Wied11,12,
  11. Henning Glerup13,
  12. Ulrich Fredberg13,14,
  13. Jan Alexander Villadsen13,
  14. Søren Geill Kjær13,
  15. Jan Fallingborg15,
  16. Seyed A G R Moghadd16,
  17. Torben Knudsen17,
  18. Jacob Brodersen17,
  19. Jesper Frøjk17,
  20. Jens Frederik Dahlerup18,
  21. Anders Bo Bojesen5,
  22. Grith Lykke Sorensen8,
  23. Steffen Thiel19,
  24. Nils J Færgeman20,
  25. Ivan Brandslund9,21,
  26. Tue Bjerg Bennike22,
  27. Allan Stensballe22,
  28. Erik Berg Schmidt23,
  29. Andre Franke24,
  30. David Ellinghaus25,
  31. Philip Rosenstiel25,
  32. Jeroen Raes26,27,
  33. Mette Boye5,
  34. Lars Werner28,
  35. Charlotte Lindgaard Nielsen29,
  36. Heidi Lausten Munk13,14,
  37. Anders Bathum Nexøe30,
  38. Torkell Ellingsen13,14,
  39. Uffe Holmskov8,
  40. Jens Kjeldsen30,
  41. Vibeke Andersen5,8,9,31
  1. 1 Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Denmark
  2. 2 Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Denmark
  3. 3 Section for General Medicine, Department of Public Health, University of Copenhagen, Denmark
  4. 4 National Institute of Public Health, University of Southern Denmark, Odense, Denmark
  5. 5 Focused Research Unit for Molecular Diagnostic and Clinical Research, IRS-Center Sonderjylland, Hospital of Southern Jutland, Aabenraa, Denmark
  6. 6 Organ Centre, Hospital of Southern Jutland, Aabenraa, Denmark
  7. 7 Department of Gastroenterology D112, Herlev Hospital, University of Copenhagen, Herlev, Denmark
  8. 8 Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark
  9. 9 institute of Regional Health Research, University of Southern Denmark, Odense, Denmark
  10. 10 Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark
  11. 11 Department of Clinical Research, University of Southern Denmark, Odense, Denmark
  12. 12 Department of Ophthalmology, Odense University Hospital, Odense, Denmark
  13. 13 Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark
  14. 14 Department of Rheumatology, Odense University Hospital, Odense, Denmark
  15. 15 Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark
  16. 16 Department of Internal Medicine, Herning Regional Hospital, Herning, Denmark
  17. 17 Department of Gastroenterology, Hospital of Southwest Jutland, Esbjerg, Denmark
  18. 18 Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark
  19. 19 Department of Biomedicine, Aarhus University, Aarhus, Denmark
  20. 20 Department of Biochemistry and Molecular Biology, Villum Center for Bioanalytical Sciences, University of Southern Denmark, Odense, Denmark
  21. 21 Department of Clinical Biochemistry, Lillebaelt Hospital, Vejle, Denmark
  22. 22 Department of Health Science and Technology, Aalborg University, Aalborg, Denmark
  23. 23 Department of Cardiology, Aalborg University Hospital, Ålborg, Denmark
  24. 24 Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany
  25. 25 Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany
  26. 26 Departmentof Microbiology and Immunology, Rega Institute, KU Leuven—University of Leuven, Leuven, Belgium
  27. 27 VIB, Center for the Biology of Disease, Leuven, Belgium
  28. 28 The Danish Psoriasis Association, The Danish Psoriasis Association, Tåstrup, Denmark
  29. 29 The Danish Colitis‐Crohn Association, The Danish Colitis‐Crohn Association, Odense, Denmark
  30. 30 Department of Gastroenterology, Odense University Hospital, Odense, Denmark
  31. 31 OPEN, University of Southern Denmark, Odense, Denmark
  1. Correspondence to Profosser Vibeke Andersen; vandersen{at}health.sdu.dk, vibeke.andersen1{at}rsyd.dk

Abstract

Introduction Chronic inflammatory diseases (CIDs) are frequently treated with biological medications, specifically tumour necrosis factor inhibitors (TNFi)). These medications inhibit the pro-inflammatory molecule TNF alpha, which has been strongly implicated in the aetiology of these diseases. Up to one-third of patients do not, however, respond to biologics, and lifestyle factors are assumed to affect treatment outcomes. Little is known about the effects of dietary lifestyle as a prognostic factor that may enable personalised medicine. The primary outcome of this multidisciplinary collaborative study will be to identify dietary lifestyle factors that support optimal treatment outcomes.

Methods and analysis This prospective cohort study will enrol 320 patients with CID who are prescribed a TNFi between June 2017 and March 2019. Included among the patients with CID will be patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis), rheumatic disorders (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis. At baseline (pretreatment), patient characteristics will be assessed using patient-reported outcome measures, clinical assessments of disease activity, quality of life and lifestyle, in addition to registry data on comorbidity and concomitant medication(s). In accordance with current Danish standards, follow-up will be conducted 14–16 weeks after treatment initiation. For each disease, evaluation of successful treatment response will be based on established primary and secondary endpoints, including disease-specific core outcome sets. The major outcome of the analyses will be to detect variability in treatment effectiveness between patients with different lifestyle characteristics.

Ethics and dissemination The principle goal of this project is to improve the quality of life of patients suffering from CID by providing evidence to support dietary and other lifestyle recommendations that may improve clinical outcomes. The study is approved by the Ethics Committee (S-20160124) and the Danish Data Protecting Agency (2008-58-035). Study findings will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.

Trial registration number NCT03173144; Pre-results.

  • lifestyle and chronic inflammatory disease
  • biomarker and lifestyle
  • personalized medicine
  • patient related outcome measures
  • treatment outcome
  • western style diet

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-018166

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    Footnotes

    • Contributors VA, BLH and RC wrote the first draft. All other authors, KWA, OHN, SBS, MJ, AB, LH, JG, JW, HG, UF, JAV, SGK, JF, SAGRM, TK, JB, JF, JFD, ABB, GLS, ST, NJF, IB, TBB, AS, EBS, AF, DE, PR, JR, MB, LW, CLN, HLM, ABN, TK, JK and UH contributed to the conception and design of the study. All authors accepted the final submitted version.

    • Funding This project is part of a project that has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement No 733100” (P Rosenstiel, A Franke, J Raes, V Andersen). Funding has furthermore been received from Odense Patient data Explorative Network (OPEN) (OP-332, V Andersen), “Knudog Edith Eriksen’s Mindefond” (V Andersen), Region of Southern Denmark (V Andersen), University of Southern Denmark (V Andersen, U Holmskov). The Parker Institute, Bispebjerg and Frederiksberg Hospital (R Christensen, B L Heitmann) are supported by a core grant from the Oak Foundation (OCAY-13-309).

    • Competing interests All authors declare no conflict of interest. However, the following authors declare: B. Heitmann has received funding from ‘MatPrat’, the information office for Norwegian egg and meat; L. Hvid is on the advisory board for Abbvie A/S; J. Fallingborg is on the advisory boards for AbbVie A/S, MSD Denmark, Takeda Pharma A/S, and Ferring Pharmaceuticals A/S; V. Andersen receives compensation for consultancy and for being a member of the advisory board for MSD Denmark (Merck) and Janssen A/S. The funding sponsors had no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

    • Patient consent Not required.

    • Ethics approval Written informed consent will be obtained from participants before participation in the study. The project has been approved by The Regional Scientific Ethical Committee (S-20160124) and the Danish Data Protection Agency (2008-58-035). The procedures followed are in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975 with later amendments.

    • Provenance and peer review Not commissioned; externally peer reviewed.