Aarhus University Seal / Aarhus Universitets segl

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

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaperJournal articleResearchpeer-review

  • Robin Christensen, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark. Robin.Christensen@regionh.dk.
  • ,
  • Berit L Heitmann, Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Part of the Copenhagen University Hospital, 2000 Frederiksberg, Denmark. Berit.Lilienthal.Heitmann@regionh.dk., Department of Public Health, Section for General Medicine, University of Copenhagen, 1353 Copenhagen, Denmark. Berit.Lilienthal.Heitmann@regionh.dk., 2 National Institute of Public Health, University of Southern Denmark, Odense, Denmark.
  • ,
  • Karina Winther Andersen, 1] Medical Department, Viborg Regional Hospital, Viborg, Denmark [2] Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark [3] Organ Centre, Hospital of Southern Jutland Aabenraa, Aabenraa, Denmark [4] OPEN Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark.
  • ,
  • Ole Haagen Nielsen, Department of Gastroenterology D112, Herlev Hospital, University of Copenhagen, 2730 Herlev, Denmark. Ole.Haagen.Nielsen@regionh.dk.
  • ,
  • Signe Bek Sørensen, Focused Research Unit for Molecular Diagnostic and Clinical Research, IRS-Center Sonderjylland, Hospital of Southern Jutland, 6200 Aabenraa, Denmark. vandersen@health.sdu.dk., University of Southern Denmark
  • ,
  • Mohamad Jawhara, Faculty of Health Sciences, Institute of Regional Health Services Research, University of Southern Denmark, Odense, Denmark.
  • ,
  • Anette Bygum, University of Southern Denmark
  • ,
  • Lone Hvid, University of Southern Denmark
  • ,
  • Jakob Grauslund, Department of Oncology, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark , Department of Ophthalmology, Odense University Hospital, 5000 Odense, Denmark. Jakob.Grauslund@rsyd.dk.
  • ,
  • Jimmi Wied, Department of Ophthalmology, Odense University Hospital, 5000 Odense, Denmark. Jakob.Grauslund@rsyd.dk.
  • ,
  • Henning Glerup
  • ,
  • Ulrich Fredberg
  • Jan Alexander Villadsen
  • ,
  • Søren Geill Kjær
  • ,
  • Jan Fallingborg, Department of Gastroenterology and Hepatology, Aalborg University Hospital
  • ,
  • Seyed A G R Moghadd, Department of Internal Medicine, Regional Hospital Herning, 7400 Herning, Denmark. seyeghan@rm.dk.
  • ,
  • Torben Knudsen, Department of Gastroenterology, Hospital of Southwest Jutland, Esbjerg, Denmark.
  • ,
  • Jacob Brodersen, Department of Gastroenterology, Hospital of Southwest Jutland, Esbjerg, Denmark.
  • ,
  • Jesper Frøjk, Department of Gastroenterology, Hospital of Southwest Jutland, Esbjerg, Denmark.
  • ,
  • Jens Frederik Dahlerup
  • Anders Bo Bojesen, Focused Research Unit for Molecular Diagnostic and Clinical Research, IRS-Center Sonderjylland, Hospital of Southern Jutland, 6200 Aabenraa, Denmark. vandersen@health.sdu.dk.
  • ,
  • Grith Lykke Sorensen, University of Southern Denmark
  • ,
  • Steffen Thiel
  • Nils J Færgeman, Department of Biochemistry and Molecular Biology, Villum Center for Bioanalytical Sciences, University of Southern Denmark, 5000 Odense, Denmark. Nils.F@bmb.sdu.dk.
  • ,
  • Ivan Brandslund, Department of Clinical Immunology and Biochemistry, Lillebaelt Hospital, Vejle, Denmark.
  • ,
  • Tue Bjerg Bennike, Aalborg University
  • ,
  • Allan Stensballe
  • Erik Berg Schmidt, Aalborg University
  • ,
  • Andre Franke, Institute of Clinical Molecular Biology, Christian-Albrechts-University, Kiel, Germany.
  • ,
  • David Ellinghaus, Institute of Clinical Molecular Biology, Christian-Albrechts-University, Kiel, Germany.
  • ,
  • Philip Rosenstiel, Institute of Clinical Molecular Biology, Christian-Albrechts-University, Kiel, Germany.
  • ,
  • Jeroen Raes, VIB, Center for the Biology of Disease, Leuven, Belgium.
  • ,
  • Mette Boye, Focused Research Unit for Molecular Diagnostic and Clinical Research, IRS-Center Sonderjylland, Hospital of Southern Jutland, 6200 Aabenraa, Denmark. vandersen@health.sdu.dk.
  • ,
  • Lars Werner, The Danish Psoriasis Association, 2630 Tåstrup, Denmark. lw@psoriasis.dk.
  • ,
  • Charlotte Lindgaard Nielsen, The Danish Colitis-Crohn Association, 5000 Odense, Denmark. info@ccf.dk.
  • ,
  • Heidi Lausten Munk, e Department of Rheumatology , Odense University Hospital , Odense , Denmark.
  • ,
  • Anders Bathum Nexøe, Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark.
  • ,
  • Torkell Ellingsen, e Department of Rheumatology , Odense University Hospital , Odense , Denmark.
  • ,
  • Uffe Holmskov, University of Southern Denmark
  • ,
  • Jens Kjeldsen, Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark.
  • ,
  • Vibeke Andersen, Focused Research Unit for Molecular Diagnostic and Clinical Research, IRS-Center Sonderjylland, Hospital of Southern Jutland, 6200 Aabenraa, Denmark. vandersen@health.sdu.dk., University of Southern Denmark, Faculty of Health Sciences, Institute of Regional Health Services Research, University of Southern Denmark, Odense, Denmark., c OPEN, Odense Patient data Explorative Network , Odense University Hospital/Institute of Clinical Research, University of Southern Denmark , Odense , Denmark.

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.

Original languageEnglish
Article numbere018166
JournalBMJ Open
Volume8
Issue2
Number of pages15
ISSN2044-6055
DOIs
Publication statusPublished - 8 Feb 2018

    Research areas

  • biomarker and lifestyle, lifestyle and chronic inflammatory disease, patient related outcome measures, personalized medicine, treatment outcome, western style diet, LONG-TERM INTAKE, RHEUMATOID-ARTHRITIS, EUROPEAN PROSPECTIVE COHORT, CROHNS-DISEASE, ULCERATIVE-COLITIS, ANKYLOSING-SPONDYLITIS, SHORT HEALTH SCALE, BOWEL-DISEASE, FOOD FREQUENCY QUESTIONNAIRE, SULFATE-REDUCING BACTERIA

See relations at Aarhus University Citationformats

ID: 123735706