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
Christensen R, Heitmann BL, Andersen KW, Nielsen OH, Sørensen SB, Jawhara M, Bygum A, Hvid L, Grauslund J, Wied J, Glerup H, Fredberg U, Villadsen JA, Kjær SG, Fallingborg J, Moghadd SAGR, Knudsen T, Brodersen J, Frøjk J, Dahlerup JF, Bojesen AB, Sorensen GL, Thiel S, Færgeman NJ, Brandslund I, Bennike TB, Stensballe A, Schmidt EB, Franke A, Ellinghaus D, Rosenstiel P, Raes J, Boye M, Werner L, Nielsen CL, Munk HL, Nexøe AB, Ellingsen T, Holmskov U, Kjeldsen J, Andersen V
BMJ open · 21 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Cohort study (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
- Intake measured by
- Not stated
Who paid for it
- Funding
- Independent funding
- Government
- Region Syddanmark
- Nonprofit
- Oak Foundation
- Nonprofit
- Villum Fonden
- Nonprofit
- Parker Institute for Cancer Immunotherapy
- Government
- European Commission
- University or hospital
- Syddansk Universitet
- Nonprofit
- Knud og Edith Eriksens Mindefond
- Government
- H2020 European Research Council
- University or hospital
- Odense Patient data Explorative Network
- Government
- European Research Council
- Government
- Region of Southern Denmark
- Grants
- European Commission (733100); Villum Fonden (00007292)
Based on 11 listed funder(s).
Publication
- Published
- 2018-02-01 · BMJ Open · vol. 8 · issue 2 · p. e018166
- Publisher
- BMJ
- Cited
- 24 citations · more than 88% of similar papers · 2.3× the field average
- References
- 125 works
- Access
- Open access (journal) · CC-BY-NC
- Research areas
- Inflammatory Bowel Disease · Hidradenitis Suppurativa and Treatments · Microscopic Colitis
- Keywords
- Medicine, Psoriatic arthritis, Prospective cohort study, Internal medicine, Psoriasis, Inflammatory bowel disease, Rheumatoid arthritis, Ulcerative colitis, Disease, Physical therapy, Cohort, Cohort study, Immunology
- MeSH
- humans, rheumatic diseases, inflammatory bowel diseases, uveitis, skin diseases, chronic disease, inflammation, tumor necrosis factor-alpha, prognosis, diet, prospective studies, life style, research design, quality of life, dietary fiber, meat products, precision medicine, red meat, patient reported outcome measures
41 authors
From DK, DE, BE, GB
- Robin ChristensenFrederiksberg Hospital
- Berit L. HeitmannUniversity of Copenhagen; University of Southern Denmark; Frederiksberg Hospital
- Karina Winther AndersenSygehus Sønderjylland
- Ole Haagen NielsenUniversity of Copenhagen; Herlev Hospital
- Signe Bek SørensenUniversity of Southern Denmark; Sygehus Sønderjylland
- Mohamad JawharaUniversity of Southern Denmark; Sygehus Sønderjylland
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.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC).
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