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

Robin Christensen; Berit L Heitmann; Karina Winther Andersen; Ole Haagen Nielsen; Signe Bek Sørensen; Mohamad Jawhara; Anette Bygum; Lone Hvid; Jakob Grauslund; Jimmi Wied; Henning Glerup; Ulrich Fredberg; Jan Alexander Villadsen; Søren Geill Kjær; Jan Fallingborg; Seyed A G R Moghadd; Torben Knudsen; Jacob Brodersen; Jesper Frøjk; Jens Frederik Dahlerup; Anders Bo Bojesen; Grith Lykke Sorensen; Steffen Thiel; Nils J Færgeman; Ivan Brandslund; Tue Bjerg Bennike; Allan Stensballe; Erik Berg Schmidt; Andre Franke; David Ellinghaus; Philip Rosenstiel; Jeroen Raes; Mette Boye; Lars Werner; Charlotte Lindgaard Nielsen; Heidi Lausten Munk; Anders Bathum Nexøe; Torkell Ellingsen; Uffe Holmskov; Jens Kjeldsen; Vibeke Andersen

doi:10.1136/bmjopen-2017-018166

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

Robin Christensen, Berit L Heitmann, Karina Winther Andersen, Ole Haagen Nielsen, Signe Bek Sørensen, Mohamad Jawhara, Anette Bygum, Lone Hvid, Jakob Grauslund, Jimmi Wied, Henning Glerup, Ulrich Fredberg, Jan Alexander Villadsen, Søren Geill Kjær, Jan Fallingborg, Seyed A G R Moghadd, Torben Knudsen, Jacob Brodersen, Jesper Frøjk, Jens Frederik DahlerupAnders Bo Bojesen, Grith Lykke Sorensen, Steffen Thiel, Nils J Færgeman, Ivan Brandslund, Tue Bjerg Bennike, Allan Stensballe, Erik Berg Schmidt, Andre Franke, David Ellinghaus, Philip Rosenstiel, Jeroen Raes, Mette Boye, Lars Werner, Charlotte Lindgaard Nielsen, Heidi Lausten Munk, Anders Bathum Nexøe, Torkell Ellingsen, Uffe Holmskov, Jens Kjeldsen, Vibeke Andersen

17 Citations (Scopus)

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.

Original language	English
Journal	BMJ Paediatrics Open
Volume	8
Issue number	2
Pages (from-to)	e018166
ISSN	2399-9772
DOIs	https://doi.org/10.1136/bmjopen-2017-018166
Publication status	Published - 8 Feb 2018

Keywords

Journal Article
Research Support, Non-U.S. Gov't

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10.1136/bmjopen-2017-018166

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Christensen, R., Heitmann, B. L., Andersen, K. W., Nielsen, O. H., Sørensen, S. B., Jawhara, M., Bygum, A., Hvid, L., Grauslund, J., Wied, J., Glerup, H., Fredberg, U., Villadsen, J. A., Kjær, S. G., Fallingborg, J., Moghadd, S. A. G. R., Knudsen, T., Brodersen, J., Frøjk, J., ... Andersen, V. (2018). 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. BMJ Paediatrics Open , 8(2), e018166. https://doi.org/10.1136/bmjopen-2017-018166

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, Robin ; Heitmann, Berit L; Andersen, Karina Winther et al.
In: BMJ Paediatrics Open , Vol. 8, No. 2, 08.02.2018, p. e018166.

Research output: Contribution to journal › Journal article › Research › peer-review

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 2018, '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', BMJ Paediatrics Open , vol. 8, no. 2, pp. e018166. https://doi.org/10.1136/bmjopen-2017-018166

Christensen R , Heitmann BL, Andersen KW, Nielsen OH, Sørensen SB, Jawhara M et al. 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. BMJ Paediatrics Open . 2018 Feb 8;8(2):e018166. doi: 10.1136/bmjopen-2017-018166

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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.",

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T1 - Impact of red and processed meat and fibre intake on treatment outcomes among patients with chronic inflammatory diseases

T2 - protocol for a prospective cohort study of prognostic factors and personalised medicine

AU - Christensen, Robin

AU - Heitmann, Berit L

AU - Andersen, Karina Winther

AU - Nielsen, Ole Haagen

AU - Sørensen, Signe Bek

AU - Jawhara, Mohamad

AU - Bygum, Anette

AU - Hvid, Lone

AU - Grauslund, Jakob

AU - Wied, Jimmi

AU - Glerup, Henning

AU - Fredberg, Ulrich

AU - Villadsen, Jan Alexander

AU - Kjær, Søren Geill

AU - Fallingborg, Jan

AU - Moghadd, Seyed A G R

AU - Knudsen, Torben

AU - Brodersen, Jacob

AU - Frøjk, Jesper

AU - Dahlerup, Jens Frederik

AU - Bojesen, Anders Bo

AU - Sorensen, Grith Lykke

AU - Thiel, Steffen

AU - Færgeman, Nils J

AU - Brandslund, Ivan

AU - Bennike, Tue Bjerg

AU - Stensballe, Allan

AU - Schmidt, Erik Berg

AU - Franke, Andre

AU - Ellinghaus, David

AU - Rosenstiel, Philip

AU - Raes, Jeroen

AU - Boye, Mette

AU - Werner, Lars

AU - Nielsen, Charlotte Lindgaard

AU - Munk, Heidi Lausten

AU - Nexøe, Anders Bathum

AU - Ellingsen, Torkell

AU - Holmskov, Uffe

AU - Kjeldsen, Jens

AU - Andersen, Vibeke

PY - 2018/2/8

Y1 - 2018/2/8

N2 - 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.

AB - 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.

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

U2 - 10.1136/bmjopen-2017-018166

DO - 10.1136/bmjopen-2017-018166

M3 - Journal article

C2 - 29439003

SN - 2399-9772

VL - 8

SP - e018166

JO - BMJ Paediatrics Open

JF - BMJ Paediatrics Open

IS - 2

ER -