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 & 21 others 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

Research output: Contribution to journalJournal articleResearchpeer-review

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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.

Original languageEnglish
Article numbere018166
JournalB M J Open
Volume8
Issue number2
Number of pages17
ISSN2044-6055
DOIs
Publication statusPublished - Feb 2018

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Precision Medicine
Cohort Studies
Prospective Studies
Tumor Necrosis Factor-alpha
Hidradenitis Suppurativa
Quality of Life
Ethics Committees
Psoriatic Arthritis
Red Meat
Uveitis
Ulcerative Colitis
Inflammatory Bowel Diseases
Psoriasis
Skin Diseases
Crohn Disease
Registries
Comorbidity

Keywords

  • Journal Article
  • Research Support, Non-U.S. Gov't
  • patient related outcome measures
  • biomarker and lifestyle
  • lifestyle and chronic inflammatory disease
  • western style diet
  • treatment outcome
  • personalized medicine

Cite this

Christensen, Robin ; Heitmann, Berit L ; Andersen, Karina Winther ; Nielsen, Ole Haagen ; Sørensen, Signe Bek ; Jawhara, Mohamad ; Bygum, Anette ; Hvid, Lone ; Grauslund, Jakob ; Wied, Jimmi ; Glerup, Henning ; Fredberg, Ulrich ; Villadsen, Jan Alexander ; Kjær, Søren Geill ; Fallingborg, Jan ; Moghadd, Seyed A G R ; Knudsen, Torben ; Brodersen, Jacob ; Frøjk, Jesper ; Dahlerup, Jens Frederik ; Bojesen, Anders Bo ; Sorensen, Grith Lykke ; Thiel, Steffen ; Færgeman, Nils J ; Brandslund, Ivan ; Bennike, Tue Bjerg ; Stensballe, Allan ; Schmidt, Erik Berg ; Franke, Andre ; Ellinghaus, David ; Rosenstiel, Philip ; Raes, Jeroen ; Boye, Mette ; Werner, Lars ; Nielsen, Charlotte Lindgaard ; Munk, Heidi Lausten ; Nexøe, Anders Bathum ; Ellingsen, Torkell ; Holmskov, Uffe ; Kjeldsen, Jens ; Andersen, Vibeke. / 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. In: B M J Open. 2018 ; Vol. 8, No. 2.
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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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author = "Robin Christensen and Heitmann, {Berit L} and Andersen, {Karina Winther} and Nielsen, {Ole Haagen} and S{\o}rensen, {Signe Bek} and Mohamad Jawhara and Anette Bygum and Lone Hvid and Jakob Grauslund and Jimmi Wied and Henning Glerup and Ulrich Fredberg and Villadsen, {Jan Alexander} and Kj{\ae}r, {S{\o}ren Geill} and Jan Fallingborg and Moghadd, {Seyed A G R} and Torben Knudsen and Jacob Brodersen and Jesper Fr{\o}jk and Dahlerup, {Jens Frederik} and Bojesen, {Anders Bo} and Sorensen, {Grith Lykke} and Steffen Thiel and F{\ae}rgeman, {Nils J} and Ivan Brandslund and Bennike, {Tue Bjerg} and Allan Stensballe and Schmidt, {Erik Berg} and Andre Franke and David Ellinghaus and Philip Rosenstiel and Jeroen Raes and Mette Boye and Lars Werner and Nielsen, {Charlotte Lindgaard} and Munk, {Heidi Lausten} and Nex{\o}e, {Anders Bathum} and Torkell Ellingsen and Uffe Holmskov and Jens Kjeldsen and Vibeke Andersen",
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year = "2018",
month = "2",
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language = "English",
volume = "8",
journal = "B M J Open",
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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. / Christensen, Robin; Heitmann, Berit L; Andersen, Karina Winther; Nielsen, Ole Haagen; Sørensen, Signe Bek; Jawhara, Mohamad; Bygum, Anette; Hvid, Lone; Grauslund, Jakob; Wied, Jimmi; Glerup, Henning; Fredberg, Ulrich; Villadsen, Jan Alexander; Kjær, Søren Geill; Fallingborg, Jan; Moghadd, Seyed A G R; Knudsen, Torben; Brodersen, Jacob; Frøjk, Jesper; Dahlerup, Jens Frederik; Bojesen, Anders Bo; Sorensen, Grith Lykke; Thiel, Steffen; Færgeman, Nils J; Brandslund, Ivan; Bennike, Tue Bjerg; Stensballe, Allan; Schmidt, Erik Berg; Franke, Andre; Ellinghaus, David; Rosenstiel, Philip; Raes, Jeroen; Boye, Mette; Werner, Lars; Nielsen, Charlotte Lindgaard; Munk, Heidi Lausten; Nexøe, Anders Bathum; Ellingsen, Torkell; Holmskov, Uffe; Kjeldsen, Jens; Andersen, Vibeke.

In: B M J Open, Vol. 8, No. 2, e018166, 02.2018.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

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

N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PY - 2018/2

Y1 - 2018/2

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

KW - patient related outcome measures

KW - biomarker and lifestyle

KW - lifestyle and chronic inflammatory disease

KW - western style diet

KW - treatment outcome

KW - personalized medicine

U2 - 10.1136/bmjopen-2017-018166

DO - 10.1136/bmjopen-2017-018166

M3 - Journal article

VL - 8

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 2

M1 - e018166

ER -