Chronic Inflammatory Disease, Lifestyle and Risk of Disease

NCT03456206 | Unknown

• 1 other identifier: PROCID-DCH
• Study Type: observational
• Target: 57,053
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic inflammatory diseases (CID) - including inflammatory bowel diseases (Crohn's disease and ulcerative colitis), rheumatic conditions (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis) and multiple sclerosis are diseases of the immune system that have some shared genetic and environmental predisposing factors, but still little is known on the effects of lifestyle as a prognostic factor on disease risk. This observational study will contribute to preexisting research on lifestyle factors by identifying diet factors associated with risk of developing CID, using prospective register data. The study will use data from all of the 57,053 participants in the Danish cohort "Diet, Health and Cancer (DHC)" together with registry data. Blood samples, anthropometric measures and questionnaire data on diet and lifestyle were collected at the DHC study entry. The National Patient Registry (NPR) will be used to obtain to identify patients with CID during follow-up. Follow-up information on death and immigration will be collected in March 2018 from the Danish Civil Registration Register. The outcome CID is defined as at least one of the following CIDs: Crohn's disease, ulcerative colitis, psoriasis/psoriatic arthritis, rheumatoid arthritis/ankylosing arthritis, or multiple sclerosis, during the follow-up period from 1993 to March 2018. The primary hypothesis is that "the risk of CID will be significantly higher among those with a low fibre/high red and processed meat intake compared to those with a high fibre/low red and processed meat intake." Based on previous research on a shared etiology in CIDs a second hypothesis is that "the postulated causality between low fibre/high red and processed meat intake and risk of developing CID is applicable for each of the CID-diagnoses." The core study is an open register-based cohort study. The study does not need approval from the local Ethics committee or Institutional Review Board by Danish law. The study was approved by the Danish Data Protection Agency (2012-58-0018) Study findings will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.

Conditions

Autoimmune Diseases; Inflammatory Bowel Diseases; Crohn Disease (CD); Ulcerative Colitis (UC); Arthritis, Rheumatoid (RA); Spondylarthropathies; Arthritis, Psoriatic (PsA); Psoriasis (PsO); Multiple Sclerosis (MS)

Keywords

Life Style; Diet; Food; CID; Disease risk

Outcome Measures

Primary Outcomes (1)

• CID diagnosis

  * Crohn's disease (yes/no) * Ulcerative colitis (yes/no) * Rheumatoid arthritis (yes/no) * Axial spondyloarthritis (yes/no) * Psoriatic arthritis (yes/no) * Psoriasis (yes/no) * Multiple sclerosis (yes/no)

  24-28 years

Study Arms (1)

"Diet, Cancer and Health" cohort

Participants from the "Diet, Cancer and Health" (DCH) cohort with no CID diagnosis at entry to the DCH study. The number of persons developing a CID (defined as at least one of the mentioned CIDs) during follow up (1993/1997 - 2018) and the number of persons not developing a CID will be investigated. Based on the participants reporting of dietary habits in the Food Frequency Questionnaire (FFQ) from the DCH study, the exposure "intake of red and processed meat and fibres" will be investigated in both CID cases and non-cases. Other exposure variables are "Lifestyle factors independently or combined" and are also obtained from the data in the DCH cohort.

Other: Intake of red and processed meat and fibres; Other: Lifestyle factors independently or combined

Interventions

Intake of red and processed meat and fibres OTHER

The intention is to analyse exposure groups in tertiles: 1) Upper tertile (33.3% of the total sample) based on the ratio: meat/fibre intake is associated with higher risk of CID. 2) Low intake of fibre (defined as below the lower tertile \[33.3% of the total sample\]) and high intake of red and processed meat (defined as those above the upper tertile \[33.3% of the total sample\]) are independently associated with higher risk of CID, and their synergy (interaction between the factors meat and fibres) gives the highest risk outcome.

"Diet, Cancer and Health" cohort

Lifestyle factors independently or combined OTHER

Lifestyles factors are defined as: red and processed meat, vegetables, dietary fibre, cereals, gluten, legumes, red wine, dairy products, physical activity, smoking, total protein/fat, protein/fat from red and processed meat, glycemic index.

"Diet, Cancer and Health" cohort

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All 57,053 participants from the DHC cohort

You may qualify if:

• Participant in the DHC cohort

You may not qualify if:

• Participant with a CID diagnosis at entry

Sponsors & Collaborators

• University of Southern Denmark: lead
• Hospital of Southern Jutland: collaborator
• Odense Patient Data Explorative Network: collaborator
• University of Aarhus: collaborator
• Danish Cancer Society: collaborator

Study Sites (1)

University of Southern Denmark

Odense, 5230, Denmark

Location

Related Publications (1)

• Rasmussen NF, Rubin KH, Stougaard M, Tjonneland A, Stenager E, Lund Hetland M, Glintborg B, Bygum A, Andersen V. Impact of red meat, processed meat and fibre intake on risk of late-onset chronic inflammatory diseases: prospective cohort study on lifestyle factors using the Danish 'Diet, Cancer and Health' cohort (PROCID-DCH): protocol. BMJ Open. 2019 Mar 30;9(3):e024555. doi: 10.1136/bmjopen-2018-024555.

  PMID: 30928934 DERIVED

Related Links

• Intake of dietary fibre, red and processed meat and risk of late-onset Chronic Inflammatory Diseases: A prospective Danish study on the "diet, cancer and health" cohort

MeSH Terms

Conditions

Autoimmune Diseases; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Arthritis, Rheumatoid; Spondylarthropathies; Arthritis, Psoriatic; Psoriasis; Multiple Sclerosis

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Vibeke Andersen, Prof

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 7, 2018
• Study Start: November 10, 2018
• Primary Completion: September 1, 2020
• Study Completion: May 1, 2023
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)