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Chronic Inflammatory Disease, Lifestyle and Risk of Disease (PROCID-DHC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03456206
Recruitment Status : Active, not recruiting
First Posted : March 7, 2018
Last Update Posted : April 8, 2019
Sponsor:
Collaborators:
Hospital of Southern Jutland
Odense Patient Data Explorative Network
University of Aarhus
Danish Cancer Society
Information provided by (Responsible Party):
Vibeke Andersen, University of Southern Denmark

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.


Condition or disease Intervention/treatment
Autoimmune Diseases Inflammatory Bowel Diseases Crohn Disease (CD) Ulcerative Colitis (UC) Arthritis, Rheumatoid (RA) Spondylarthropathies Arthritis, Psoriatic (PsA) Psoriasis (PsO) Multiple Sclerosis (MS) Other: Intake of red and processed meat and fibres Other: Lifestyle factors independently or combined

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 57053 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Years
Official Title: Impact of Red and Processed Meat and Fibre Intake on Risk of Chronic Inflammatory Diseases: a Prospective Cohort Study on Prognostic Factors Using the Danish "Diet, Health and Cancer" Cohort
Actual Study Start Date : November 10, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Group/Cohort Intervention/treatment
"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
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.

Other: Lifestyle factors independently or combined
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.




Primary Outcome Measures :
  1. CID diagnosis [ Time Frame: 24-28 years ]
    • 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)



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Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All 57,053 participants from the DHC cohort
Criteria

Inclusion Criteria:

  • Participant in the DHC cohort

Exclusion Criteria:

  • Participant with a CID diagnosis at entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456206


Locations
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Denmark
University of Southern Denmark
Odense, Denmark, 5230
Sponsors and Collaborators
University of Southern Denmark
Hospital of Southern Jutland
Odense Patient Data Explorative Network
University of Aarhus
Danish Cancer Society
Investigators
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Principal Investigator: Vibeke Andersen, Prof University of Southern Denmark

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vibeke Andersen, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03456206     History of Changes
Other Study ID Numbers: PROCID-DHC
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vibeke Andersen, University of Southern Denmark:
Life Style
Diet
Food
CID
Disease risk

Additional relevant MeSH terms:
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Arthritis
Multiple Sclerosis
Psoriasis
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Autoimmune Diseases
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylarthropathies
Joint Diseases
Musculoskeletal Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Rheumatic Diseases
Connective Tissue Diseases
Spondylarthritis
Spondylitis
Spinal Diseases