FishGastro Study: Fish Consumption and Gastro-Intestinal Health
NCT ID: NCT00145015
Last Updated: 2008-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
270 participants
INTERVENTIONAL
2004-12-31
2008-04-30
Brief Summary
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Detailed Description
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The FISHGASTRO project is headed by the Institute of Food Research and includes groups from the University of East Anglia, the University of Wageningen, Netherlands and the University of Jena, Germany. The project focuses on assessing the impact of fish consumption on a range of markers of gastrointestinal health associated with ulcerative colitis or colon cancer and on looking at bio-accessibility of a range of nutrients from fish. We aim to recruit a total of 270 patients with gastrointestinal problems in the UK and Netherlands and take biopsy and blood samples before and after asking them to eat two extra portions of fish per week. One group will receive oil rich fish such as salmon while another will be asked to eat white fish. Changes in cell proliferation, apoptosis, inflammatory markers, gene expression and plasma levels of n-3 fatty acids will be compared to a control group only given standard nutritional advice.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Interventions
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Increased dietary intake of salmon or cod
Eligibility Criteria
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Inclusion Criteria
* Aged 18 - 80
* Male or female
* Diagnosed with ulcerative colitis
* Attending gastroenterology clinic for routine colonoscopy check-up
* Willing to increase dietary intake of fish for six months
* Willing to undergo a flexible sigmoidoscopy examination
Polyps/Resection Group (Group 2):
* Aged 18 - 80
* Male or female
* A history of polyps in the colon
* Attending gastroenterology clinic for routine colonoscopy check-up
* Willing to increase dietary intake of fish for six months
* Willing to undergo a flexible sigmoidoscopy examination
Control Group (Group 3):
* Aged 18 - 80
* Male or female
* Booked for a colonoscopy examination for the investigation of iron deficiency anaemia of unknown cause (no evidence of macroscopic disease found during examination)
* Willing to increase dietary intake of fish for six months
* Willing to undergo a flexible sigmoidoscopy examination
Exclusion Criteria
* Allergic to fish
* Receiving anticoagulant therapy
* Diabetics
* Pregnant or breast-feeding
* Organ transplant recipients receiving immunosuppression therapy
* Prosthetic heart valve
* Allergic to pethidine
* Previous diagnosis of bacterial endocarditis
Control Group (Group 3):
Same as Groups 1 and 2 plus:
* Received a diagnosis of colorectal cancer following initial investigative colonoscopy (volunteer will be withdrawn from the study when diagnosed as requiring treatment)
* Received a diagnosis of coeliac disease following initial investigative colonoscopy (volunteer will be withdrawn from the study when diagnosed as requiring a modified diet)
18 Years
80 Years
ALL
No
Sponsors
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Wageningen University
OTHER
University of Jena
OTHER
University of East Anglia
OTHER
European Commission
OTHER
Food Standards Agency, United Kingdom
OTHER_GOV
Quadram Institute Bioscience
OTHER
Principal Investigators
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Elizabeth K Lund, PhD
Role: PRINCIPAL_INVESTIGATOR
Quadram Institute Bioscience
Locations
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University of Wageningen
Wageningen, , Netherlands
Institute of Food Research
Norwich, Norfolk, United Kingdom
Countries
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References
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Pot GK, Geelen A, Majsak-Newman G, Harvey LJ, Nagengast FM, Witteman BJ, van de Meeberg PC, Hart AR, Schaafsma G, Lund EK, Rijkers GT, Kampman E. Increased consumption of fatty and lean fish reduces serum C-reactive protein concentrations but not inflammation markers in feces and in colonic biopsies. J Nutr. 2010 Feb;140(2):371-6. doi: 10.3945/jn.109.113472. Epub 2009 Dec 23.
Pot GK, Majsak-Newman G, Geelen A, Harvey LJ, Nagengast FM, Witteman BJ, van de Meeberg PC, Timmer R, Tan A, Wahab PJ, Hart AR, Williams MP, Przybylska-Phillips K, Dainty JR, Schaafsma G, Kampman E, Lund EK; FISHGASTRO Study Group. Fish consumption and markers of colorectal cancer risk: a multicenter randomized controlled trial. Am J Clin Nutr. 2009 Aug;90(2):354-61. doi: 10.3945/ajcn.2009.27630. Epub 2009 Jun 24.
Other Identifiers
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IFR02/2004
Identifier Type: -
Identifier Source: org_study_id