FishGastro Study: Fish Consumption and Gastro-Intestinal Health

Study Description

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Brief Summary:

The purpose of the study is to determine whether increasing the dietary intake of n-3 fatty acids by the consumption of oil-rich fish reduces the risk of developing colorectal cancer.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer; Ulcerative Colitis; Polyps	Behavioral: Increased dietary intake of salmon or cod	Not Applicable

Detailed Description:

Epidemiological evidence from several countries supports a protective effect of fish consumption on cancer risk and gastrointestinal cancers in particular. Further evidence to support the idea that fish consumption is protective in relation to cancers of the GI tract is now emerging from the European Investigation into Cancer and Nutrition (EPIC).

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	270 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Fish Consumption and Gastro-Intestinal Health With Special Emphasis on Reduction of Risk of Colon Cancer and Inflammatory Bowel Disease
Study Start Date :	December 2004
Actual Study Completion Date :	April 2008

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Apoptosis in colonic biopsy samples

Secondary Outcome Measures :

1. Cell proliferation
2. lymphocyte infiltration
3. circulating inflammatory markers (cytokines and prostaglandins)
4. tissue inflammatory markers (cytokines and prostaglandins)
5. faecal water cytotoxicity and genotoxicity
6. gene transcription

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ulcerative Colitis Patient Group (Group 1):

• 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:

Ulcerative Colitis Patient Group (Group 1) and Polyps/Resection Group (Group 2):

• 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)

Contacts and Locations

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Locations

Netherlands
University of Wageningen
Wageningen, Netherlands
United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA

Sponsors and Collaborators

Quadram Institute

Wageningen University

University of Jena

University of East Anglia

European Commission

Food Standards Agency, United Kingdom

Investigators

Principal Investigator:	Elizabeth K Lund, PhD	Quadram Institute

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00145015 History of Changes
Other Study ID Numbers:	IFR02/2004
First Posted:	September 5, 2005
Last Update Posted:	July 30, 2008
Last Verified:	July 2008

Keywords provided by Quadram Institute:

Intervention; Adults; Colorectal cancer; Nutrition; Fish	n-3 fatty acids; Apoptosis; Ulcerative colitis; Polyps; Gastro-intestinal tract

Additional relevant MeSH terms:

Colorectal Neoplasms; Colitis; Ulcer; Colitis, Ulcerative; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms	Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis; Pathologic Processes; Inflammatory Bowel Diseases