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	Intervention
Colorectal Cancer Ulcerative Colitis Polyps	Behavior: Increased dietary intake of salmon or cod

Further Study Details: 

Primary Outcomes: Apoptosis in colonic biopsy samples.
Secondary Outcomes: Cell proliferation,; lymphocyte infiltration,; circulating inflammatory markers (cytokines and prostaglandins),; tissue inflammatory markers(cytokines and prostaglandins),; faecal water cytotoxicity and genotoxicity,; gene transcription
Expected Total Enrollment:  270

Epidemiological evidence from several countries supports a protective effect of fish comsumption 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.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00145015

Elizabeth K Lund, PhD      +44 (0)1603 255347    liz.lund@bbsrc.ac.uk
Linda J Harvey, PhD      +44 (0)1603 255191    linda.harvey@bbsrc.ac.uk

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

Study chairs or principal investigators

Elizabeth K Lund, PhD,  Principal Investigator,  Institute of Food Research   

Study ID Numbers:  IFR02/2004
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-09-06