Study Design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: Fish Consumption and Gastro-Intestinal Health With Special Emphasis on Reduction of Risk of Colon Cancer and Inflammatory Bowel Disease

Further study details as provided by Institute of Food Research:

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

Study start: December 2004; Expected completion: January 2008

Last follow-up: January 2008; Data entry closure: January 2008

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 chairs or principal investigators

Elizabeth K Lund, PhD, Principal Investigator, Institute of Food Research +44 (0)1603 255347

Ann Fonfa's Correspondence with Dr. Lund

May, 2006

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