Block 1. Two intervention studies, including subjects with no apparent disease, patients with polyps and patients with ulcerative colitis (months 0-50)
Two intervention studies are planned, one in the UK and one in The Netherlands. The finalised design of the intervention studies will be agreed between partners at the start of the project including numbers of participants to give sufficient statistical power, recruitment approach, methods of dietary assessment and techniques to ensure compliance. Initial dietary assessment techniques will be developed in co-ordination with project 1.2. These aspects of design are absolutely critical to final interpretation of results. Participants will then obtain ethical permission from their respective authorities and intervention will only then be started. Currently it is aimed to recruit 10-15 people per intervention in each country, to obtain sufficient power for assessment of apoptosis, and all volunteer patients will receive dietary advice. In each of the three groups (normal subjects, polyps patients, ulcerative colitis patients) a control diet, will be tested versus diets containing lean seafood, and fatty seafood diet. It is anticipated that these people will be recruited over a three year period in order to get sufficient numbers. Following intervention patients will be encouraged to maintain their diet by continued contact with researchers and assessment of dietary intake at 6 monthly intervals by food diary so that follow up in relation to ‘harder’ more clinical end-points can be obtained. Partners involved are 5.IFR, 8.WU-HNE and 14.FSU.
Block 2. Analysis of markers for cancer risk and inflammation, measurement of fish protein bioavailability and assessment of gene expression using post genomic technologies (months 6-60)
Specific expertise available at different institutions will be used in cooperation to assess in the different human studies by innovative techniques new markers of gastrointestinal health. These markers include markers of cancer risk/protection such as apoptosis, cell proliferation, inflammation, fish protein bioavailability and gene expression. The gene expression studies will provide a particularly novel aspect to the work as patients under investigation from the start will be encouraged to maintain their diet and real disease end-points such as polyps recurrence and overt inflammatory damage will be linked to changes in the patterns off gene expression seen during the intervention study. Partners involved are 5.IFR, 8.WU-HNE, 14.FSU and 13.TNO.
The work undertaken within FISHGASTRO builds on work already being undertaken within the associated groups. The use of IFR human micro-arrays is only financially possible because of the work previously undertaken at IFR to establish methodology. The knowledge base associated with fish oil consumption and gene expression builds on work in cell culture models. This work was funded by the UK Biotechnology and Biological Sciences Research Council (BBSRC) core strategic grant (CSG) to IFR. The work on inflammatory bowel disease (IBD) will be associated with current work undertaken by Dr Andrew Hart (UEA - subcontractor to IFR) looking at IBD and diet in the EPIC cohort. The work in Wageningen links with ongoing cohort studies for which further funding is currently being sought from the Netherlands Digestive Diseases Foundation and at FSU the work is being conducted in parallel with studies on ‘Modulation of Gene expression in target cells of colon cancer’ and ‘Development of biomarkers to assess chemopreventive effects in humans’, both funded by the Deutsche Forschungsgemeinschaft, (DFG). At IFR matching funding for the project is being obtained from the UK Food Standards Agency (FSA) and the more fundamental aspects will receive continuing support from our BBSRC -CSG. IFR is also seeking a small grant for student work from The Worshipful Company of Fishmongers (an ancient guild).