FishGastro Study: Fish Consumption and Gastro-Intestinal Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Colorectal Cancer, Ulcerative Colitis, Polyps

Intervention / Treatment
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* Behavioral: Increased dietary intake of salmon or cod


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Increased dietary intake of salmon or cod|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apoptosis in colonic biopsy samples |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell proliferation |  |  | 
| lymphocyte infiltration |  |  | 
| circulating inflammatory markers (cytokines and prostaglandins) |  |  | 
| tissue inflammatory markers (cytokines and prostaglandins) |  |  | 
| faecal water cytotoxicity and genotoxicity |  |  | 
| gene transcription |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervention, Adults, Colorectal cancer, Nutrition, Fish, n-3 fatty acids, Apoptosis, Ulcerative colitis, Polyps, Gastro-intestinal tract