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FishGastro Study: Fish Consumption and Gastro-Intestinal Health

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00145015
Enrollment
270
Registered
2005-09-05
Start date
2004-12-31
Completion date
2008-04-30
Last updated
2008-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Polyps, Ulcerative Colitis

Keywords

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

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.

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.

Interventions

BEHAVIORALIncreased dietary intake of salmon or cod

Sponsors

Wageningen University
CollaboratorOTHER
University of Jena
CollaboratorOTHER
University of East Anglia
CollaboratorOTHER
European Commission
CollaboratorOTHER
Food Standards Agency, United Kingdom
CollaboratorOTHER_GOV
Quadram Institute Bioscience
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Apoptosis in colonic biopsy samples

Secondary

MeasureTime frame
lymphocyte infiltration
circulating inflammatory markers (cytokines and prostaglandins)
Cell proliferation
faecal water cytotoxicity and genotoxicity
gene transcription
tissue inflammatory markers (cytokines and prostaglandins)

Countries

Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026