FishGastro Study: Fish Consumption and Gastro-Intestinal Health

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145015
• Other study ID #: IFR02/2004
• Status: Completed
• Phase: N/A
• First received: September 1, 2005
• Last updated: July 29, 2008
• Start date: December 2004
• Est. completion date: April 2008

Study information

• Verified date: July 2008
• Source: Institute of Food Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Colorectal Cancer
• Colorectal Neoplasms
• Polyps
• Ulcerative Colitis

Intervention

Behavioral:
• Increased dietary intake of salmon or cod

Locations

Country	Name	City	State
Netherlands	University of Wageningen	Wageningen
United Kingdom	Institute of Food Research	Norwich	Norfolk

Sponsors (6)

Lead Sponsor	Collaborator
Institute of Food Research	European Commission, Food Standards Agency, United Kingdom, University of East Anglia, University of Jena, Wageningen University

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apoptosis in colonic biopsy samples
Secondary	Cell proliferation
Secondary	lymphocyte infiltration
Secondary	circulating inflammatory markers (cytokines and prostaglandins)
Secondary	tissue inflammatory markers (cytokines and prostaglandins)
Secondary	faecal water cytotoxicity and genotoxicity
Secondary	gene transcription

External Links

•   Click here for more information about the Fishgastro Study