Increased dietary intake of salmon or cod in Colorectal Cancer and Polyps and Ulcerative Colitis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: Increased dietary intake of salmon or cod

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.

Study Type

Interventional

Enrollment (Anticipated)

270

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- - Wageningen, Netherlands
    - University of Wageningen
United Kingdom
- Norfolk
  - Norwich, Norfolk, United Kingdom, NR4 7UA
    - Institute of Food Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Apoptosis in colonic biopsy samples

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quadram Institute Bioscience

Collaborators

University of Jena

University of East Anglia

Wageningen University

European Commission

Food Standards Agency, United Kingdom

Investigators

Principal Investigator: Elizabeth K Lund, PhD, Quadram Institute Bioscience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria