FishGastro Study: Fish Consumption and Gastro-Intestinal Health

This study has been completed.
Sponsor:
Collaborators:
Wageningen University
University of Jena
University of East Anglia
European Commission
Food Standards Agency, United Kingdom
Information provided by:
Institute of Food Research
ClinicalTrials.gov Identifier:
NCT00145015
First received: September 1, 2005
Last updated: July 29, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention
Colorectal Cancer
Ulcerative Colitis
Polyps
Behavioral: Increased dietary intake of salmon or cod

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Fish Consumption and Gastro-Intestinal Health With Special Emphasis on Reduction of Risk of Colon Cancer and Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Institute of Food Research:

Primary Outcome Measures:
  • Apoptosis in colonic biopsy samples

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

Estimated Enrollment: 270
Study Start Date: December 2004
Study Completion Date: April 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145015

Locations
Netherlands
University of Wageningen
Wageningen, Netherlands
United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Sponsors and Collaborators
Institute of Food Research
Wageningen University
University of Jena
University of East Anglia
European Commission
Food Standards Agency, United Kingdom
Investigators
Principal Investigator: Elizabeth K Lund, PhD Institute of Food Research
  More Information

Additional Information:
No publications provided by Institute of Food Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00145015     History of Changes
Other Study ID Numbers: IFR02/2004
Study First Received: September 1, 2005
Last Updated: July 29, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Institute of Food Research:
Intervention
Adults
Colorectal cancer
Nutrition
Fish
n-3 fatty acids
Apoptosis
Ulcerative colitis
Polyps
Gastro-intestinal tract

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Colorectal Neoplasms
Inflammatory Bowel Diseases
Polyps
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Pathological Conditions, Anatomical
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014