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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
History of Changes

September 1, 2005
July 29, 2008
December 2004
Not Provided
Apoptosis in colonic biopsy samples
Apoptosis in colonic biopsy samples.
Complete list of historical versions of study NCT00145015 on ClinicalTrials.gov Archive Site
  • Cell proliferation
  • lymphocyte infiltration
  • circulating inflammatory markers (cytokines and prostaglandins)
  • tissue inflammatory markers (cytokines and prostaglandins)
  • faecal water cytotoxicity and genotoxicity
  • gene transcription
  • Cell proliferation,
  • lymphocyte infiltration,
  • circulating inflammatory markers (cytokines and prostaglandins),
  • tissue inflammatory markers(cytokines and prostaglandins),
  • faecal water cytotoxicity and genotoxicity,
  • gene transcription
Not Provided
Not Provided
 
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

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Colorectal Cancer
  • Ulcerative Colitis
  • Polyps
Behavioral: Increased dietary intake of salmon or cod
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
April 2008
Not Provided

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom
 
NCT00145015
IFR02/2004
Not Provided
Not Provided
Institute of Food Research
  • Wageningen University
  • University of Jena
  • University of East Anglia
  • European Commission
  • Food Standards Agency, United Kingdom
Principal Investigator: Elizabeth K Lund, PhD Institute of Food Research
Institute of Food Research
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP