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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Polyps; Ulcerative Colitis
• 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

Study Locations

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

Participation Criteria

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

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

• 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

General Publications

• Pot GK, Geelen A, Majsak-Newman G, Harvey LJ, Nagengast FM, Witteman BJ, van de Meeberg PC, Hart AR, Schaafsma G, Lund EK, Rijkers GT, Kampman E. Increased consumption of fatty and lean fish reduces serum C-reactive protein concentrations but not inflammation markers in feces and in colonic biopsies. J Nutr. 2010 Feb;140(2):371-6. doi: 10.3945/jn.109.113472. Epub 2009 Dec 23.
• Pot GK, Majsak-Newman G, Geelen A, Harvey LJ, Nagengast FM, Witteman BJ, van de Meeberg PC, Timmer R, Tan A, Wahab PJ, Hart AR, Williams MP, Przybylska-Phillips K, Dainty JR, Schaafsma G, Kampman E, Lund EK; FISHGASTRO Study Group. Fish consumption and markers of colorectal cancer risk: a multicenter randomized controlled trial. Am J Clin Nutr. 2009 Aug;90(2):354-61. doi: 10.3945/ajcn.2009.27630. Epub 2009 Jun 24.

Study record dates

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: September 1, 2005
• First Posted (Estimate): September 5, 2005

Study Record Updates

• Last Update Posted (Estimate): July 30, 2008
• Last Update Submitted That Met QC Criteria: July 29, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Colorectal cancer; Adults; Nutrition; n-3 fatty acids; Intervention; Ulcerative colitis; Apoptosis; Polyps; Fish; Gastro-intestinal tract
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Inflammatory Bowel Diseases; Ulcer; Colorectal Neoplasms; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: IFR02/2004