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FishGastro Study: Fish Consumption and Gastro-Intestinal Health

Primary Purpose

Colorectal Cancer, Ulcerative Colitis, Polyps

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Increased dietary intake of salmon or cod
Sponsored by
Quadram Institute Bioscience
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Intervention, Adults, Colorectal cancer, Nutrition, Fish, n-3 fatty acids, Apoptosis, Ulcerative colitis, Polyps, Gastro-intestinal tract

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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1 and 2 plus: Received a diagnosis of colorectal cancer following initial investigative colonoscopy (volunteer will be withdrawn from the study when diagnosed as requiring treatment) Received a diagnosis of coeliac disease following initial investigative colonoscopy (volunteer will be withdrawn from the study when diagnosed as requiring a modified diet)

Sites / Locations

  • University of Wageningen
  • Institute of Food Research

Outcomes

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

Full Information

First Posted
September 1, 2005
Last Updated
July 29, 2008
Sponsor
Quadram Institute Bioscience
Collaborators
Wageningen University, University of Jena, University of East Anglia, European Commission, Food Standards Agency, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT00145015
Brief Title
FishGastro Study: Fish Consumption and Gastro-Intestinal Health
Official Title
Fish Consumption and Gastro-Intestinal Health With Special Emphasis on Reduction of Risk of Colon Cancer and Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Quadram Institute Bioscience
Collaborators
Wageningen University, University of Jena, University of East Anglia, European Commission, Food Standards Agency, United Kingdom

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Ulcerative Colitis, Polyps
Keywords
Intervention, Adults, Colorectal cancer, Nutrition, Fish, n-3 fatty acids, Apoptosis, Ulcerative colitis, Polyps, Gastro-intestinal tract

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Increased dietary intake of salmon or cod
Primary Outcome Measure Information:
Title
Apoptosis in colonic biopsy samples
Secondary Outcome Measure Information:
Title
Cell proliferation
Title
lymphocyte infiltration
Title
circulating inflammatory markers (cytokines and prostaglandins)
Title
tissue inflammatory markers (cytokines and prostaglandins)
Title
faecal water cytotoxicity and genotoxicity
Title
gene transcription

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth K Lund, PhD
Organizational Affiliation
Quadram Institute Bioscience
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wageningen
City
Wageningen
Country
Netherlands
Facility Name
Institute of Food Research
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20032491
Citation
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.
Results Reference
derived
PubMed Identifier
19553301
Citation
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.
Results Reference
derived

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FishGastro Study: Fish Consumption and Gastro-Intestinal Health

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