NCT Number: NCT00145015
FishGastro Study: Fish Consumption and Gastro-Intestinal Health
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.
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Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
University of Wageningen, Wageningen, Netherlands
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Primary outcomes
-
Apoptosis in colonic biopsy samples
Secondary outcomes
-
Cell proliferation
-
lymphocyte infiltration
-
circulating inflammatory markers (cytokines and prostaglandins)
-
tissue inflammatory markers (cytokines and prostaglandins)
-
faecal water cytotoxicity and genotoxicity
-
gene transcription
Sponsors and collaborators
Lead sponsor
Quadram Institute Bioscience
Other
Collaborators
- European Commission
- Food Standards Agency, United Kingdom
- University of East Anglia
- University of Jena
- Wageningen University
Registry information
Official study title
Fish Consumption and Gastro-Intestinal Health With Special Emphasis on Reduction of Risk of Colon Cancer and Inflammatory Bowel Disease
Important dates
- Study start
- 2004
- Study completion
- 2008
- First posted
- Sep 5, 2005
- Registry last updated
- Jul 30, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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