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FishGastro Study: Fish Consumption and Gastro-Intestinal Health
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Purpose
| Condition | Intervention |
|---|---|
| Colorectal Cancer Ulcerative Colitis Polyps | Behavioral: Increased dietary intake of salmon or cod |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (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 |
- Apoptosis in colonic biopsy samples
- 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 |
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00145015
| Netherlands | |
| University of Wageningen | |
| Wageningen, Netherlands | |
| United Kingdom | |
| Institute of Food Research | |
| Norwich, Norfolk, United Kingdom, NR4 7UA | |
| Principal Investigator: | Elizabeth K Lund, PhD | Quadram Institute |
More Information
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 |
Keywords provided by Quadram Institute:
|
Intervention Adults Colorectal cancer Nutrition Fish |
n-3 fatty acids Apoptosis Ulcerative colitis Polyps Gastro-intestinal tract |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Colitis Ulcer Colitis, Ulcerative Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Gastroenteritis Pathologic Processes Inflammatory Bowel Diseases |
ClinicalTrials.gov processed this record on September 19, 2017