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| Sponsors and Collaborators: |
Institute of Food Research 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 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer Ulcerative Colitis Polyps |
Behavioral: Increased dietary intake of salmon or cod |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Fish Consumption and Gastro-Intestinal Health With Special Emphasis on Reduction of Risk of Colon Cancer and Inflammatory Bowel Disease |
| 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Ulcerative Colitis Patient Group (Group 1):
Polyps/Resection Group (Group 2):
Control Group (Group 3):
Exclusion Criteria:
Ulcerative Colitis Patient Group (Group 1) and Polyps/Resection Group (Group 2):
Control Group (Group 3):
Same as Groups 1 and 2 plus:
Contacts and Locations| Netherlands | |
| University of Wageningen | |
| Wageningen, Netherlands | |
| United Kingdom, Norfolk | |
| Institute of Food Research | |
| Norwich, Norfolk, United Kingdom, NR4 7UA | |
| Principal Investigator: | Elizabeth K Lund, PhD | Institute of Food Research |
More Information
| Study ID Numbers: | IFR02/2004 |
| Study First Received: | September 1, 2005 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00145015 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Intervention Adults Colorectal cancer Nutrition Fish |
n-3 fatty acids Apoptosis Ulcerative colitis Polyps Gastro-intestinal tract |
|
Digestive System Neoplasms Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases Colitis, Ulcerative Polyps Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Gastroenteritis Colitis Colorectal Neoplasms |
|
Neoplasms Pathologic Processes Neoplasms by Site |
