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Fish Consumption and Gastro-Intestinal Health With Special Emphasis on Reduction of Risk of Colon Cancer and Inflammatory Bowel Disease


N/A
18 Years
80 Years
Not Enrolling
Both
Colorectal Cancer, Ulcerative Colitis, Polyps

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Trial Information

Fish Consumption and Gastro-Intestinal Health With Special Emphasis on Reduction of Risk of Colon Cancer and Inflammatory Bowel Disease


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Apoptosis in colonic biopsy samples

Principal Investigator

Elizabeth K Lund, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Food Research

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

IFR02/2004

NCT ID:

NCT00145015

Start Date:

December 2004

Completion Date:

April 2008

Related Keywords:

  • Colorectal Cancer
  • Ulcerative Colitis
  • Polyps
  • Intervention
  • Adults
  • Colorectal cancer
  • Nutrition
  • Fish
  • n-3 fatty acids
  • Apoptosis
  • Ulcerative colitis
  • Polyps
  • Gastro-intestinal tract
  • Colitis
  • Colitis, Ulcerative
  • Colorectal Neoplasms
  • Inflammatory Bowel Diseases
  • Polyps
  • Ulcer

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