Clinical trial NCT00145015: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Ulcerative Colitis
Polyps
Keywords: Intervention
Adults
Colorectal cancer
Nutrition
Fish
n-3 fatty acids
Apoptosis
Ulcerative colitis
Polyps
Gastro-intestinal tract
Lead sponsor: Quadram Institute Bioscience
Sponsor class: OTHER
Collaborators: name: Wageningen University
name: University of Jena
name: University of East Anglia
name: European Commission
name: Food Standards Agency, United Kingdom
First posted: 2005-09-05
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Apoptosis in colonic biopsy samples
Secondary outcomes:
measure: Cell proliferation
measure: lymphocyte infiltration
measure: circulating inflammatory markers (cytokines and prostaglandins)
measure: tissue inflammatory markers (cytokines and prostaglandins)
measure: faecal water cytotoxicity and genotoxicity
measure: gene transcription
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: University of Wageningen
city: Norwich
country: United Kingdom
facility: Institute of Food Research
state: Norfolk
Study officials:
affiliation: Quadram Institute Bioscience
name: Elizabeth K Lund, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.