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CompletedNCT00145015Updated Jul 30, 2008

FishGastro Study: Fish Consumption and Gastro-Intestinal Health

An interventional study of Increased dietary intake of salmon or cod in Colorectal Cancer, Ulcerative Colitis and Polyps, sponsored by Quadram Institute Bioscience. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-07-30.

Sponsored by Quadram Institute Bioscience · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Cancer
  • Ulcerative Colitis
  • Polyps

Keywords

  • Intervention
  • Adults
  • Colorectal cancer
  • Nutrition
  • Fish
  • n-3 fatty acids
  • Apoptosis
  • Ulcerative colitis
  • Polyps
  • Gastro-intestinal tract
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 270 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Quadram Institute Bioscience is the lead sponsor of 44 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
270 participants (estimated)

Interventions

  • BehavioralIncreased dietary intake of salmon or cod
06

What researchers measure

Primary outcomes

  1. Apoptosis in colonic biopsy samples

Secondary outcomes

  1. Cell proliferation

  2. lymphocyte infiltration

  3. circulating inflammatory markers (cytokines and prostaglandins)

  4. tissue inflammatory markers (cytokines and prostaglandins)

  5. faecal water cytotoxicity and genotoxicity

  6. gene transcription

07

Study locations

2 sites
  • University of Wageningen
    Wageningen, Netherlands
  • Institute of Food Research
    Norwich, Norfolk NR4 7UA, United Kingdom
08

References and documents

Publications

  • 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. PubMed 20032491 ↗
  • 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. PubMed 19553301 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2004 and a completion of Apr 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2005
First posted
Sep 5, 2005
Start
Dec 2004
CompletionActual
Apr 2008
Last update
Jul 30, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00145015
Lead sponsor
Quadram Institute Bioscience
Collaborators
Wageningen University, University of Jena, University of East Anglia, European Commission, Food Standards Agency, United Kingdom
First posted
Sep 5, 2005
Start date
Dec 2004
Completion
Apr 2008
Last update
Jul 30, 2008

Study contacts

Elizabeth K Lund, PhD
principal investigator · Quadram Institute Bioscience
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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