Colorectal CancerNCT00145015
FishGastro Study: Fish Consumption and Gastro-Intestinal Health
A study testing Increased dietary intake of salmon or cod in people with Colorectal Cancer and Ulcerative Colitis, run by Quadram Institute Bioscience at 2 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Ulcerative Colitis, Polyps
- What is being tested?
- Increased dietary intake of salmon or cod
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 270 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2004to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Institute of Food Research
Norwich, Norfolk, NR4 7UA
About this study
Official title: Fish Consumption and Gastro-Intestinal Health With Special Emphasis on Reduction of Risk of Colon Cancer and Inflammatory Bowel Disease
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.
- Conditions
- Colorectal Cancer, Ulcerative Colitis, Polyps
- Being tested
- Increased dietary intake of salmon or cod
- Keywords
- Intervention, Adults, Colorectal cancer, Nutrition, Fish, n-3 fatty acids, Apoptosis, Ulcerative colitis, Polyps, Gastro-intestinal tract
- Medical subject headings
- Colorectal Neoplasms, Colitis, Ulcerative, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased dietary intake of salmon or codBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Apoptosis in colonic biopsy samples
Secondary outcomes (6)
Cell proliferation
lymphocyte infiltration
circulating inflammatory markers (cytokines and prostaglandins)
tissue inflammatory markers (cytokines and prostaglandins)
faecal water cytotoxicity and genotoxicity
gene transcription
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startDec 2004
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University, University of Jena, University of East Anglia, European Commission, Food Standards Agency, United Kingdom
- Investigators
- Elizabeth K Lund, PhD, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145015
- Sponsor's protocol ID
- IFR02/2004
- Status last verified
- Jul 2008
- First submitted
- 1 Sep 2005
- Last updated
- 30 Jul 2008
- Results posted
- No
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 20032491Pot 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Consumption and Gastro-Intestinal Health With Special Emphasis on Reduction of Risk of Colon Cancer and Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT00145015
- Acronym / sponsor ID
- IFR02/2004
- Conditions
- Colorectal Cancer, Ulcerative Colitis, Polyps
- Keywords
- Intervention, Adults, Colorectal cancer, Nutrition, Fish, n-3 fatty acids, Apoptosis, Ulcerative colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- Wageningen University, University of Jena, University of East Anglia, European Commission, Food Standards Agency, United Kingdom
- Study start
- Dec 2004
- Study completion
- Apr 2008 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (13 listed)
- Allergic to fish
- Receiving anticoagulant therapy
- Diabetics
- Pregnant or breast-feeding
- Organ transplant recipients receiving immunosuppression therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increased dietary intake of salmon or cod | Behavioural | – |
Primary outcome
Apoptosis in colonic biopsy samples
6 secondary outcomes
Cell proliferation
lymphocyte infiltration
circulating inflammatory markers (cytokines and prostaglandins)
tissue inflammatory markers (cytokines and prostaglandins)
faecal water cytotoxicity and genotoxicity
gene transcription
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2008.
- Derived from this study: PubMed 20032491Pot 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.
- Derived from this study: PubMed 19553301Pot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth K Lund, PhD principal investigator
Quadram Institute Bioscience
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased dietary intake of salmon or cod in people with Colorectal Cancer and Ulcerative Colitis, run by Quadram Institute Bioscience at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apoptosis in colonic biopsy samples. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00145015, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2008; AzTrials last refreshed its copy on 6 Nov 2026.