NCT00145015

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Dec 2004

Typical duration for not_applicable colorectal-cancer

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

July 30, 2008

Status Verified

July 1, 2008

First QC Date

September 1, 2005

Last Update Submit

July 29, 2008

Conditions

Colorectal CancerUlcerative ColitisPolyps

Keywords

InterventionAdultsColorectal cancerNutritionFishn-3 fatty acidsApoptosisUlcerative colitisPolypsGastro-intestinal tract

Outcome Measures

Primary Outcomes (1)

  • 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

  • +1 more secondary outcomes

Interventions

Increased dietary intake of salmon or codBEHAVIORAL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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):
  • +5 more criteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Wageningen

Wageningen, Netherlands

Location

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 20032491DERIVED

  • 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.

    PMID: 19553301DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsColitis, UlcerativePolyps

Interventions

CVD protocol

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesColitisGastroenteritisInflammatory Bowel DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth K Lund, PhD

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

December 1, 2004

Study Completion

April 1, 2008

Last Updated

July 30, 2008

Record last verified: 2008-07

Locations

NL(1)GB(1)