The effect of red meat consumption on the formation of N-nitroso compounds, a group of compounds which may be harmful to humans, in relation to colorectal cancer

ISRCTN	ISRCTN32977454
DOI	https://doi.org/10.1186/ISRCTN32977454
Protocol serial number	N/A
Sponsor	Maastricht University (Netherlands)
Funder	Maastricht University (Netherlands) - internal funding

Submission date: 15/11/2010
Registration date: 14/12/2010
Last edited: 14/12/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Theo de Kok
Scientific

Universiteitssingel 50
Maastricht
6229 ER
Netherlands

Phone	+31 (0)43 3881091
Email	t.dekok@grat.unimaas.nl

Study information

Primary study design	Interventional
Study design	Non-randomised interventional multicentre study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	A non-randomised controlled trial to compare the effect of colon inflammation in combination with a 7-day 300 grams/day red meat diet on the endogenous formation of potentially carcinogenic N-nitroso compounds in the colon of inflammatory bowel disease patients versus non-inflamed irritable bowel syndrome patients, in relation to colorectal cancer risk
Study objectives	We hypothesise that both colon inflammation and a diet high in red meat increase the endogenous formation of potentially carcinogenic N-nitroso compounds in the human colon and that these compounds increase the colorectal cancer risk, which could (partially) explain the increased colorectal cancer risk that is associated with inflammatory bowel disease and diets high in red meat. Inflammatory bowel disease is characterised by a chronic inflammation within the gastrointestinal tract, which, in case of ulcerative colitis, is present in the colon and rectum.
Ethics approval(s)	The Medical Ethical Approval Committee (METC) Atrium Orbis Zuyd in Heerlen approved on the 23rd January 2007 (ref: METC 04-P-04A; reg no: NL13359.096.06)
Health condition(s) or problem(s) studied	Inflammatory bowel disease; colorectal cancer risk
Intervention	Both inflammatory bowel disease patients and irritable bowel syndrome control patients participate in a 7-day dietary intervention in which 300 grams of red meat products (steak, etc) are consumed daily. Collection of colon biopsies by endoscopic examination, blood collection by venipuncture, and urine and faecal matter collection takes place at the beginning and the end of the dietary intervention.
Intervention type	Other
Primary outcome measure(s)	1. Whole genome gene expression modifications by microarray analysis (4x44K Agilent platform) 2. Apparent total nitroso compounds in faecal matter by thermal energy analysis 3. Faecal water genotoxicity (30 minute exposure to 10% faecal water) by comet assay analysis in the adenocarcinoma cell line Caco-2 All outcomes are measured at baseline and post intervention.
Key secondary outcome measure(s)	1. Calprotectin levels in faecal matter as a measure of inflammation 2. Analysis of food frequency questionnaires recorded during intervention period 3. Possible determination of N-nitroso compound levels by thermal energy analysis in urine and blood All outcomes are measured at baseline and post intervention.
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key inclusion criteria	1. Inflammatory bowel disease patients with an active form of ulcerative colitis with a moderate exacerbation of their disease and in whom the inflammation does not go beyond the flexure lienalis 2. Irritable bowel syndrome control patients with endoscopically proven absence of inflammation and adenomas 3. Participants of any age (above 18 years) and either sex are included
Key exclusion criteria	1. Inflammatory bowel disease patients with severe inflammation, including Crohn's disease and pancolitis 2. Irritable bowel syndrome control patients with medical complaints and/or use of anti-inflammatory medication
Date of first enrolment	23/01/2007
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

Universiteitssingel 50

Maastricht
6229 ER
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes