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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Universiteitssingel 50
Maastricht
6229 ER
Netherlands
| Phone | +31 (0)43 3881091 |
|---|---|
| t.dekok@grat.unimaas.nl |
Study information
| Study design | Non-randomised interventional multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 23/01/2007 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 participants in total, of whom 40 inflammatory bowel disease (ulcerative colitis) patients and 40 control patients with irritable bowel syndrome. |
| 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
6229 ER
Netherlands
Sponsor information
Maastricht University (Netherlands)
University/education
University/education
Universiteitssingel 50
Maastricht
6229 ER
Netherlands
| Phone | +31 (0)43 3881091 |
|---|---|
| t.dekok@grat.unimaas.nl | |
| Website | http://www.maastrichtuniversity.nl/ |
"ROR" |
https://ror.org/02jz4aj89 |
Funders
Funder type
University/education
Maastricht University (Netherlands) - internal funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
