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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32977454

Enrollment

Registered

2010-12-14

Start date

2007-01-23

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease

Interventions

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 dai

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026