The effect of increased red meat consumption on the formation of N-nitroso compounds in ileostomists
| ISRCTN | ISRCTN55253115 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55253115 |
| Secondary identifying numbers | N0544112304 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 30/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Joanne Lunn
Scientific
Scientific
MRC Dunn Human Nutrition Unit
MRC/Wellcome Trust Building
Hills Road
Cambridge
CB2 2XY
United Kingdom
Study information
| Study design | Randomised controlled crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | What is the total N-nitroso compound content of the residue leaving the ileum following consumption of high and low red meat diets? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Ileostomy |
| Intervention | This is a randomised crossover study consisting of three dietary periods. 12 Non-smoking male or female free-living ileostomists will be recruited by advertisement in the newsletter/website of the Ileostomy Association. The study will last for 6 days, during which time volunteers will live at the volunteer suite at the MRC Dunn Human Nutrition Unit. The volunteers will recieve all three dietary interventions in a randomly assigned order. 1. 1x2 day high red meat diet (240 g red meat/day) 2. 1x2 day low red meat diet (60 g red meat/day) 3. 1x2 day no red meat control diet The diets will contain measured amounts of other types of food, for example bread and vegetables, to provide all the nutrients required. Each volunteer will be required to collect all ileal effluent produced for determination of apparent total N-nitroso compound, N-proline and N-nitroso myoglobin content. Liquid chromatography/Mass spectrometry (LC/MS) will also be used in an attempt to characterise the N-nitroso compounds further. Genotoxicity tests will be carried out on the effluent. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 17/05/2002 |
| Completion date | 16/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 12 |
| Key inclusion criteria | 12 Subjects in the age range of 20-85 years. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 17/05/2002 |
| Date of final enrolment | 16/05/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Dunn Human Nutrition Unit
Cambridge
CB2 2XY
United Kingdom
CB2 2XY
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Other
Cambridge Consortium - Addenbrookes (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2007 | Yes | No |
