Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Joanne Lunn

ORCID ID

Contact details

MRC Dunn Human Nutrition Unit
MRC/Wellcome Trust Building
Hills Road
Cambridge
CB2 2XY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544112304

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

17/05/2002

Overall trial end date

16/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

12 Subjects in the age range of 20-85 years.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

17/05/2002

Recruitment end date

16/05/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Dunn Human Nutrition Unit
Cambridge
CB2 2XY
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Other

Funder name

Cambridge Consortium - Addenbrookes (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17052997

Publication citations

  1. Results

    Lunn JC, Kuhnle G, Mai V, Frankenfeld C, Shuker DE, Glen RC, Goodman JM, Pollock JR, Bingham SA, The effect of haem in red and processed meat on the endogenous formation of N-nitroso compounds in the upper gastrointestinal tract., Carcinogenesis, 2007, 28, 3, 685-690, doi: 10.1093/carcin/bgl192.

Additional files

Editorial Notes