Protein acetylation as a diet-modifiable biomarker of colorectal cancer risk

ISRCTN ISRCTN90852168
DOI https://doi.org/10.1186/ISRCTN90852168
Secondary identifying numbers N12017
Submission date
08/04/2009
Registration date
04/08/2009
Last edited
11/01/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Bernard Corfe
Scientific

Human Nutrition Unit
School of Medicine & Biomedical Sciences
The University of Sheffield
Beech Hill Road
Sheffield
S10 2RX
United Kingdom

Study information

Study designInterventional single-centre non-randomised non-controlled cross-section trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleProtein acetylation as a diet-modifiable biomarker of colorectal cancer risk: an interventional single-centre cross-section trial
Study acronymThe FACT study
Study objectivesWe hypothesise that the reduced risk of colorectal cancer through increased fibre intake is mediated in part through changes in global protein acetylation.
Ethics approval(s)North Sheffield Ethics Committee gave approval on the 11th October 2006 (ref: 06/Q2308/93)
Health condition(s) or problem(s) studiedColorectal cancer/bowel health
InterventionVolunteers with a low habitual consumption of non-starch polysaccharides (NSP) and resistant starch (RS) will be recruited to an 8-week high fibre intervention trial. Volunteers will be provided with a range of high-fibre food options, with the goal of reaching 20 g per day fibre intake.
Intervention typeOther
Primary outcome measureAltered faecal short chain fatty acid (SCFA) production.

In the cross-sectional arm there is a single sampling timepoint and all primary and secondary measures are made at this point. For the intervention arm sampling is performed at baseline and after 8 weeks of intervention.
Secondary outcome measures1. Altered bowel crypt cytokinetics (proliferation, apoptosis and apoptosis regulators)
2. Identification of candidate biomarker acetylations

In the cross-sectional arm there is a single sampling timepoint and all primary and secondary measures are made at this point. For the intervention arm sampling is performed at baseline and after 8 weeks of intervention.
Overall study start date01/07/2006
Completion date30/09/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants140
Key inclusion criteria1. Aged 40 years and above, either sex for interventional arm and male only for cross-sectional arm
2. Adenoma, normal or cancer colon (30 of each group)
3. Body mass index (BMI) between 20 and 29 kg/m^2
Key exclusion criteria1. Severe medical or psychiatric illness
2. Unable to understand or communicate effectively
Date of first enrolment01/07/2006
Date of final enrolment30/09/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Human Nutrition Unit
Sheffield
S10 2RX
United Kingdom

Sponsor information

University of Sheffield (UK)
University/education

Research Office
Research Services
New Spring House
231 Glossop Road
Sheffield
S10 2GW
England
United Kingdom

Website http://www.sheffield.ac.uk/
ROR logo "ROR" https://ror.org/05krs5044

Funders

Funder type

Government

Food Standards Agency (UK) (ref: N12017)
Private sector organisation / Other non-profit organizations
Alternative name(s)
The Food Standards Agency, FSA
Location
United Kingdom
Biotechnology and Biological Sciences Research Council (BBSRC) (UK) (ref: BB/D 004187/1)
Government organisation / National government
Alternative name(s)
UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 18/09/2009 Yes No
Results article results 17/04/2015 Yes No

Editorial Notes

11/01/2018: publication reference added.