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

ISRCTN	ISRCTN90852168
DOI	https://doi.org/10.1186/ISRCTN90852168
Protocol serial number	N12017
Sponsor	University of Sheffield (UK)
Funders	Food Standards Agency (UK) (ref: N12017), Biotechnology and Biological Sciences Research Council (BBSRC) (UK) (ref: BB/D 004187/1)

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

Primary study design	Interventional
Study design	Interventional single-centre non-randomised non-controlled cross-section trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Protein acetylation as a diet-modifiable biomarker of colorectal cancer risk: an interventional single-centre cross-section trial
Study acronym	The FACT study
Study objectives	We 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) studied	Colorectal cancer/bowel health
Intervention	Volunteers 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 type	Other
Primary outcome measure(s)	Altered 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.
Key secondary outcome measure(s)	1. 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.
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	140
Key inclusion criteria	1. 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 criteria	1. Severe medical or psychiatric illness 2. Unable to understand or communicate effectively
Date of first enrolment	01/07/2006
Date of final enrolment	30/09/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Human Nutrition Unit

Sheffield
S10 2RX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/04/2015		Yes	No
Protocol article	protocol	18/09/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/01/2018: publication reference added.