Condition category
Cancer
Date applied
08/04/2009
Date assigned
04/08/2009
Last edited
28/09/2009
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

Dr Bernard Corfe

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N12017

Study information

Scientific title

Protein acetylation as a diet-modifiable biomarker of colorectal cancer risk: an interventional single-centre cross-section trial

Acronym

The FACT study

Study hypothesis

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

North Sheffield Ethics Committee gave approval on the 11th October 2006 (ref: 06/Q2308/93)

Study design

Interventional single-centre non-randomised non-controlled cross-section trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/07/2006

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant exclusion criteria

1. Severe medical or psychiatric illness
2. Unable to understand or communicate effectively

Recruitment start date

01/07/2006

Recruitment end date

30/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Human Nutrition Unit
Sheffield
S10 2RX
United Kingdom

Sponsor information

Organisation

University of Sheffield (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.sheffield.ac.uk/

Funders

Funder type

Government

Funder name

Food Standards Agency (UK) (ref: N12017)

Alternative name(s)

FSA

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Biotechnology and Biological Sciences Research Council (BBSRC) (UK) (ref: BB/D 004187/1)

Alternative name(s)

BBSRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19765278

Publication citations

  1. Protocol

    Corfe BM, Williams EA, Bury JP, Riley SA, Croucher LJ, Lai DY, Evans CA, A study protocol to investigate the relationship between dietary fibre intake and fermentation, colon cell turnover, global protein acetylation and early carcinogenesis: the FACT study., BMC Cancer, 2009, 9, 332, doi: 10.1186/1471-2407-9-332.

Additional files

Editorial Notes