Protein acetylation as a diet-modifiable biomarker of colorectal cancer risk
ISRCTN | ISRCTN90852168 |
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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
Scientific
Human Nutrition Unit
School of Medicine & Biomedical Sciences
The University of Sheffield
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
Study information
Study design | Interventional single-centre non-randomised non-controlled cross-section trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/07/2006 |
Completion date | 30/09/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
Human Nutrition Unit
Sheffield
S10 2RX
United Kingdom
S10 2RX
United Kingdom
Sponsor information
University of Sheffield (UK)
University/education
University/education
Research Office
Research Services
New Spring House
231 Glossop Road
Sheffield
S10 2GW
England
United Kingdom
Website | http://www.sheffield.ac.uk/ |
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https://ror.org/05krs5044 |
Funders
Funder type
Government
Food Standards Agency (UK) (ref: N12017)
Private sector organisation / Other non-profit organizations
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
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 | |
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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? |
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Protocol article | protocol | 18/09/2009 | Yes | No | |
Results article | results | 17/04/2015 | Yes | No |
Editorial Notes
11/01/2018: publication reference added.