Colorectal CancerNCT01214681
Chemoprevention of Colorectal Cancer: the Role of Non-digestible Carbohydrates
A study testing Maltodextrin and Amioca starch, Hi-maize 260 and Polydextrose in people with Colorectal Cancer, run by Newcastle University at 2 sites in United Kingdom.
Trial summary
Colorectal cancer is a common disease worldwide. It is now thought that colorectal cancer cells arise from stem cells where the genetic material regulating growth and division of the stem cell has become defective. Read more about this study
- Who is it for?
- Ages 16 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Maltodextrin and Amioca starch, Hi-maize 260 and Polydextrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Attended for flexible sigmoidoscopy or colonoscopy and no macroscopic pathology identified
Who cannot join
- Age <16 or >85
- Familial polyposis syndrome
- Lynch syndrome
- Known colorectal tumour
- Previous colorectal resection
- Pregnancy
Show all 18Show fewer
- Chemotherapy in last 6 months
- Therapy with aspirin/other NSAID
- Other immunosuppressive medication
- Active colonic inflammation at endoscopy
- Incomplete left sided examination
- Colorectal carcinoma found at endoscopy
- Iatrogenic perforation at endoscopy
- Colorectal cancer on histology
- Warfarin or other anticoagulant use
- Diabetes mellitus
- Crohn's disease
- Cognitive impairment
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Wansbeck General Hospital
Ashington, Northumberland, NE63 9JJ
North Tyneside General Hospital
North Shields, Tyne & Wear, NE29 8NH
About this study
Colorectal cancer is a common disease worldwide. It is now thought that colorectal cancer cells arise from stem cells where the genetic material regulating growth and division of the stem cell has become defective. This leads to unregulated production of cells which in turn have defective genetic information and cancer formation.
Research into colorectal cancer is hampered by the fact that studies must take a very long time to produce results and be very large if the development of a cancer is the endpoint. Therefore alternative methods of quantifying the risk of developing a cancer are required so trials can be a realistic size and be completed in a realistic time frame. The investigators have previously identified several candidates for these 'biomarkers'. The next stage in proving or disproving these as useful biomarkers is to test their response to a dietary agent that the investigators know reduces the risk of colon cancer.
Read the detailed description
This project is designed to enhance understanding of links between food and the health of the gut. The particular purpose of the project is to investigate the impact of a well-defined intervention in human volunteers on a panel of novel, and established, diet-related biomarkers of bowel cancer risk. We have developed a number of novel biomarkers of diet-related CRC risk measured in colo-rectal mucosal biopsies (and in stool). These biomarkers include differentially expressed proteins, DNA methylation markers and inflammation markers. In our on-going BORICC Study we are investigating the relationships between dietary exposure and nutritional status for these biomarkers in a cross-sectional study. The next logical step in this research is to determine whether a selected panel of the most promising biomarkers responds to a dietary intervention i.e. to test their utility as biomarkers of GI health and potential as surrogate endpoints in future human studies.
We propose to use Hi-maize 260 and polydextrose (PD) as our model resistant starch (RS) intervention agents. RS describes the fraction of dietary starch which is not digested in the small bowel and which flows to the colon where it is a substrate for bacterial fermentation. (Asp, 1996) PD is produced by the bulk melt polycondensation of glucose and sorbitol to produce an oligosaccharide with a mean degree of polymerisation of 12 which is resistant to mammalian GI enzymes and, like other RSs, is a substrate for bacterial fermentation. (Auerbach, 2007) Both Hi-maize and PD are fermented (to a greater or lesser extent) producing short-chain fatty acids (SCFA) including butyrate. (Asp, 1996) Butyrate has beneficial effects on gut physiology and immune function including anti-inflammatory effects. (Wächtershäuser, 2000; Dronamraju, 2009)
In the present project we will investigate the impact of PD and RS, as food-borne substrates for delivery of butyrate, on biomarkers of bowel cancer risk.
- Conditions
- Colorectal Cancer
- Being tested
- Maltodextrin and Amioca starch, Hi-maize 260, Polydextrose, Hi-maize 260 and polydextrose
- Keywords
- Biomarkers, Colorectal cancer, Resistant starch, Polydextrose, Non-digestible carbohydrate
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maltodextrin and Amioca starchDietary supplement
12g Maltodextrin and 23g Amioca starch daily in divided doses for 50 days. Provided as a powder to be added to food or drink.
Hi-maize 260Dietary supplement
23g Hi-maize 260 and 12g Maltodextrin daily in divided doses for 50 days. Provided as a powder to be added to food or drink.
PolydextroseDietary supplement
12g polydextrose and 23g amioca starch daily in divided doses for 50 days. Provided as a powder to be added to food or drink.
Hi-maize 260 and polydextroseDietary supplement
12g polydextrose and 23g Hi-maize 260 daily in divided doses for 50 days. Provided as a powder to be added to food or drink.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Maltodextrin and Amioca starch |
| Hi-maize 260 | Experimental | Not described Receives: Dietary Supplement: Hi-maize 260 |
| Polydextrose | Experimental | Not described Receives: Dietary Supplement: Polydextrose |
| Hi-maize 260 and polydextrose | Active comparator | Not described Receives: Dietary Supplement: Hi-maize 260 and polydextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faecal calprotectin concentration
Measured: 50 days
Secondary outcomes (13)
Serum C reactive protein concentration
Measured: 50 days
COX 2 expression in mucosal biopsies
Measured: 50 days
Number and distribution of mitotic and apoptotic cells within colonic crypts (mucosal cell kinetics)
Measured: 50 days
Cellular CDK 4 RNA expression
Measured: 50 days
Cellular GADD45A RNA expression
Measured: 50 days
Target gene methylation (p16, GSTP1, RARβ2, CDH1 GATA4 APC, SFRP1, 2, 4 and 5, AXIN2, DKK1 and WIF1)
Measured: 50 days
Global genetic methylation
Measured: 50 days
Cellular protein biomarker (CK8) expression
Measured: 50 days
Faecal pH
Measured: 50 days
Faecal bacterial abundance and population
Measured: 50 days
Faecal short chain fatty acid concentration
Measured: 50 days
Urinary short chain fatty acid concentration
Measured: 50 days
Plasma short chain fatty acid concentration
Measured: 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Northumbria Healthcare NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- John Mathers, PhD, Study director, Newcastle UniversityNaomi Willis, PhD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214681
- Sponsor's protocol ID
- 002
- Status last verified
- Oct 2011
- First submitted
- 1 Oct 2010
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Asp NG, van Amelsvoort JM, Hautvast JG. Nutritional implications of resistant starch. Nutr Res Rev. 1996 Jan;9(1):1-31. doi: 10.1079/NRR19960004. No abstract available.
PubMed 19094263Auerbach MH, Craig SA, Howlett JF, Hayes KC. Caloric availability of polydextrose. Nutr Rev. 2007 Dec;65(12 Pt 1):544-9. doi: 10.1301/nr.2007.dec.544-549.
PubMed 18236693Wachtershauser A, Stein J. Rationale for the luminal provision of butyrate in intestinal diseases. Eur J Nutr. 2000 Aug;39(4):164-71. doi: 10.1007/s003940070020.
PubMed 11079736Dronamraju SS, Coxhead JM, Kelly SB, Burn J, Mathers JC. Cell kinetics and gene expression changes in colorectal cancer patients given resistant starch: a randomised controlled trial. Gut. 2009 Mar;58(3):413-20. doi: 10.1136/gut.2008.162933. Epub 2008 Oct 31.
PubMed 18978177Fan J, le Gall G, Malcomson FC, Louca P, Beck L, Nelson A, Willis ND, McCallum I, Xie L, Ouwehand AC, Stowell JD, Kelly SB, Bradburn M, Belshaw NJ, Johnson IT, Stewart CJ, Muller M, Corfe BM, Mathers JC. Distinct effects of supplementation with resistant starch and polydextrose on plasma and faecal bile acid profile and associations with gut microbiota: a randomised, controlled intervention in healthy participants. Eur J Nutr. 2026 Jul 23;65(5):220. doi: 10.1007/s00394-026-04060-1.
PubMed 42489745Malcomson FC, Willis ND, McCallum I, Xie L, Lagerwaard B, Kelly S, Bradburn DM, Belshaw NJ, Johnson IT, Mathers JC. Non-digestible carbohydrates supplementation increases miR-32 expression in the healthy human colorectal epithelium: A randomized controlled trial. Mol Carcinog. 2017 Sep;56(9):2104-2111. doi: 10.1002/mc.22666. Epub 2017 May 9.
PubMed 28418082Malcomson FC, Willis ND, McCallum I, Xie L, Ibero-Baraibar I, Leung WC, Kelly S, Bradburn DM, Belshaw NJ, Johnson IT, Mathers JC. Effects of supplementation with nondigestible carbohydrates on fecal calprotectin and on epigenetic regulation of SFRP1 expression in the large-bowel mucosa of healthy individuals. Am J Clin Nutr. 2017 Feb;105(2):400-410. doi: 10.3945/ajcn.116.135657. Epub 2017 Jan 11.
PubMed 28077379
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoprevention of Colorectal Cancer: the Role of Non-digestible Carbohydrates
- ClinicalTrials.gov ID
- NCT01214681
- Acronym / sponsor ID
- 002
- Conditions
- Colorectal Cancer
- Keywords
- Biomarkers, Colorectal cancer, Resistant starch, Polydextrose, Non-digestible carbohydrate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Northumbria Healthcare NHS Foundation Trust
- Study start
- May 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer is a common disease worldwide. It is now thought that colorectal cancer cells arise from stem cells where the genetic material regulating growth and division of the stem cell has become defective. This leads to unregulated production of cells which in turn have defective genetic information and cancer formation.
Research into colorectal cancer is hampered by the fact that studies must take a very long time to produce results and be very large if the development of a cancer is the endpoint. Therefore alternative methods of quantifying the risk of developing a cancer are required so trials can be a realistic size and be completed in a realistic time frame. The investigators have previously identified several candidates for these 'biomarkers'. The next stage in proving or disproving these as useful biomarkers is to test their response to a dietary agent that the investigators know reduces the risk of colon cancer.
Detailed description
This project is designed to enhance understanding of links between food and the health of the gut. The particular purpose of the project is to investigate the impact of a well-defined intervention in human volunteers on a panel of novel, and established, diet-related biomarkers of bowel cancer risk. We have developed a number of novel biomarkers of diet-related CRC risk measured in colo-rectal mucosal biopsies (and in stool). These biomarkers include differentially expressed proteins, DNA methylation markers and inflammation markers. In our on-going BORICC Study we are investigating the relationships between dietary exposure and nutritional status for these biomarkers in a cross-sectional study. The next logical step in this research is to determine whether a selected panel of the most promising biomarkers responds to a dietary intervention i.e. to test their utility as biomarkers of GI health and potential as surrogate endpoints in future human studies.
We propose to use Hi-maize 260 and polydextrose (PD) as our model resistant starch (RS) intervention agents. RS describes the fraction of dietary starch which is not digested in the small bowel and which flows to the colon where it is a substrate for bacterial fermentation. (Asp, 1996) PD is produced by the bulk melt polycondensation of glucose and sorbitol to produce an oligosaccharide with a mean degree of polymerisation of 12 which is resistant to mammalian GI enzymes and, like other RSs, is a substrate for bacterial fermentation. (Auerbach, 2007) Both Hi-maize and PD are fermented (to a greater or lesser extent) producing short-chain fatty acids (SCFA) including butyrate. (Asp, 1996) Butyrate has beneficial effects on gut physiology and immune function including anti-inflammatory effects. (Wächtershäuser, 2000; Dronamraju, 2009)
In the present project we will investigate the impact of PD and RS, as food-borne substrates for delivery of butyrate, on biomarkers of bowel cancer risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin and Amioca starch |
| Hi-maize 260 | Experimental | Dietary Supplement: Hi-maize 260 |
| Polydextrose | Experimental | Dietary Supplement: Polydextrose |
| Hi-maize 260 and polydextrose | Active comparator | Dietary Supplement: Hi-maize 260 and polydextrose |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Attended for flexible sigmoidoscopy or colonoscopy and no macroscopic pathology identified
Key exclusion criteria (18 listed)
- Age <16 or >85
- Familial polyposis syndrome
- Lynch syndrome
- Known colorectal tumour
- Previous colorectal resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maltodextrin and Amioca starch12g Maltodextrin and 23g Amioca starch daily in divided doses for 50 days. Provided as a powder to be added to food or drink. | Dietary supplement | Placebo |
| Hi-maize 26023g Hi-maize 260 and 12g Maltodextrin daily in divided doses for 50 days. Provided as a powder to be added to food or drink. | Dietary supplement | Hi-maize 260 |
| Polydextrose12g polydextrose and 23g amioca starch daily in divided doses for 50 days. Provided as a powder to be added to food or drink. | Dietary supplement | Polydextrose |
| Hi-maize 260 and polydextrose12g polydextrose and 23g Hi-maize 260 daily in divided doses for 50 days. Provided as a powder to be added to food or drink. | Dietary supplement | Hi-maize 260 and polydextrose |
Primary outcome
Faecal calprotectin concentration
Time frame: 50 days
13 secondary outcomes
Serum C reactive protein concentration
Time frame: 50 days
COX 2 expression in mucosal biopsies
Time frame: 50 days
Number and distribution of mitotic and apoptotic cells within colonic crypts (mucosal cell kinetics)
Time frame: 50 days
Cellular CDK 4 RNA expression
Time frame: 50 days
Cellular GADD45A RNA expression
Time frame: 50 days
Target gene methylation (p16, GSTP1, RARβ2, CDH1 GATA4 APC, SFRP1, 2, 4 and 5, AXIN2, DKK1 and WIF1)
Time frame: 50 days
Global genetic methylation
Time frame: 50 days
Cellular protein biomarker (CK8) expression
Time frame: 50 days
Faecal pH
Time frame: 50 days
Faecal bacterial abundance and population
Time frame: 50 days
Faecal short chain fatty acid concentration
Time frame: 50 days
Urinary short chain fatty acid concentration
Time frame: 50 days
Plasma short chain fatty acid concentration
Time frame: 50 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
- Results publication: PubMed 19094263Asp NG, van Amelsvoort JM, Hautvast JG. Nutritional implications of resistant starch. Nutr Res Rev. 1996 Jan;9(1):1-31. doi: 10.1079/NRR19960004. No abstract available.
- Results publication: PubMed 18236693Auerbach MH, Craig SA, Howlett JF, Hayes KC. Caloric availability of polydextrose. Nutr Rev. 2007 Dec;65(12 Pt 1):544-9. doi: 10.1301/nr.2007.dec.544-549.
- Results publication: PubMed 11079736Wachtershauser A, Stein J. Rationale for the luminal provision of butyrate in intestinal diseases. Eur J Nutr. 2000 Aug;39(4):164-71. doi: 10.1007/s003940070020.
- Results publication: PubMed 18978177Dronamraju SS, Coxhead JM, Kelly SB, Burn J, Mathers JC. Cell kinetics and gene expression changes in colorectal cancer patients given resistant starch: a randomised controlled trial. Gut. 2009 Mar;58(3):413-20. doi: 10.1136/gut.2008.162933. Epub 2008 Oct 31.
- Derived from this study: PubMed 42489745Fan J, le Gall G, Malcomson FC, Louca P, Beck L, Nelson A, Willis ND, McCallum I, Xie L, Ouwehand AC, Stowell JD, Kelly SB, Bradburn M, Belshaw NJ, Johnson IT, Stewart CJ, Muller M, Corfe BM, Mathers JC. Distinct effects of supplementation with resistant starch and polydextrose on plasma and faecal bile acid profile and associations with gut microbiota: a randomised, controlled intervention in healthy participants. Eur J Nutr. 2026 Jul 23;65(5):220. doi: 10.1007/s00394-026-04060-1.
- Derived from this study: PubMed 28418082Malcomson FC, Willis ND, McCallum I, Xie L, Lagerwaard B, Kelly S, Bradburn DM, Belshaw NJ, Johnson IT, Mathers JC. Non-digestible carbohydrates supplementation increases miR-32 expression in the healthy human colorectal epithelium: A randomized controlled trial. Mol Carcinog. 2017 Sep;56(9):2104-2111. doi: 10.1002/mc.22666. Epub 2017 May 9.
- Derived from this study: PubMed 28077379Malcomson FC, Willis ND, McCallum I, Xie L, Ibero-Baraibar I, Leung WC, Kelly S, Bradburn DM, Belshaw NJ, Johnson IT, Mathers JC. Effects of supplementation with nondigestible carbohydrates on fecal calprotectin and on epigenetic regulation of SFRP1 expression in the large-bowel mucosa of healthy individuals. Am J Clin Nutr. 2017 Feb;105(2):400-410. doi: 10.3945/ajcn.116.135657. Epub 2017 Jan 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Mathers, PhD study director
Newcastle University
Naomi Willis, PhD principal investigator
Newcastle University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maltodextrin and Amioca starch, Hi-maize 260 and Polydextrose in people with Colorectal Cancer, run by Newcastle University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faecal calprotectin concentration (time frame: 50 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01214681, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2011.