Clinical trial · Interventional
Chemoprevention of Colorectal Cancer: the Role of Non-digestible Carbohydrates
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hi-maize 260 | Dietary Supplement | — | UNRESOLVED |
| Hi-maize 260 and polydextrose | Dietary Supplement | — | UNRESOLVED |
| Maltodextrin and Amioca starch | Dietary Supplement | — | UNRESOLVED |
| Polydextrose | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Dietary Supplement: Maltodextrin and Amioca starch
- type
- EXPERIMENTAL
- label
- Hi-maize 260
- interventionNames
- Dietary Supplement: Hi-maize 260
- type
- EXPERIMENTAL
- label
- Polydextrose
- interventionNames
- Dietary Supplement: Polydextrose
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: Attended for flexible sigmoidoscopy or colonoscopy and no macroscopic pathology identified Exclusion Criteria: * Age \<16 or \>85 * Familial polyposis syndrome * Lynch syndrome * Known colorectal tumour * Previous colorectal resection * Pregnancy * 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
References
Publications (7)
- RESULTAsp 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. PMID 19094263
- RESULTAuerbach 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. PMID 18236693
- RESULTWachtershauser 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. PMID 11079736
- RESULTDronamraju 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. PMID 18978177
- DERIVEDFan 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. PMID 42489745
- DERIVEDMalcomson 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. PMID 28418082
- DERIVEDMalcomson 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.