NCT01214681

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started May 2010

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 26, 2011

Status Verified

October 1, 2011

Enrollment Period

2.1 years

First QC Date

October 1, 2010

Last Update Submit

October 25, 2011

Conditions

Colorectal Cancer

Keywords

BiomarkersColorectal cancerResistant starchPolydextroseNon-digestible carbohydrate

Outcome Measures

Primary Outcomes (1)

  • Faecal calprotectin concentration

    50 days

Secondary Outcomes (13)

  • Serum C reactive protein concentration

    50 days

  • COX 2 expression in mucosal biopsies

    50 days

  • Number and distribution of mitotic and apoptotic cells within colonic crypts (mucosal cell kinetics)

    50 days

  • Cellular CDK 4 RNA expression

    50 days

  • Cellular GADD45A RNA expression

    50 days

  • +8 more secondary outcomes

Study Arms (4)

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

Interventions

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.

Placebo
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.

Hi-maize 260
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.

Polydextrose
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.

Hi-maize 260 and polydextrose

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Attended for flexible sigmoidoscopy or colonoscopy and no macroscopic pathology identified

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wansbeck General Hospital

Ashington, Northumberland, NE63 9JJ, United Kingdom

Location

North Tyneside General Hospital

North Shields, Tyne & Wear, NE29 8NH, United Kingdom

Location

Related Publications (6)

  • 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.

    PMID: 19094263RESULT

  • Auerbach 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: 18236693RESULT

  • Wachtershauser 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: 11079736RESULT

  • Dronamraju 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: 18978177RESULT

  • Malcomson 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: 28418082DERIVED

  • Malcomson 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.

    PMID: 28077379DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

maltodextrinhigh-amylose maize type 2 resistant starch, maizepolydextrose

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • John Mathers, PhD

    Newcastle University

    STUDY DIRECTOR

  • Naomi Willis, PhD

    Newcastle University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 5, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

October 26, 2011

Record last verified: 2011-10

Locations

GB(2)