Chemoprevention of Colorectal Cancer: the Role of Non-digestible Carbohydrates

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.

Conditions

• Colorectal Cancer

Interventions

DIETARY_SUPPLEMENT

Maltodextrin and Amioca starch

12g 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

Hi-maize 260

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.

DIETARY_SUPPLEMENT

Polydextrose

12g 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

Hi-maize 260 and polydextrose

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.

Sponsors & Collaborators

• Northumbria Healthcare NHS Foundation Trust

  collaborator OTHER

• Newcastle University

  lead OTHER

Principal Investigators

• John Mathers, PhD · Newcastle University

• Naomi Willis, PhD · Newcastle University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

16 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2012-06-30

Completion

2012-12-31

Countries

• United Kingdom

Study Locations