Condition category
Cancer
Date applied
22/09/2005
Date assigned
04/11/2005
Last edited
10/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof John Mathers

ORCID ID

Contact details

Human Nutrition Research Centre
University of Newcastle
Newcastle Upon Tyne
NE2 8NH
United Kingdom
+44 (0)191 228487
john.mathers@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To test the hypothesis that individuals with certain genetic make up (MLH1 gene* deficient) are more susceptible to the anti-cancer effects of Resistant Starch**.
* MLH1 gene is one of the DNA mismatch repair genes. These genes help to correct the errors during DNA replication.

** Resistant Starch is a part of our normal dietary intake. It is a type of starch which is resistant to the action of digestive enzymes in the small gut and hence reaches the large bowel undigested. These undigested starches are fermented by bacteria in the large bowel to form short chain fatty acids like butyrate, acetate and propionate.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colorectal cancer

Intervention

Colonic mucosal biopsies from tumour and normal mucosa will be obtained from all consented volunteers at the time of endoscopy. Then they will be randomised into two groups, one group will get resistant starch (30 g per day) and the second group will get ordinary starch (30 g per day) for a period of 2-4 weeks depending on the duration between diagnosis and the definitive surgery (colectomy). Post treatment samples from tumour and normal mucosa will be obtained from resected specimens.

Intervention type

Drug

Phase

Not Specified

Drug names

Resistant starch

Primary outcome measures

Difference in gene expression, cell proliferation and apoptosis in the pre treatment and post treatment samples and in patients with and without a functioning MLH1 gene.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2005

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All individuals who are found to have a colorectal lesion suspicious of malignancy which would require an elective operation at the time of colonoscopy/flexible sigmoidoscopy.
About 10%-12% of all sporadic colorectal cancers have defective MLH1 gene (Lothe RA, Cancer Res 1993). By recruiting all sporadic colorectal cancer patients we will have recruited individuals both with and without loss of function of the MLH1 gene and hence, we will be able test our hypothesis that the MLH1 gene influences response to Resistant Starch.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Patients who have had a subtotal colectomy with an ileorectal anastamosis (insufficient length of functioning large bowel for the resistant starch to have effect)
2. Patients with ileostomy or a diversion colostomy (resistant starch will not reach the colonic lumen)
3. Individuals who are not capable of giving their informed consent
4. Individuals who cannot continue taking the oral supplements for any reason
5. Pregnant women (effect of resistant starch in pregnant women and foetuses has not yet not evaluated)

Recruitment start date

01/07/2005

Recruitment end date

30/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Human Nutrition Research Centre
Newcastle Upon Tyne
NE2 8NH
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Trust (UK)

Sponsor details

North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
+44 (0)191 2596660
jackie.colligan@northumbria-healthcare.nhs.uk

Sponsor type

Government

Website

http://www.northumbria-healthcare.nhs.uk

Funders

Funder type

Research council

Funder name

The Biotechnology and Biological Sciences Research Council (BBSRC) (UK) - (Grant ref no.-13/D20173)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18978177

Publication citations

  1. Results

    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, 58, 3, 413-420, doi: 10.1136/gut.2008.162933.

Additional files

Editorial Notes