Influence of MLH1 gene on anti-neoplastic effects of Resistant Starch
| ISRCTN | ISRCTN93586244 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93586244 |
| Protocol serial number | N/A |
| Sponsor | Northumbria Healthcare NHS Trust (UK) |
| Funder | The Biotechnology and Biological Sciences Research Council (BBSRC) (UK) - (Grant ref no.-13/D20173) |
- Submission date
- 22/09/2005
- Registration date
- 04/11/2005
- Last edited
- 10/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof John Mathers
Scientific
Scientific
Human Nutrition Research Centre
University of Newcastle
Newcastle Upon Tyne
NE2 8NH
United Kingdom
| Phone | +44 (0)191 228487 |
|---|---|
| john.mathers@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Resistant starch |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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. |
| Key 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) |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Human Nutrition Research Centre
Newcastle Upon Tyne
NE2 8NH
United Kingdom
NE2 8NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2009 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
