None listed
Conditions
Brief summary
This study will explore the potential of synbiotic combination of probiotic bacteria and resistant starch (RS) to improve health and reduce the risk of colon cancer. Participants will be asked to include in their diet either resistant starch or a probiotic or a combination of the two. Markers of the health value of these dietary agents will then be examined in samples of faeces, blood and samples taken from the lining of the bowel wall. Since the greatest risk of CRC is due to lifestyle (in particular diet) rather than genetic predisposition (family/hereditary bias), defining the disease mechanism and finding ways to prevent its occurrence are of significant importance. The proposed study will help provide valuable information on how resistant starch can be used to improve colon health, provide data on the prebiotic use of resistant starch and detailed information on a “synbiotic formulation” that is already on the market. The study participants (subjects) and the data analyst will be blinded. The probiotic bacteria will be in the form of boxes of capsules labelled - B The resistant starch will be in powder form in sachets labelled - A The combination will be A + B The resistant starch placebo will be labelled - C The placebo probiotic will be labelled - D Example: Pt 1 will be allocated with First 4 weeks A+B, then A and then final 4 weeks B Their boxes and sachets will be labelled A+B, A+D & B+C respectively.
Interventions
The aim of this study is to test the capacity of a synbiotic (Hi-maize resistant starch + Bifidobacteria) administered in the diet to humans for improving the biomarkers associated with bowel health and reducing the potential risk of colorectal cancer.
We will enlist 20 people in a random cross over design with an initial wash out period of 4 weeks (with no consumption of 'over the counter' products of Resistant Starch or Bifidobacteria) followed by three treatment phases, using the following v
The aim of this study is to test the capacity of a synbiotic (Hi-maize resistant starch + Bifidobacteria) administered in the diet to humans for improving the biomarkers associated with bowel health and reducing the potential risk of colorectal cancer. We will enlist 20 people in a random cross over design with an initial wash out period of 4 weeks (with no consumption of 'over the counter' products of Resistant Starch or Bifidobacteria) followed by three treatment phases, using the following variables: Synbiotic – resistant starch (RS) + Bifidobacteria. 4 wks Probiotic only – Bifidobacteria. 4 wks Prebiotic only - resistant starch. 4 wks
Sponsors
Professor Graeme Young MD, FRACP
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Healthy, with no active bowel disease, or with a previous history of adenoma removal.
Exclusion criteria
Evidence of any active mucosal bowel disease, eg colitis, or of malabsorption.Intolerance to high-fibre foods. Any perceived contraindication to consumption of the test products.
Outcome results
None listed