The effects of butyrylated high amylose maize starch (Starplus B) on polyposis in familial adenomatous polyposis patients
A double blind, placebo controlled, randomised cross over trial to evaluate a novel and cost effective food supplement, butyrylated starch, on polyposis in familial adenomatous polyposis (FAP) patients.
Royal Melbourne Hospital
64 participants
Jan 9, 2014
Interventional
Conditions
Summary
The aim of this clinical trial is to determine whether a novel starch (butyrylated high amylose maize starch, Starplus B) can protect against colorectal cancer. Butyrate is normally produced in the colon by the fermentation of dietary fibre, and Starplus B can increase the concentration of butyrate in the colon. Laboratory and animal experiments suggest butyrate from dietary Starplus B may reduce the risk of developing colon cancer. The study is a double blind, randomised controlled trial involving 120 volunteers likely to develop a genetic form of colon cancer (familial adenomatosis polyposis, FAP). FAP patients usually have most of their colon surgically removed by their early 20’s, and require regular follow-up colonoscopies to ensure they do not develop tumours in their residual rectum. After a baseline colonoscopy the FAP volunteers consume either Starplus B or placebo starch for 6 months, and then undergo a colonoscopy to assess the number and size of polyps and to sample the lining of the colon for analysis. The volunteers then consume the other starch for 6 months, and undergo a further colonoscopy. As the FAP gene mutation also occurs in the majority of sporadic (common) colorectal cancer, the study may identify a dietary chemo-preventative supplement which is likely to benefit the wider community who are at risk of developing sporadic colorectal cancer.
Eligibility
Inclusion Criteria4
- Medically diagnosed FAP with either an intact colon, or after colectomy with a residual ileorectal anastomosis (IRA) or ileal pouch
- History of polyp detection at surveillance sigmoidoscopies or colonoscopies
- Generally in good health
- Available for the duration of the study
Exclusion Criteria7
- Intolerant to high fibre products
- Reported lactating, pregnant or wish to become pregnant during the study. If a participant becomes pregnant during the trial they will be withdrawn
- Reported use of nonsteroidal anti-inflammatory drugs, aspirin or probiotics
- Use of other medication or supplement that in the opinion of the gastroenterologist may interfere with polyp development or bowel or microbiota function for 2 months prior to and during the clinical intervention. Use of anti-diarrhoeal medication(s) is allowed as required
- Use of antibiotics for 2 months prior to the commencement of the trial
- Use of other experimental chemopreventative agents, including EPA, tumeric and curcumin for 6 months prior to and during the trial
- Colonic or rectal surgery likely within 18 months.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
This study recruited participants with Familial Adenomatous Polyposis (FAP). The trial is a double blind, placebo controlled, randomised cross over trial to evaluate a novel and cost effective food supplement, butyrylated high amylose maize starch (HAMSB), compared to a control starch, low amylose maize starch (LAMS), on polyposis in FAP patients. The starches (20g dose size) were ingested orally, twice per day, by way of combination with food for 6 months duration. The daily dose of HAMSB and LAMS is 40g/day. Following a baseline colonoscopy/sigmoidoscopy and biopsy collection, participants consumed either HAMSB or placebo (LAMS) for 6 months (+/- 2 weeks) then under went another colonoscopy/sigmoidoscopy examination and biopsy collection before crossing over to the alternate starch for 6 months. The second intervention also concluded with a colonoscopy/ sigmoidoscopy with biopsies. Participants then consumed their normal diet for a further 6 months with no intervention and at the end of this period a final colonscopy/sigmoidoscopy and biopsy was performed.
Locations(5)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12612000804886