Study Summary
This trial will test whether a high-dose soluble fiber supplement, given as a drink, can reduce the Ki67 proliferative colonic mucosal biomarkers of cancer risk in Alaska native people, who have the highest recorded incidence and death rate from colon cancer in the world.
- Colon Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 4 weeks
Trial Safety
Phase-Based Safety
Trial Design
2 Treatment Groups
Resistant Starch
1 of 2
Digestible Starch
1 of 2
Active Control
Non-Treatment Group
48 Total Participants · 2 Treatment Groups
Primary Treatment: Resistant Starch · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 40 - 70 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- O'Keefe, Stephen J. D.. 2016. “Diet, Microorganisms and Their Metabolites, and Colon Cancer”. Nature Reviews Gastroenterology & Hepatology. Springer Science and Business Media LLC. doi:10.1038/nrgastro.2016.165.
- Koller, Kathryn R, Annette Wilson, Daniel P Normolle, Jeremy K Nicholson, Jia V Li, James Kinross, Flora R Lee, et al.. 2021. “Dietary Fibre to Reduce Colon Cancer Risk in Alaska Native People: The Alaska FIRST Randomised Clinical Trial Protocol”. BMJ Open. BMJ. doi:10.1136/bmjopen-2020-047162.
- O’Keefe, Stephen J. D., Jia V. Li, Leo Lahti, Junhai Ou, Franck Carbonero, Khaled Mohammed, Joram M. Posma, et al.. 2015. “Fat, Fibre and Cancer Risk in African Americans and Rural Africans”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/ncomms7342.
- Ou, Junhai, Franck Carbonero, Erwin G Zoetendal, James P DeLany, Mei Wang, Keith Newton, H Rex Gaskins, and Stephen JD O’Keefe. 2013. “Diet, Microbiota, and Microbial Metabolites in Colon Cancer Risk in Rural Africans and African Americans”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.3945/ajcn.112.056689.
- Koller, Kathryn R, Annette Wilson, Daniel P Normolle, Jeremy K Nicholson, Jia V Li, James Kinross, Flora R Lee, et al.. 2021. “Dietary Fibre to Reduce Colon Cancer Risk in Alaska Native People: The Alaska FIRST Randomised Clinical Trial Protocol”. BMJ Open. BMJ. doi:10.1136/bmjopen-2020-047162.
- O'Keefe SJ. Diet, microorganisms and their metabolites, and colon cancer. Nat Rev Gastroenterol Hepatol. 2016 Dec;13(12):691-706. doi: 10.1038/nrgastro.2016.165. Epub 2016 Nov 16.
- Stephen O'Keefe 2017. "Fiber to Reduce Colon Cancer in Alaska Native People". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03028831.
Frequently Asked Questions
Is the target demographic of this trial exceeding 25 years?
"The minimum age of admission for this particular medical study is 40 years old, with the maximum set at 70." - Anonymous Online Contributor
Are there any vacancies in this clinical trial for participants?
"The clinical trial is currently recruiting and was published on December 11th, 2017; the information posted online has been recently updated as of February 8th 2021." - Anonymous Online Contributor
How many participants are currently being evaluated in this clinical experiment?
"Affirmative. Upon inspection of the information provided on clinicaltrials.gov, it is evident that this medical trial began recruitment in December 2017 and was recently updated in February 2022. The study requires 60 participants between two appointed sites." - Anonymous Online Contributor
May I partake in this clinical investigation?
"This clinical trial is recruiting 60 colon cancer patients aged between 40 and 70. To be accepted, applicants must be in a healthy gastrointestinal state with body mass index ranging from 18-40 Kg/m2. Previous studies have found no difference in responses to fibre diets amongst those of various weights including the overweight or obese. Those who had noncancerous polyps removed previously are also eligible for this trial, as well as Alaska Native individuals enrolled in their Tribal Health System program." - Anonymous Online Contributor