Journal article
Dietary fibre to reduce colon cancer risk in Alaska Native people: the Alaska FIRST randomised clinical trial protocol
BMJ Open, Vol.11(8), Art. e047162
2021
Abstract
Introduction Diet, shown to impact colorectal cancer (CRC) risk, is a modifiable environmental factor. Fibre foods fermented by gut microbiota produce metabolites that not only provide food for the colonic epithelium but also exert regulatory effects on colonic mucosal inflammation and proliferation. We describe methods used in a double-blinded, randomised, controlled trial with Alaska Native (AN) people to determine if dietary fibre supplementation can substantially reduce CRC risk among people with the highest reported CRC incidence worldwide.
Methods and analyses Eligible patients undergoing routine screening colonoscopy consent to baseline assessments and specimen/data collection (blood, urine, stool, saliva, breath and colon mucosal biopsies) at the time of colonoscopy. Following an 8-week stabilisation period to re-establish normal gut microbiota post colonoscopy, study personnel randomise participants to either a high fibre supplement (resistant starch, n=30) or placebo (digestible starch, n=30) condition, repeating stool sample collection. During the 28-day supplement trial, each participant consumes their usual diet plus their supplement under direct observation. On day 29, participants undergo a flexible sigmoidoscopy to obtain mucosal biopsy samples to measure the effect of the supplement on inflammatory and proliferative biomarkers of cancer risk, with follow-up assessments and data/specimen collection similar to baseline. Secondary outcome measures include the impact of a high fibre supplement on the oral and colonic microbiome and biofluid metabolome.
Ethics and dissemination Approvals were obtained from the Alaska Area and University of Pittsburgh Institutional Review Boards and Alaska Native Tribal Health Consortium and Southcentral Foundation research review bodies. A data safety monitoring board, material transfer agreements and weekly study team meetings provide regular oversight throughout the study. Study findings will first be shared with AN tribal leaders, health administrators, providers and community members. Peer-reviewed journal articles and conference presentations will be forthcoming once approved by tribal review bodies.
Details
- Title
- Dietary fibre to reduce colon cancer risk in Alaska Native people: the Alaska FIRST randomised clinical trial protocol
- Authors/Creators
- K.R. Koller (Author/Creator) - Alaska Native Tribal Health ConsortiumA. Wilson (Author/Creator) - University of PittsburghD.P. Normolle (Author/Creator) - University of PittsburghJ.K. Nicholson (Author/Creator) - Murdoch UniversityJ.V. Li (Author/Creator) - Imperial College LondonJ. Kinross (Author/Creator) - Imperial College LondonF.R. Lee (Author/Creator) - Alaska Native Tribal Health ConsortiumC.A. Flanagan (Author/Creator) - Alaska Native Tribal Health ConsortiumZ.T. Merculieff (Author/Creator) - Alaska Native Tribal Health ConsortiumP. Iyer (Author/Creator) - University of PittsburghD.L. Lammers (Author/Creator) - Alaska Native Tribal Health ConsortiumT.K. Thomas (Author/Creator)S.J.D. O'Keefe (Author/Creator) - University of Pittsburgh
- Publication Details
- BMJ Open, Vol.11(8), Art. e047162
- Publisher
- BMJ Publishing Group
- Identifiers
- 991005542208007891
- Copyright
- © 2021 The Authors.
- Murdoch Affiliation
- Australian National Phenome Centre
- Language
- English
- Resource Type
- Journal article
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- Collaboration types
- Domestic collaboration
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- Citation topics
- 1 Clinical & Life Sciences
- 1.120 Inflammatory Bowel Diseases & Infections
- 1.120.384 Gut Microbiota
- Web Of Science research areas
- Nutrition & Dietetics
- ESI research areas
- Clinical Medicine