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Dietary fibre to reduce colon cancer risk in Alaska Native people: the Alaska FIRST randomised clinical trial protocol
- Source :
- BMJ Open, BMJ Open, Vol 11, Iss 8 (2021)
- Publication Year :
- 2021
- Publisher :
- BMJ Journals, 2021.
-
Abstract
- IntroductionDiet, 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 analysesEligible 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 disseminationApprovals 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.Trial registration numberNCT03028831.
- Subjects :
- Dietary Fiber
medicine.medical_specialty
Colorectal cancer
Colonoscopy
gastroenterology
Gastroenterology and Hepatology
Gut flora
law.invention
1117 Public Health and Health Services
Randomized controlled trial
law
Internal medicine
medicine
Data monitoring committee
Humans
Randomized Controlled Trials as Topic
nutrition & dietetics
medicine.diagnostic_test
biology
business.industry
public health
Sigmoidoscopy
1103 Clinical Sciences
General Medicine
biology.organism_classification
medicine.disease
Alaskan Natives
Clinical trial
Specimen collection
Colonic Neoplasms
Medicine
business
bacteriology
Alaska
1199 Other Medical and Health Sciences
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- BMJ Open, BMJ Open, Vol 11, Iss 8 (2021)
- Accession number :
- edsair.doi.dedup.....ebb4327736114e5bac05547ed2e38591