Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer trial study protocol: a randomised clinical trial of fibre-rich legumes targeting the gut microbiome, metabolome and gut transit time of overweight and obese patients with a history of noncancerous adenomatous polyps.
Study Goal
The researchers aimed to test whether a high-fibre diet featuring legumes (beans) could simultaneously facilitate weight reduction and suppress colonic mucosal biomarkers of colorectal cancer in overweight/obese adults with a history of colorectal polyps.
Results Summary
The abstract describes the study design but does not report results, as the study is ongoing.
Population
Overweight or obese adults with a history of noncancerous adenomatous polyps within the previous 3 years.
Effective Dosage
Preportioned high-fibre legume-rich entrées for two meals/day in months 1-3 and one meal/day in months 4-6.
Duration
6 months
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
fibre-rich legumes, such as cooked dry beans | increase | metabolic health | - | - | support the beneficial effects | #1 |
fibre-rich legumes, such as cooked dry beans | decrease | cancer risk | - | - | support the beneficial effects | #2 |
high-fibre diet featuring legumes | decrease | weight reduction | participants with overweight/obesity and a history of colorectal polyps | - | will test whether... will simultaneously facilitate | #3 |
high-fibre diet featuring legumes | decrease | colonic mucosal biomarkers of colorectal cancer (CRC) | participants with overweight/obesity and a history of colorectal polyps | - | will test whether... will suppress | #4 |
high-fibre legume-rich entrées | decrease | body weight | overweight or obese adults with a history of noncancerous adenomatous polyps | - | designed to characterise changes in | #5 |
high-fibre legume-rich entrées | decrease | biomarkers of insulin resistance | overweight or obese adults with a history of noncancerous adenomatous polyps | - | designed to characterise changes in | #6 |
high-fibre legume-rich entrées | decrease | biomarkers of systemic inflammation | overweight or obese adults with a history of noncancerous adenomatous polyps | - | designed to characterise changes in | #7 |
high-fibre legume-rich entrées | increase | compositional and functional profiles of the faecal microbiome | overweight or obese adults with a history of noncancerous adenomatous polyps | - | designed to characterise changes in | #8 |
high-fibre legume-rich entrées | increase | compositional and functional profiles of the metabolome | overweight or obese adults with a history of noncancerous adenomatous polyps | - | designed to characterise changes in | #9 |
high-fibre legume-rich entrées | decrease | mucosal biomarkers of CRC risk | overweight or obese adults with a history of noncancerous adenomatous polyps | - | designed to characterise changes in | #10 |
high-fibre legume-rich entrées | increase | gut transit | overweight or obese adults with a history of noncancerous adenomatous polyps | - | designed to characterise changes in | #11 |
INTRODUCTION: Recently published studies support the beneficial effects of consuming fibre-rich legumes, such as cooked dry beans, to improve metabolic health and reduce cancer risk. In participants with overweight/obesity and a history of colorectal polyps, the Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer randomised clinical trial will test whether a high-fibre diet featuring legumes will simultaneously facilitate weight reduction and suppress colonic mucosal biomarkers of colorectal cancer (CRC). METHODS/DESIGN: This study is designed to characterise changes in (1) body weight; (2) biomarkers of insulin resistance and systemic inflammation; (3) compositional and functional profiles of the faecal microbiome and metabolome; (4) mucosal biomarkers of CRC risk and (5) gut transit. Approximately 60 overweight or obese adults with a history of noncancerous adenomatous polyps within the previous 3 years will be recruited and randomised to one of two weight-loss diets. Following a 1-week run-in, participants in the intervention arm will receive preportioned high-fibre legume-rich entrées for two meals/day in months 1-3 and one meal/day in months 4-6. In the control arm, entrées will replace legumes with lean protein sources (eg, chicken). Both groups will receive in-person and written guidance to include nutritionally balanced sides with energy intake to lose 1-2 pounds per week. ETHICS AND DISSEMINATION: The National Institutes of Health fund this ongoing 5-year study through a National Cancer Institute grant (5R01CA245063) awarded to Emory University with a subaward to the University of Pittsburgh. The study protocol was approved by the Emory Institutional Review Board (IRB approval number: 00000563). TRIAL REGISTRATION NUMBER: NCT04780477.