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
Jia V Li,
Barbara Methe,
Terryl J Hartman,
Thomas R Ziegler,
Annette Wilson,
Stephen J D O'Keefe,
Jennifer Christie,
William Dana Flanders,
Barbara J Rolls,
Blaine Loye Eberhart,
Helaina Huneault,
Ben Cousineau,
Miriam R Perez
Affiliations
Jia V Li
9 Section of Nutrition Research, Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Commonwealth Building, Hammersmith Hospital Campus, Imperial College London, South Kensington, London, UK
Barbara Methe
6 Pulmonary, Allergy and Critical Care Medicine, Center for the Microbiome and Medicine, University of Pittsburg, Pittsburgh, Pennsylvania, USA
Terryl J Hartman
1 Department of Epidemiology, Rollins School of Public Health and Winship Cancer Institute, Emory University, Atlanta, Georgia, USA
Thomas R Ziegler
5 Department of Medicine, Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, Georgia, USA
Annette Wilson
4 Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
Stephen J D O'Keefe
4 Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
Jennifer Christie
3 Department of Medicine, Division of Digestive Diseases, Emory University School of Medicine, Atlanta, Georgia, USA
William Dana Flanders
7 Department of Biostatistics and Bioinformatics, Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA
Barbara J Rolls
8 Department of Nutritional Sciences, The Pennsylvania State University, State College, Pennsylvania, USA
Blaine Loye Eberhart
4 Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
Helaina Huneault
2 Nutrition and Health Sciences, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA
Ben Cousineau
2 Nutrition and Health Sciences, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA
Miriam R Perez
4 Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
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.
