This randomized pilot trial studies how well beans work in improving the gut microbiome and blood biomarkers in overweight and obese colorectal adenoma patients and cancer survivors. Eating canned, pre-cooked beans may help improve the levels of healthy bacteria in the digestive system and reduce the effects of obesity on cancer risk in patients with or without a previous history of colorectal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02843425.
PRIMARY OBJECTIVES:
I. To examine the effect of increased consumption of dry beans on the gut microbiome and blood biomarkers of overweight and obese individuals otherwise consuming their usual diet.
Ia. To examine the effect of increased consumption of dry beans on the diversity and composition of the gut microbiome.
Ib. To examine the relationship between changes in the gut microbiome and changes in host biomarkers, including established fecal surrogates of gut inflammation and integrity, circulating adipocytokines, and a comprehensive blood lipid and metabolic panel.
SECONDARY OBJECTIVES:
I. To pilot the field and research procedures of a prospective randomized crossover dietary intervention of dry beans, including compliance in our target population and the modifying effects of the baseline gut microbiome and usual diet on individual’s response to the intervention.
OUTLINE: Participants are randomized to 1 of 2 groups.
Group I (Intervention Diet): Participants add 1/2 cup of canned beans per day to their diet for 2 weeks, and then 1 cup per day for 6 weeks. After completion of intervention diet, participants crossover into control diet for 8 weeks.
Group II (Control Diet): Participants will follow their normal diet (not including beans) for 8 weeks and then crossover to intervention diet for 8 weeks.
After the completion of study treatment, patients are followed up at 6 months and 1 year and twice a year for up to 5 years.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorCarrie Daniel-MacDougall
