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Active Not Recruiting
NCT04780477
Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer
Conditions: Colon Cancer, Obesity
Sex: All
Ages: 40 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Emory University
Location: Rollins School of Public Health, Emory University Atlanta Georgia
Summary
This study tests whether a high-fiber diet based on legumes, such as dry beans, can lead to sustained reductions in obesity and colon cancer risk in persons at highest risk, namely overweight or obese, post-polypectomy patients.
Eligibility Criteria
Inclusion Criteria:
* free-living adults 40 to 75 years old
* BMI 25-40 kg/m\^2
* able to provide documentation confirming a colonoscopy within 3 years that found ≥1 adenoma \>0.5 cm or a sessile serrated polyp (any)
* English speaking
* ambulatory, able to pick up food, participate in clinical exams and laboratory tests
* able to provide informed consent
Exclusion Criteria:
* serious and/or unstable medical condition as deemed by study physician
* history of colorectal cancer, bowel resection, polyposis syndrome, or inflammatory bowel disease
* smoked regularly in the past year
* dietary restrictions substantially limiting compliance (e.g., must be willing to be randomized to either diet)
* planning on substantially changing usual exercise behavior in the next 6 months
* regular or recent use of prescription medication that may alter inflammation markers or gut function as deemed by study physician
* pregnant women, breast feeding women, or women planning pregnancy within the year of active study participation
Source: ClinicalTrials.gov (NCT04780477). StuddyBuddy aggregates publicly available trial information.