Status:
ACTIVE_NOT_RECRUITING
Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colon Cancer
Obesity
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief 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...
Detailed Description
An important knowledge gap concerns the role of fiber in sustaining reduced energy intake to simultaneously manage weight and influence human colorectal cancer risk. Epidemiologic studies have shown a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04780477
Start Date
June 29 2021
End Date
December 1 2025
Last Update
July 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rollins School of Public Health, Emory University
Atlanta, Georgia, United States, 30322