This phase II trial investigates whether a high-fiber diet featuring legumes can reduce obesity and colon cancer risk in middle-aged overweight and obese participants that may have undergone removal of a polyp (polypectomy). A natural high-fiber diet based on legumes may lead to greater weight loss and improvements in biomarkers associated with colon cancer risk compared to a control diet.
Additional locations may be listed on ClinicalTrials.gov for NCT04780477.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer InstituteStatus: Active
Contact: Terry Hartman
Phone: 404-727-8713
PRIMARY OBJECTIVE:
I. To test whether a high-fiber diet based on legumes, such as dry beans, can lead to sustained reductions in obesity and colon cancer risk in those at highest risk, namely overweight / obese post-polypectomy patients.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (HIGH-FIBER DIET): Participants receive a high-fiber diet consisting of pre-portioned single-serving entree meals with legumes twice daily (BID) for months 1-3, and once daily (QD) for months 4-6. Participants continue on their respective diets for months 7-12. Participants are contacted by the study coordinator regularly during the first 1-2 weeks to answer their questions, provide support, and encourage adherence.
GROUP II (CONTROL DIET): Participants receive a healthy American diet consisting of pre-portioned single-serving meal replacement entrees with lean chicken/meat BID for months 1-3, and QD for months 4-6. Participants continue on their respective diets for months 7-12. Participants are contacted by the study coordinator regularly during the first 1-2 weeks to answer their questions, provide support, and encourage adherence.
After completion of study, participants are followed up for 1 year, and then until the next routine surveillance colonoscopy for those who have a colonoscopy.
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorTerry Hartman