Fiber-Rich Foods for the Treatment of Obesity and Prevention of Colon Cancer
40 - 75 Years, Male and Female
RSPH5056-20 (primary)
NCI-2020-04372
Summary
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.
Objectives
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.
Eligibility
- Free-living adults 40-75 years (yrs.) old
- Body mass index (BMI) 25-40 kg/m^2
- Colonoscopy within 3 years that found >= 1 adenoma >= 0.5 cm
- English speaking
- Ambulatory, able to pick up food, participate in clinical exams and laboratory tests
- Able to provide informed consent
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