Fiber-Rich Foods for the Treatment of Obesity and Prevention of Colon Cancer

Active:	Yes
Cancer Type:	Colon/Rectal Cancer	NCT ID:	NCT04780477
Trial Phases:	Phase II	Protocol IDs:	RSPH5056-20 (primary) NCI-2020-04372
Eligibility:	40 - 75 Years, Male and Female	Study Type:	Prevention
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04780477

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.