Colon Cancer Clinical Trial
Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer
Summary
The study will target a population at high risk for colorectal cancer, overweight and obese participants with a history of a colon polyp in the past 3 years to test whether a high-legume, high-fiber diet will simultaneously increase weight loss and suppress intestinal biomarkers of cancer risk compared to a control diet (healthy American). In addition, it will explore potential mechanisms through which the high-legume intervention diet facilitates weight loss and intestinal health.
Full Description
The goal of the research is to conduct a clinical trial featuring study-provided pre-portioned entrées (2 entrées per day months 1-3, 1 entrée per day months 4-6) and strategic nutritional instruction to guide participants to integrate legumes into a healthy high-fiber diet pattern. The research will target a population at high risk for colorectal cancer, overweight and obese participants with a history of a colon polyp in the past 3 years, to test whether a high-legume, high-fiber diet will simultaneously increase weight loss and suppress intestinal biomarkers of cancer risk compared to a control diet (healthy American). In addition, it will explore potential mechanisms through which the high-legume intervention diet facilitates weight loss and intestinal health.
Eligibility Criteria
Inclusion Criteria:
free-living adults 40-75 yrs. old
BMI 25-40 kg/m2
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
Exclusion Criteria:
serious medical condition (e.g., cancer, heart disease, kidney disease, diabetes,)
history of CRC, 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 mos
regular use of medication that may alter inflammation markers, insulin, glucose, or gut function (e.g., non-steroidal anti-inflammatory drugs, antibiotics, insulin, steroids)
pregnant women, breast feeding women, or women planning pregnancy within the year of active study participation
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