Clinical trial

Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04780477

Active, not recruitingNot applicableInterventional

What this study is about

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, post-polypectomy patients.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionColon Cancer, Obesity

Full registry criteria

Inclusion Criteria: * 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 Criteria: * 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

Treatments and study arms

High Fiber Diet Featuring Legumes (HLD)

Dietary Supplement

The high fiber diet featuring legumes (HLD) provides pre-portioned entrées for two meals per day in months 1-3, and one meal per day in months 4-6. Participants continue on the diet in months 7-12 but assume responsibility for food preparation. The HLD will contain approximately 250 grams (g) of legumes per day (\~1 ½ cups cooked legumes) in months 1-3 provided in two pre-portioned single serving entrées (i.e. \~125g in each serving). A study nutritionist provides in-person and written guidance for including side dishes that are nutritionally balanced with energy intake to lose 1-2 pounds of weight per week.

Healthy American Diet

Dietary Supplement

The healthy American diet provides pre-portioned meal replacement entrées with legumes replaced by lean chicken or meat. Participants continue on the diet in months 7-12 but assume responsibility for food preparation. A study nutritionist provides in-person and written guidance for including side dishes that are nutritionally balanced with energy intake to lose 1-2 pounds of weight per week.

Primary outcomes

Change in Body WeightBaseline, Month 6 (end of intense intervention)

Body weight is measured (in pounds) on a regularly calibrated digital scale while wearing light clothing without shoes.

Change in Ki-67+ LevelBaseline, Month 6 (end of intense intervention)

Mucosal biopsies are obtained to measure the colonic mucosal proliferative biomarker Ki-67+.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Rollins School of Public Health, Emory University🇺🇸 Atlanta, Georgia, United States

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