NCT06032104

Feasibility and Colorectal Benefits of Pulses Supplementation

Feasibility of Pulses Supplementation in Healthy Adults: A Feeding Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Beans are a forgotten staple food that shows promise in improving health. The goal of this study is to look at how bean supplementation affects metabolic and bowel health. In the long-term, the investigators believe this research will lead to a better understanding of the impact of beans on bowel health. The investigators also hope that this research study will help us understand ways to improve human diet and prevent colon cancer in the future.

Detailed description

Investigators are seeking adults planning for a standard of care colonoscopies (part of the participant's usual care). As part of this feeding study, a participant will be randomly assigned to either two weeks of a dry bean smoothie that the investigators will provide in addition to the participant's usual diet or continue with participant's usual diet without the bean smoothie (including the food and drink guidelines for the colonoscopy) 2 weeks before or after the participant colonoscopy. Participants' involvement in this research will also include 2 research visits plus a visit on the day of their scheduled standard-of-care colonoscopy (each research visit will be 30-60 minutes in length, scheduled close to 2-4 weeks prior to the colonoscopy, day of the colonoscopy, as well as 2-12 weeks after the colonoscopy, depending on participant availability. The investigators expect about 25 people aged 35-75 to participate in this research. Participation in this study will involve collecting breath tests, fecal (stool) samples, 8 Teaspoons of blood, clinical data, and participant questionnaire data. At the time of colonoscopy, the investigators will also sample the mucosa lining of the bowel and remnant (leftover or discarded) tissue from an intestine biopsy obtained as part of the participant's clinical care. Participants will be asked to sign a separate HIPAA authorization form to allow the investigators to collect information from participant's medical records. This information will become part of the research data.

Conditions

• Colorectal Polyp
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dry beans	0.5 cup of Bush's Best Cannellini Beans, three times per day before meals blended into a smoothie. If interested and depending on tolerance, participants will also have the opportunity to gradually increase the bean smoothie to a maximum of 1 cup three times per day before meals during the last week of the two-week bean smoothie intervention. If patient cannot not tolerate 1.5 cup of canned cannellini bean, we will reduce per tolerance or offer the option of choosing a bean-based flour (100 gram/day, 23% fiber from Archer Daniels Midland)
DIETARY_SUPPLEMENT	Usual diet	Usual diet without adding the bean smoothie

Timeline

• Start date: 2023-10-27
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2023-09-11
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States