Recruiting

Pulses

Sponsor:

UCLA

Code:

NCT06032104

Conditions

Colorectal Polyp

Obesity

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

Dry beans

Usual diet

Study Details

Brief 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.

Conditions

Colorectal Polyp

Obesity

Study ID

NCT06032104

Start date

Oct 27, 2023

Status verified date

Dec, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Inclusions:

1. 30-80 years-old
2. Overweight or obesity (body mass index ≥ 25 kg/m2)
3. Planned for a standard of care colonoscopy for colon cancer screening

Exclusions:

1. Intolerance to a bean or high bean consumer based on a screening survey
2. Pregnancy or actively planning to get pregnant
3. Any active gastrointestinal disease resulting in disturbed gut function or malabsorption (e.g., chronic diarrhea or inflammatory bowel disease)
4. Current or history of any malignancy in the past 10 years.
5. Chronic use of opioids, anti-inflammatory drugs, antibiotics, prebiotics, or probiotics within 1 month of study endpoints
6. History of a significant systemic condition (e.g., heart disease, chronic kidney disease, liver dysfunction or immune suppression), or abnormal laboratory markers (e.g., abnormal liver enzymes, creatinine, clotting factors, or low platelets count). The severity of the intolerance to fiber/ the medical conditions/lab markers and eligibility will be defined after the careful interview of the patient/review of the medical records by Dr. Hussan)

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Bean smoothie then usual diet

Participants first receive 2 weeks of adding bean smoothie to usual diet before colonoscopy. After colonoscopy, they receive usual diet for 2 weeks

experimental: Usual diet then bean smoothie

Participants first receive 2 weeks of usual diet before colonoscopy. After colonoscopy, they add bean smoothie to usual diet for 2 weeks

Interventions

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)

Usual diet

Usual diet without adding the bean smoothie

Primary outcome measure

  • Compliance with the bean smoothie intervention [ Time Frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy ]
  • Tolerance to the bean smoothie intervention [ Time Frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy ]
  • Effect of the bean smoothie intervention on serum biomarkers of health [ Time Frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy ]
  • Change in fecal abundance of microbiome genes with bean smoothie intervention [ Time Frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy ]
  • Change from baseline in the fecal and serum metabolome with bean smoothie intervention [ Time Frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy ]
  • Impact of bean intervention on colonic tissue RNA markers of health [ Time Frame: 2-4 weeks prior to colonoscopy till colonoscopy ]

Central Contacts and Locations

Central contacts

Hisham Hussan, MD

(916) 734-8246hhussan@ucdavis.edu

Locations

University of California Davis

Recruiting

Sacramento, California, United States, 95817

More Information

Sponsor

University of California, Davis

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2025-12-05.