NCT06032104 · University of California, Davis
Feasibility and Colorectal Benefits of Pulses Supplementation
What this study is about
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.
View original scientific description
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.
Interventions
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
Primary outcome measures
Compliance with the bean smoothie intervention
Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Mean percentage completion of bean smoothie intervention and mean percentage with positive breath test over 2 weeks
Tolerance to the bean smoothie intervention
Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Compare the mean change in individual gastrointestinal symptoms and scores between paired baseline- and post- bean smoothie intervention vs. usual care. Patient-Reported Outcomes Measurement Information System (PROMIS) survey T sore range is 1-100, normal average T score is 50 (Standard deviation of 10).
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
Compare the percent with abnormal complete metabolic panel or complete blood count between paired baseline- and post- bean smoothie intervention vs. usual care
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
Fecal microbiome assessment using 16s/metagenomics assay. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
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
Fecal and serum metabolomic assessment using an untargeted metabolomics assay. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
Impact of bean intervention on colonic tissue RNA markers of health
Time frame: 2-4 weeks prior to colonoscopy till colonoscopy
Compare colonic tissue RNA-seq assay between participants randomized to bean intervention vs usual care before the colonoscopy
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 30-80 years-old
- Overweight or obesity (body mass index ≥ 25 kg/m2)
- Planned for a standard of care colonoscopy for colon cancer screening
Exclusion criteria
- Intolerance to a bean or high bean consumer based on a screening survey
- Pregnancy or actively planning to get pregnant
- Any active gastrointestinal disease resulting in disturbed gut function or malabsorption (e.g., chronic diarrhea or inflammatory bowel disease)
- Current or history of any malignancy in the past 10 years.
- Chronic use of opioids, anti-inflammatory drugs, antibiotics, prebiotics, or probiotics within 1 month of study endpoints
- 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)
Where
- Sacramento, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2025 · Source of record for eligibility and locations