Clinical trial

Feasibility and Colorectal Benefits of Pulses Supplementation

Recruiting now · Not applicable · 1 countries · Registry ID NCT06032104

Recruiting nowNot applicableInterventional

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. The investigators also hope that this research study will help us understand ways to improve human diet and prevent colon cancer in the future.

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

Age30 Years to 80 Years

SexAll

Healthy volunteersAccepted

ConditionColorectal Polyp, Obesity

Full registry criteria

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)

Treatments and study arms

Dry beans

Dietary Supplement

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

Dietary Supplement

Usual diet without adding the bean smoothie

Primary outcomes

Compliance with the bean smoothie intervention2-4 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 intervention2-4 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 health2-4 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 intervention2-4 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 intervention2-4 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 health2-4 weeks prior to colonoscopy till colonoscopy

Compare colonic tissue RNA-seq assay between participants randomized to bean intervention vs usual care before the colonoscopy

Study locations

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

University of California Davis🇺🇸 Sacramento, California, United States

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Husham AbbasContact