Feasibility and Colorectal Benefits of Pulses Supplementation

NCT06032104 | Recruiting DMC

• 1 other identifier: 2012455
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Compliance with the bean smoothie intervention

  Mean percentage completion of bean smoothie intervention and mean percentage with positive breath test over 2 weeks

  2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

• Tolerance to the bean smoothie intervention

  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).

  2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

• Effect of the bean smoothie intervention on serum biomarkers of health

  Compare the percent with abnormal complete metabolic panel or complete blood count between paired baseline- and post- bean smoothie intervention vs. usual care

  2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

• Change in fecal abundance of microbiome genes with bean smoothie intervention

  Fecal microbiome assessment using 16s/metagenomics assay. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet

  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

  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

  2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

• Impact of bean intervention on colonic tissue RNA markers of health

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

  2-4 weeks prior to colonoscopy till colonoscopy

Secondary Outcomes (5)

• Change from baseline in body composition

  2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

• Change from baseline in body mass index (BMI)

  2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

• Change from baseline in waist circumference

  2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

• Reported change from baseline in fitness level

  2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

• Reported change from baseline in and exercise per week

  2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

Study Arms (2)

Bean smoothie then usual diet

EXPERIMENTAL

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

Dietary Supplement: Dry beans; Dietary Supplement: Usual diet

Usual diet then bean smoothie

EXPERIMENTAL

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

Dietary Supplement: Dry beans; Dietary Supplement: Usual diet

Interventions

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)

Bean smoothie then usual diet; Usual diet then bean smoothie

Usual diet DIETARY_SUPPLEMENT

Usual diet without adding the bean smoothie

Bean smoothie then usual diet; Usual diet then bean smoothie

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hisham Hussan, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hisham Hussan, MD

CONTACT

(916) 734-8246; hhussan@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The randomized clinical trial has a cross-over design. The 20 participants will be randomized to a 14-day bean intervention versus usual care pre- or post-colonoscopy with a cross-over design. The 14-day bean intervention will be preceded by a 3-day ramp-up, acclimation, phase of beans feeding starting at one 1/2 cup of beans for day 1, followed by two 1/2 cups/day for days 2 and 3, then the full dose of three 1/2 cups/day for 14 days afterwards. Participants will be randomized 1:1 using a stratified randomization design. The randomization strata will be sex and presence/absence of metabolic syndrome factors with 1:1 ratio. Investigators anticipate a 20% dropout; therefore, investigators will recruit 25 participants to complete procedures on 20.

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 11, 2023
• Study Start: October 27, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)