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NCT Number: NCT06032104

Feasibility and Colorectal Benefits of Pulses Supplementation

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.

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Key information

Conditions

Colorectal Polyp Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis

Sacramento, California, 95817, United States

Location status: Recruiting

Location contact

Husham Abbas

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusions:

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

Exclusions:

  • 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)

Treatment and study plan

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

  1. 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

  2. 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).

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Change from baseline in body composition

    Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

    Body fat and muscle percentage measured using bio impedance analysis (BIA). Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet

  2. Change from baseline in body mass index (BMI)

    Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

    BMI measured using standard techniques. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet

  3. Change from baseline in waist circumference

    Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

    Waist circumference measured using standard techniques. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet

  4. Reported change from baseline in fitness level

    Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

    Investigators will compare the mean change in Abadie Perceived Physical Fitness Scale between paired baseline- and post- bean smoothie intervention vs. usual care. Perceived Physical Fitness Scale score range is 12-60, normal mean score is 42.46

  5. Reported change from baseline in and exercise per week

    Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy

    Investigators will use the modified Leisure-Time Exercise Questionnaire to compare the mean change in average weekly exercise (minutes of exercise per week) between paired baseline- and post- bean smoothie intervention vs. usual care

Study contacts

Contact information is provided by the study sponsor or research team.

Hisham Hussan, MD

CONTACT

[email protected]

(916) 734-8246

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Feasibility of Pulses Supplementation in Healthy Adults: A Feeding Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2023
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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