Colorectal PolypNCT06032104
Feasibility and Colorectal Benefits of Pulses Supplementation
A study testing Dry beans and Usual diet in people with Colorectal Polyp and Obesity, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyp, Obesity
- What is being tested?
- Dry beans and Usual diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Sacramento, California, 95817
About this study
Official title: Feasibility of Pulses Supplementation in Healthy Adults: A Feeding Study
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.
Read the detailed description
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.
- Conditions
- Colorectal Polyp, Obesity
- Being tested
- Dry beans, Usual diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry beansDietary 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 dietDietary supplement
Usual diet without adding the bean smoothie
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Dry beans; Dietary Supplement: Usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with the bean smoothie intervention
Mean percentage completion of bean smoothie intervention and mean percentage with positive breath test over 2 weeks
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2-4 weeks prior to colonoscopy till colonoscopy
Secondary outcomes (5)
Change from baseline in body composition
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
Measured: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Change from baseline in body mass index (BMI)
BMI measured using standard techniques. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
Measured: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Change from baseline in waist circumference
Waist circumference measured using standard techniques. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
Measured: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Reported change from baseline in fitness level
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
Measured: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Reported change from baseline in and exercise per week
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
Measured: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start27 Oct 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hisham Hussan, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032104
- Sponsor's protocol ID
- 2012455
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Pulses Supplementation in Healthy Adults: A Feeding Study
- ClinicalTrials.gov ID
- NCT06032104
- Acronym / sponsor ID
- 2012455
- Conditions
- Colorectal Polyp, Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bean smoothie then usual diet | Experimental | Dietary Supplement: Dry beans, Dietary Supplement: Usual dietParticipants first receive 2 weeks of adding bean smoothie to usual diet before colonoscopy. After colonoscopy, they receive usual diet for 2 weeks |
| Usual diet then bean smoothie | Experimental | Dietary Supplement: Dry beans, Dietary Supplement: Usual dietParticipants first receive 2 weeks of usual diet before colonoscopy. After colonoscopy, they add bean smoothie to usual diet for 2 weeks |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry beans0.5 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 | Bean smoothie then usual diet, Usual diet then bean smoothie |
| Usual dietUsual diet without adding the bean smoothie | Dietary supplement | Bean smoothie then usual diet, Usual diet then bean smoothie |
Primary outcome
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
5 secondary outcomes
Change from baseline in body composition
Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Change from baseline in body mass index (BMI)
Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Change from baseline in waist circumference
Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Reported change from baseline in fitness level
Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Reported change from baseline in and exercise per week
Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hisham Hussan, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry beans and Usual diet in people with Colorectal Polyp and Obesity, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with the bean smoothie intervention (time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.