Feasibility and Colorectal Benefits of Pulses Supplementation

Study Overview
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Brief Summary
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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
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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 bean smoothie that the investigators will provide (Bush's Best Cannellini Beans) 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 the participant colonoscopy. Then, one month after colonoscopy, the participant will switch to the diet he was not assigned in the beginning for two weeks. Participants' involvement in this research will also include three brief research visits plus a research visit at the time of their scheduled standard-of-care colonoscopy (the research visit will be 30-60 minutes in length, scheduled at close to 2-4 weeks before colonoscopy, day of the colonoscopy, as well as 4-10 and 6-12 weeks after colonoscopy, depending on the 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 obtain some cells using a swab of the participant's 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.

Official Title
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Feasibility of Pulses Supplementation in Healthy Adults: A Feeding Study

Conditions
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Colorectal Polyp, Obesity

Intervention / Treatment
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* Dietary Supplement: Bush's Best Cannellini Beans
* Dietary Supplement: Usual diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 35-75 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 or suspected or confirmed inherited colorectal cancer 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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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-colonoscopy with a cross-over design to intervention vs. usual care after one month of washout post-colonoscopy. 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bean smoothie then usual diet<br>Participants first receive 2 weeks of adding bean smoothie to usual diet before colonoscopy. After a washout period of 4 weeks after colonoscopy, they receive usual diet for 2 weeks | Dietary Supplement: Bush's Best Cannellini Beans<br>* 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.<br>Dietary Supplement: Usual diet<br>* Usual diet without adding the bean smoothie<br>|
| Experimental: Usual diet then bean smoothie<br>Participants first receive 2 weeks of usual diet before colonoscopy. After a washout period of 4 weeks after colonoscopy, they then add bean smoothie to usual diet for 2 weeks | Dietary Supplement: Bush's Best Cannellini Beans<br>* 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.<br>Dietary Supplement: Usual diet<br>* Usual diet without adding the bean smoothie<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 6-12 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 6-12 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 6-12 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 6-12 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 6-12 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2-4 weeks prior to colonoscopy, till 6-12 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 | 2-4 weeks prior to colonoscopy, till 6-12 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 | 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy | 
| Change from baseline in median liver fat and stiffness values | Using FibroScan. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet | 2-4 weeks prior to colonoscopy, till 6-12 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 | 2-4 weeks prior to colonoscopy, till 6-12 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 | 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy |