Feasibility and Colorectal Benefits of Pulses Supplementation

Sponsor

University of California, Davis (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06032104

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Polyp Obesity	Dietary Supplement: Bush's Best Cannellini Beans Dietary Supplement: Usual diet	Phase 1

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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 (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Feasibility of Pulses Supplementation in Healthy Adults: A Feeding Study

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bean smoothie then usual diet 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 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. Dietary Supplement: Usual diet Usual diet without adding the bean smoothie
Experimental: Usual diet then bean smoothie 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 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. Dietary Supplement: Usual diet Usual diet without adding the bean smoothie

Arm

Intervention/Treatment

Experimental: Bean smoothie then usual diet

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

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.

Dietary Supplement: Usual diet

Usual diet without adding the bean smoothie

Experimental: Usual diet then bean smoothie

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

Dietary Supplement: Usual diet

Usual diet without adding the bean smoothie

Outcome Measures

Primary Outcome Measures

Compliance with the bean smoothie intervention [2-4 weeks prior to colonoscopy, till 6-12 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 [2-4 weeks prior to colonoscopy, till 6-12 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 [2-4 weeks prior to colonoscopy, till 6-12 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 [2-4 weeks prior to colonoscopy, till 6-12 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 [2-4 weeks prior to colonoscopy, till 6-12 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 [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 Outcome Measures

Change from baseline in body composition [2-4 weeks prior to colonoscopy, till 6-12 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
Change from baseline in body mass index (BMI) [2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy]
BMI measured using standard techniques. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
Change from baseline in waist circumference [2-4 weeks prior to colonoscopy, till 6-12 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
Change from baseline in median liver fat and stiffness values [2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy]
Using FibroScan. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
Reported change from baseline in fitness level [2-4 weeks prior to colonoscopy, till 6-12 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
Reported change from baseline in and exercise per week [2-4 weeks prior to colonoscopy, till 6-12 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator: Hisham Hussan, MD, UC Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, Davis

ClinicalTrials.gov Identifier:

NCT06032104

Other Study ID Numbers:

2012455

First Posted:

Sep 11, 2023

Last Update Posted:

Sep 15, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 15, 2023