Feasibility and Colorectal Benefits of Pulses Supplementation

Obesity Clinical Trial

Official title:

Feasibility of Pulses Supplementation in Healthy Adults: A Feeding Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032104
• Other study ID #: 2012455
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2023
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: University of California, Davis
• Contact: Hisham Hussan, MD
• Phone: (916) 734-8246
• Email: hhussan[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators also hope that this research study will help us understand ways to improve human diet and prevent colon cancer in the future.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Polyp
• Obesity

Intervention

Dietary Supplement:
• Dry 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. 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
Usual diet without adding the bean smoothie

Locations

Country	Name	City	State
United States	University of California Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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 2-12 weeks after colonoscopy
Secondary	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 2-12 weeks after colonoscopy
Secondary	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 2-12 weeks after colonoscopy
Secondary	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 2-12 weeks after colonoscopy
Secondary	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 2-12 weeks after colonoscopy