Feasibility and Colorectal Benefits of Pulses Supplementation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorUniversity of California, Davis
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
30-80 years-old
Overweight or obesity (body mass index ≥ 25 kg/m2)
Planned for a standard of care colonoscopy for colon cancer screening
Intolerance to a bean or high bean consumer based on a screening survey
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Dry beans
Dietary supplement0.5 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 supplementUsual diet without adding the bean smoothie
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Bean smoothie then usual dietExperimental treatment 2 interventions
Group B: Usual diet then bean smoothieExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Compliance with the bean smoothie intervention
Mean percentage completion of bean smoothie intervention and mean percentage with positive breath test over 2 weeks
Time frame
2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy2
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).
Time frame
2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy3
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
Time frame
2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy4
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
Time frame
2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopySecondary outcomes
1
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
Time frame
2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy2
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
Time frame
2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy3
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
Time frame
2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy4
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
Time frame
2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov