Feasibility and Colorectal Benefits of Pulses Supplementation
- Conditions
- ObesityColorectal Polyp
- Interventions
- Dietary Supplement: Dry beansDietary Supplement: Usual diet
- Registration Number
- NCT06032104
- Lead Sponsor
- University of California, Davis
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Usual diet then bean smoothie Usual diet Participants first receive 2 weeks of usual diet before colonoscopy. After colonoscopy, they add bean smoothie to usual diet for 2 weeks Bean smoothie then usual diet Usual diet Participants first receive 2 weeks of adding bean smoothie to usual diet before colonoscopy. After colonoscopy, they receive usual diet for 2 weeks Bean smoothie then usual diet Dry beans Participants 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 Dry beans Participants first receive 2 weeks of usual diet before colonoscopy. After colonoscopy, they add bean smoothie to usual diet for 2 weeks
- Primary Outcome Measures
Name Time Method Change from baseline in the fecal and serum metabolome with bean smoothie intervention 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
Compliance with the bean smoothie intervention 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
Effect of the bean smoothie intervention on serum biomarkers of health 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
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
Tolerance to the bean smoothie intervention 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).
Change in fecal abundance of microbiome genes with bean smoothie intervention 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
- Secondary Outcome Measures
Name Time Method Change from baseline in body mass index (BMI) 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy BMI measured using standard techniques. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
Reported change from baseline in fitness level 2-4 weeks prior to colonoscopy, till 2-12 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 2-12 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
Change from baseline in waist circumference 2-4 weeks prior to colonoscopy, till 2-12 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 body composition 2-4 weeks prior to colonoscopy, till 2-12 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
Trial Locations
- Locations (1)
University of California Davis
🇺🇸Sacramento, California, United States