Feasibility and Colorectal Benefits of Pulses Supplementation

University of California (UC) Davis

Status: Enrolling

Conditions: Colorectal Polyp; Obesity

Treatments: Dietary Supplement: Usual diet; Dietary Supplement: Dry beans

Study type: Interventional

Funder types: Other

Identifiers

NCT06032104

2012455

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Bean smoothie then usual diet

Experimental group

Description:

Participants first receive 2 weeks of adding bean smoothie to usual diet before colonoscopy. After colonoscopy, they receive usual diet for 2 weeks

Treatment:

Dietary Supplement: Dry beans

Dietary Supplement: Usual diet

Usual diet then bean smoothie

Experimental group

Description:

Participants first receive 2 weeks of usual diet before colonoscopy. After colonoscopy, they add bean smoothie to usual diet for 2 weeks

Treatment:

Dietary Supplement: Dry beans

Dietary Supplement: Usual diet