Feasibility and Colorectal Benefits of Pulses Supplementation

Official title

Feasibility of Pulses Supplementation in Healthy Adults: A Feeding Study

Overview

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.

Interventions

• 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
• Dietary supplement Usual diet
  Usual diet without adding the bean smoothie

Primary outcome measures

• Compliance with the bean smoothie intervention [Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Tolerance to the bean smoothie intervention [Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Effect of the bean smoothie intervention on serum biomarkers of health [Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Change in fecal abundance of microbiome genes with bean smoothie intervention [Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Change from baseline in the fecal and serum metabolome with bean smoothie intervention [Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Impact of bean intervention on colonic tissue RNA markers of health [Time frame: 2-4 weeks prior to colonoscopy till colonoscopy]

Secondary outcome measures (5)

• Change from baseline in body composition [Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Change from baseline in body mass index (BMI) [Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Change from baseline in waist circumference [Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Reported change from baseline in fitness level [Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]
• Reported change from baseline in and exercise per week [Time frame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy]

Eligibility criteria

Inclusions:

• 30-80 years-old
• Overweight or obesity (body mass index ≥ 25 kg/m2)
• Planned for a standard of care colonoscopy for colon cancer screening

Exclusions:

• 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 in the past 10 years.
• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Other

Study locations

United States · 1 center

• University of California Davis — Sacramento

Identifiers

NCT: NCT06032104 · 2012455

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗