Clinical trial NCT06032104: Feasibility and Colorectal Benefits of Pulses Supplementation
Official title: Feasibility of Pulses Supplementation in Healthy Adults: A Feeding Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Polyp
Obesity
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The randomized clinical trial has a cross-over design. The 20 participants will be randomized to a 14-day bean intervention versus usual care pre- or post-colonoscopy with a cross-over design. The 14-day bean intervention will be preceded by a 3-day ramp-up, acclimation, phase of beans feeding starting at one 1/2 cup of beans for day 1, followed by two 1/2 cups/day for days 2 and 3, then the full dose of three 1/2 cups/day for 14 days afterwards. Participants will be randomized 1:1 using a stratified randomization design. The randomization strata will be sex and presence/absence of metabolic syndrome factors with 1:1 ratio. Investigators anticipate a 20% dropout; therefore, investigators will recruit 25 participants to complete procedures on 20.
Primary purpose: OTHER

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.

Eligibility 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)

Primary outcomes:
measure: Compliance with the bean smoothie intervention
timeFrame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
measure: Tolerance to the bean smoothie intervention
timeFrame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
measure: Effect of the bean smoothie intervention on serum biomarkers of health
timeFrame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
measure: Change in fecal abundance of microbiome genes with bean smoothie intervention
timeFrame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
measure: Change from baseline in the fecal and serum metabolome with bean smoothie intervention
timeFrame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
measure: Impact of bean intervention on colonic tissue RNA markers of health
timeFrame: 2-4 weeks prior to colonoscopy till colonoscopy
Secondary outcomes:
measure: Change from baseline in body composition
timeFrame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
measure: Change from baseline in body mass index (BMI)
timeFrame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
measure: Change from baseline in waist circumference
timeFrame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
measure: Reported change from baseline in fitness level
timeFrame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
measure: Reported change from baseline in and exercise per week
timeFrame: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
affiliation: UC Davis
name: Hisham Hussan, MD
role: PRINCIPAL_INVESTIGATOR
References: