Feasibility and Colorectal Benefits of Pulses Supplementation
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.
Conditions:
🦠 Colorectal Polyp 🦠 Obesity
🗓️ Study Start (Actual) 27 October 2023
🗓️ Primary Completion (Estimated) September 2025
✅ Study Completion (Estimated) September 2025
👥 Enrollment (Estimated) 25
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Sacramento, California, United States

📋 Eligibility Criteria

Description

  • 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)
Ages Eligible for Study: 30 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 August 2023
  • First Submitted that Met QC Criteria 7 September 2023
  • First Posted 11 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 June 2024
  • Last Update Posted 11 June 2024
  • Last Verified September 2023