Colon Cancer Clinical Trial
Feasibility and Colorectal Benefits of Pulses Supplementation
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.
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 bean smoothie that the investigators will provide (Bush's Best Cannellini Beans) 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 the participant colonoscopy. Then, one month after colonoscopy, the participant will switch to the diet he was not assigned in the beginning for two weeks.
Participants' involvement in this research will also include three brief research visits plus a research visit at the time of their scheduled standard-of-care colonoscopy (the research visit will be 30-60 minutes in length, scheduled at close to 2-4 weeks before colonoscopy, day of the colonoscopy, as well as 4-10 and 6-12 weeks after colonoscopy, depending on the 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 obtain some cells using a swab of the participant's 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
Inclusion Criteria:
35-75 years-old
Overweight or obesity (body mass index ≥ 25 kg/m2)
Planned for a standard of care colonoscopy for colon cancer screening
Exclusion Criteria:
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 or suspected or confirmed inherited colorectal cancer
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)
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There is 1 Location for this study
Sacramento California, 95817, United States More Info
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