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Dietary Supplement
Bean Supplementation for Colon Health
N/A
Recruiting
Led By Hisham Hussan, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
35-75 years-old
Overweight or obesity (body mass index ≥ 25 kg/m2)
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Awards & highlights
No Placebo-Only Group
Summary
This trial investigates how beans can improve metabolic & bowel health, leading to better diets & prevention of colon cancer.
Who is the study for?
This trial is for adults aged 35-75 who are overweight or obese and scheduled for a routine colonoscopy. It's not suitable for those with bean intolerance, high bean consumption, pregnancy plans, gastrointestinal diseases like IBD, cancer history, or significant health conditions such as heart disease.
What is being tested?
The study examines the effects of adding Bush's Best Cannellini Beans to the usual diet on metabolic and bowel health in hopes of improving diets and preventing colon cancer.
What are the potential side effects?
Potential side effects may include digestive discomfort due to increased fiber intake from beans, such as bloating, gas, or changes in bowel habits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 35 and 75 years old.
Select...
My BMI is 25 or higher, indicating I am overweight or obese.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any active gut diseases causing poor absorption or chronic diarrhea.
Select...
I have or had cancer, including colorectal cancer that might be inherited.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in the fecal and serum metabolome with bean smoothie intervention
Change in fecal abundance of microbiome genes with bean smoothie intervention
Compliance with the bean smoothie intervention
+3 moreSecondary study objectives
Change from baseline in body composition
Change from baseline in body mass index (BMI)
Change from baseline in waist circumference
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Usual diet then bean smoothieExperimental Treatment2 Interventions
Participants first receive 2 weeks of usual diet before colonoscopy. After colonoscopy, they add bean smoothie to usual diet for 2 weeks
Group II: Bean smoothie then usual dietExperimental Treatment2 Interventions
Participants first receive 2 weeks of adding bean smoothie to usual diet before colonoscopy. After colonoscopy, they receive usual diet for 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual diet
2008
Completed Phase 4
~170
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
946 Previous Clinical Trials
4,756,105 Total Patients Enrolled
30 Trials studying Obesity
33,636 Patients Enrolled for Obesity
Hisham Hussan, MDPrincipal InvestigatorUC Davis