← Back to Search

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

I am between 35 and 75 years old.

Select...

My BMI is 25 or higher, indicating I am overweight or obese.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

Change from baseline in body composition

Change from baseline in body mass index (BMI)

Change from baseline in median liver fat and stiffness values

+3 more

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 a washout period of 4 weeks after colonoscopy, they then 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 a washout period of 4 weeks 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,494 Total Patients Enrolled

29 Trials studying Obesity

33,544 Patients Enrolled for Obesity

Hisham Hussan, MDPrincipal InvestigatorUC Davis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this study open to octogenarians?

"This clinical trial's inclusion criteria necessitates that participants are between 35 and 75 years old. There is an additional 184 studies specifically for minors, with 672 trials catering to the elderly population."

Answered by AI

Are enrollments for this research endeavor still open?

"This medical trial, first shared on October 27th 2023 and recently modified the same day is actively recruiting patients. Such information can be found at clinicaltrials.gov."

Answered by AI

What is the current capacity of enrollees in this clinical trial?

"Affirmative, the clinicaltrials.gov site confirms that this medical trial is still accepting applications from suitable participants. This experiment was initially published on October 27th 2023 and has been updated to its present state on the same date. 25 individuals are being sought at only one research facility."

Answered by AI

Do I fulfill the eligibility criteria for this experiment?

"For this trial, a cohort of 25 overweight or obese adults between the ages 35 to 75 will be accepted. To qualify for this study, interested participants must have plans for colon cancer screening via standard of care colonoscopy and maintain a Body Mass Index (BMI) above 25 kg/m2."

Answered by AI

What objectives are researchers hoping to achieve through this trial?

"The primary purpose of this trial, spanning a period from several weeks prior to colonoscopy up until 3 months post-procedure, is assessing the efficacy of bean smoothies. Secondary objectives include examining body composition through bioimpedance analysis (BIA), comparing changes in BMI between baseline and after intervention with the usual diet versus the bean smoothie regimen, and evaluating waist circumference before and after ingestion of either dietary plan."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility and Colorectal Benefits of Pulses Supplementation

2023. "Feasibility and Colorectal Benefits of Pulses Supplementation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06032104.