Effects of Distinct Nebraska-Dry Bean Market Classes on Gut Microbiota

February 3, 2026 updated by: University of Nebraska Lincoln
Beans are well known for their health benefits. Many of these benefits relate to gut health, as many of the nutrients found in beans support beneficial microbes that live in the gut. However, beans have a lot of genetic diversity. This diversity has led to different bean market classes with different colors, sizes, and nutrient profiles. Differences between bean market classes may trigger different effects on gut microbes and health, but this is poorly understood. The goal of the pilot clinical trial is to make comparisons (1) between two different bean market classes (pink beans, great northern beans) and (2) between a bean mixture (pinto, kidney, black, pink, and great northern beans) and individual bean market classes. The study will assess whether bean market classes differ in their effects on gut microbes, blood pressure, metabolism, and gut symptoms in adults with and without obesity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Bean consumption delivers diverse dietary fibers (resistant starches, non-starch polysaccharides), proteins, polyphenols, and other compounds to the colon, where they serve as substrates for the microbial community (microbiota) that colonizes the gut of humans. However, dry beans exhibit high genetic diversity, corresponding with diverse pigments and nutrients across market classes. It remains poorly understood whether targeted effects on the gut microbiota and health measures are possible with distinct dry bean market classes. The overarching study objective is to perform a randomized, crossover pilot intervention trial in adults to determine the effects of consuming distinct dry bean market classes in isolation or combination on the gut microbiota and health. The study will compare the dose-dependent effects of pink beans, great northern beans, and a five-bean mixture (pinto, kidney, black, pink, and great northern beans) on the gut microbiota, health-relevant metabolites, blood pressure, and immunometabolic markers in adults with and without extra body weight. The pilot study will employ a 3-phase, cross-over design with 2-week intervention periods separated by 2-week washout periods.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Edward C Deehan, PhD, RD
  • Phone Number: 402-472-1862
  • Email: edeehan2@unl.edu

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68588
        • Nebraska Food for Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Aged 19 to 50 years.
  2. Not currently pregnant or planning to become pregnant (Females Only).
  3. Stable body mass index (BMI) of either 18.5-24.9 kg/m2 or 27.0-39.9 kg/m2 for the last month.
  4. Has not made any major dietary changes in the last month.
  5. Able to read and speak English
  6. Requires no legally authorized representative (LAR).
  7. Not institutionalized (e.g., prison, psychological treatment center, etc.).
  8. Able to wear ambulatory blood pressure monitor and limit physical activity over a 24-hr. period.
  9. Have a bowel movement at least every other day.
  10. Able to collect and deliver stool samples to Innovation Campus within 4 hours of collection.
  11. No known allergies or intolerance to beans.
  12. Able to avoid consuming beans during the study, except for the provided beans (up to 1.5 cups/day).

Exclusion Criteria:

  1. Has a cardiac device.
  2. History of organ transplant
  3. History of gastrointestinal surgery or disease diagnosed by a physician that involves the stomach, small, and large intestines (e.g., IBD, IBS, chronic constipation, diverticulosis, gastric bypass).
  4. Recent history of cancer (excluding skin cancer) in the last year.
  5. Current use of tobacco or vaping.
  6. Current or recent use (last 3 weeks) of digestive enzymes, laxatives, dietary fiber, prebiotic, or probiotic supplements.
  7. Medication or supplement regimen or dosage changed within the last 2 months or 3 weeks, respectively.
  8. Taken antibiotics in the last 2 months.
  9. Known allergies or intolerances to beans.
  10. BMI 18.5-24.9 kg/m2 (normoweight): Current use of oral or injectable medications for the treatment of most chronic conditions.
  11. BMI 27.0-39.9 kg/m2 (overweight): Current use of oral or injectable medications for the treatment of diabetes, hypertension, cardiovascular, liver, kidney, gastrointestinal, or autoimmune.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intervention Scheme 1
Intervention Phase 1: Week 1: ½ cup Pink Bean → Week 2: 1½ cups Pink Bean Intervention Phase 2: Week 1: ½ cup Great Northern Bean → Week 2: 1½ cups Great Northern Bean Intervention Phase 3: Week 1: ½ cup Bean Mix → Week 2: 1½ cups Bean Mix
Other: Pink Beans
Pink beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Other: Great Northern Beans
Great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Other: Five-Bean Mixture
Five-bean mixture made of pinto, kidney, black, pink, and great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Active Comparator: Intervention Scheme 2
Intervention Phase 1: Week 1: ½ cup Great Northern Bean → Week 2: 1½ cups Great Northern Bean Intervention Phase 2: Week 1: ½ cup Bean Mix → Week 2: 1½ cups Bean Mix Intervention Phase 3: Week 1: ½ cup Pink Bean → Week 2: 1½ cups Pink Bean
Other: Pink Beans
Pink beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Other: Great Northern Beans
Great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Other: Five-Bean Mixture
Five-bean mixture made of pinto, kidney, black, pink, and great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Active Comparator: Intervention Scheme 3
Intervention Phase 1: Week 1: ½ cup Bean Mix → Week 2: 1½ cups Bean Mix Intervention Phase 2: Week 1: ½ cup Pink Bean → Week 2: 1½ cups Pink Bean Intervention Phase 3: Week 1: ½ cup Great Northern Bean → Week 2: 1½ cups Great Northern Bean
Other: Pink Beans
Pink beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Other: Great Northern Beans
Great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Other: Five-Bean Mixture
Five-bean mixture made of pinto, kidney, black, pink, and great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Active Comparator: Intervention Scheme 4
Intervention Phase 1: Week 1: ½ cup Pink Bean → Week 2: 1½ cups Pink Bean Intervention Phase 2: Week 1: ½ cup Bean Mix → Week 2: 1½ cups Bean Mix Intervention Phase 3: Week 1: ½ cup Great Northern Bean → Week 2: 1½ cups Great Northern Bean
Other: Pink Beans
Pink beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Other: Great Northern Beans
Great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Other: Five-Bean Mixture
Five-bean mixture made of pinto, kidney, black, pink, and great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Active Comparator: Intervention Scheme 5
Intervention Phase 1: Week 1: ½ cup Great Northern Bean → Week 2: 1½ cups Great Northern Bean Intervention Phase 2: Week 1: ½ cup Pink Bean → Week 2: 1½ cups Pink Bean Intervention Phase 3: Week 1: ½ cup Bean Mix → Week 2: 1½ cups Bean Mix
Other: Pink Beans
Pink beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Other: Great Northern Beans
Great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Other: Five-Bean Mixture
Five-bean mixture made of pinto, kidney, black, pink, and great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Active Comparator: Intervention Scheme 6
Intervention Phase 1: Week 1: ½ cup Bean Mix → Week 2: 1½ cups Bean Mix Intervention Phase 2: Week 1: ½ cup Great Northern Bean → Week 2: 1½ cups Great Northern Bean Intervention Phase 3: Week 1: ½ cup Pink Bean → Week 2: 1½ cups Pink Bean
Other: Pink Beans
Pink beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Other: Great Northern Beans
Great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.
Other: Five-Bean Mixture
Five-bean mixture made of pinto, kidney, black, pink, and great northern beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
16S rRNA gene amplicon sequencing of the fecal bacterial community
Time Frame: From baseline to end of weeks 1 and 2 of treatment.
Dose-dependent changes in bacterial composition, and precisely the relative abundance of Faecalibacterium, in fecal samples, as assessed by 16S rRNA gene amplicon sequencing.
From baseline to end of weeks 1 and 2 of treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fecal short-chain fatty acids assessed by gas chromatography
Time Frame: From baseline to end of weeks 1 and 2 of treatment.
Dose-dependent changes in fecal concentrations of short-chain fatty acids as determined by gas chromatography.
From baseline to end of weeks 1 and 2 of treatment.
Gastrointestinal symptoms assessed by the Gastrointestinal Symptom Rating Scale
Time Frame: From baseline to end of weeks 1 and 2 of treatment.
Dose-dependent changes in gastrointestinal symptoms as assessed by the Gastrointestinal Symptom Rating Scale, where the scale is between 0 and 6 and higher values indicate more severe gastrointestinal symptoms.
From baseline to end of weeks 1 and 2 of treatment.
Bowel movement habits assessed by a Bowel Habits Questionnaire
Time Frame: From baseline to end of weeks 1 and 2 of treatment.
Dose-dependent changes in bowel movement (BM) habits as assessed using a Bowel Habits Questionnaire, which has been previously described by Deehan and colleagues. The questionnaire asks participants to record and describe their BMs over three-days to obtain information on BM frequency (number of BM/day), stool consistency (Bristol Stool Scale, 1 [hard] to 7 [liquid]), perceived stool hardness (1 [soft] to 4 [very hard]), straining during bowel movement, discomfort during bowel movement, sensation of incomplete evacuation (1 [none] to 4 [severe]).
From baseline to end of weeks 1 and 2 of treatment.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: From baseline to the end of treatment at 2 weeks.
Changes in 24-hour blood pressure as evaluated by an ambulatory blood pressure monitor.
From baseline to the end of treatment at 2 weeks.
Systematic inflammation assessed by C-reactive protein
Time Frame: From baseline to the end of treatment at 2 weeks.
Changes in circulating levels of C-reactive protein (Unit: mg/L) when collected after fasting.
From baseline to the end of treatment at 2 weeks.
Systematic inflammation assessed by glycosylated acute-phase proteins (GlycA)
Time Frame: From baseline to the end of treatment at 2 weeks.
Changes in circulating levels of glycosylated acute-phase proteins (Unit: umol/L) when collected after fasting.
From baseline to the end of treatment at 2 weeks.
Glucose metabolism assessed by Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time Frame: From baseline to the end of treatment at 2 weeks.
Changes in circulating levels of glucose (Unit: mg/dL) and insulin (Unit: uIU/mL) when collected after fasting. Glucose and insulin values will then be used to calculate the Homeostasis Model Assessment of Insulin Resistance using the equation previously described by Matthews and colleagues.
From baseline to the end of treatment at 2 weeks.
Glucose metabolism assessed by C-peptide
Time Frame: From baseline to the end of treatment at 2 weeks.
Changes in circulating levels of C-peptide (Unit: ng/mL) when collected after fasting.
From baseline to the end of treatment at 2 weeks.
Lipid metabolism assessed by a lipid panel
Time Frame: From baseline to the end of treatment at 2 weeks.
Changes in circulating levels of total cholesterol, high-density lipoprotein, low-density lipoprotein, and triglycerides (Units: mg/dL) when collected after fasting.
From baseline to the end of treatment at 2 weeks.
Percent body fat assessed by bioelectrical impedance analysis
Time Frame: From baseline to the end of treatment at 2 weeks.
Changes in percent body fat assessed by an InBody 770 bioelectrical impedance analyzer. The validity of the InBody 770 bioelectrical impedance analyzer has been previously described by Brewer and colleagues.
From baseline to the end of treatment at 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska Lincoln

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edward C Deehan, PhD, RD, University of Nebraska Lincoln

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UNL-00024307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified gut bacteria sequencing data, along with limited participant information, will be uploaded to the National Center for Biotechnology Information Sequence Read Archive.

IPD Sharing Time Frame

The de-identified gut bacteria sequencing data will be made available upon publication of study findings.

IPD Sharing Access Criteria

Data will be available for download at the National Center for Biotechnology Information Sequence Read Archive.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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