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NCT Number: NCT06935435

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nebraska Food for Health Center

Lincoln, Nebraska, 68588, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Has a cardiac device.
  • History of organ transplant
  • 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).
  • Recent history of cancer (excluding skin cancer) in the last year.
  • Current use of tobacco or vaping.
  • Current or recent use (last 3 weeks) of digestive enzymes, laxatives, dietary fiber, prebiotic, or probiotic supplements.
  • Medication or supplement regimen or dosage changed within the last 2 months or 3 weeks, respectively.
  • Taken antibiotics in the last 2 months.
  • Known allergies or intolerances to beans.
  • BMI 18.5-24.9 kg/m2 (normoweight): Current use of oral or injectable medications for the treatment of most chronic conditions.
  • 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.

Treatment and study plan

Pink Beans

Other

Pink beans consumed for 2 weeks, at an amount of ½ cup/day for week 1 and 1 ½ cups/day for week 2.

Great Northern Beans

Other

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.

Five-Bean Mixture

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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]).

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Nebraska Lincoln

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 20, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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