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

NCT06935435 | Active Not Recruiting

• 1 other identifier: UNL-00024307
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dietary Intervention; Gut Microbiota

Keywords

Dry Beans; Gut Microbiota; Nutritional Microbiology

Outcome Measures

Primary Outcomes (1)

• 16S rRNA gene amplicon sequencing of the fecal bacterial community

  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 Outcomes (3)

• Fecal short-chain fatty acids assessed by gas chromatography

  From baseline to end of weeks 1 and 2 of treatment.

• Gastrointestinal symptoms assessed by the Gastrointestinal Symptom Rating Scale

  From baseline to end of weeks 1 and 2 of treatment.

• Bowel movement habits assessed by a Bowel Habits Questionnaire

  From baseline to end of weeks 1 and 2 of treatment.

Other Outcomes (7)

• Blood pressure

  From baseline to the end of treatment at 2 weeks.

• Systematic inflammation assessed by C-reactive protein

  From baseline to the end of treatment at 2 weeks.

• Systematic inflammation assessed by glycosylated acute-phase proteins (GlycA)

  From baseline to the end of treatment at 2 weeks.

Study Arms (6)

Intervention Scheme 1

ACTIVE COMPARATOR

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; Other: Great Northern Beans; Other: Five-Bean Mixture

Intervention Scheme 2

ACTIVE COMPARATOR

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; Other: Great Northern Beans; Other: Five-Bean Mixture

Intervention Scheme 3

ACTIVE COMPARATOR

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; Other: Great Northern Beans; Other: Five-Bean Mixture

Intervention Scheme 4

ACTIVE COMPARATOR

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; Other: Great Northern Beans; Other: Five-Bean Mixture

Intervention Scheme 5

ACTIVE COMPARATOR

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; Other: Great Northern Beans; Other: Five-Bean Mixture

Intervention Scheme 6

ACTIVE COMPARATOR

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; Other: Great Northern Beans; Other: Five-Bean Mixture

Interventions

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.

Intervention Scheme 1; Intervention Scheme 2; Intervention Scheme 3; Intervention Scheme 4; Intervention Scheme 5; Intervention Scheme 6

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.

Intervention Scheme 1; Intervention Scheme 2; Intervention Scheme 3; Intervention Scheme 4; Intervention Scheme 5; Intervention Scheme 6

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.

Intervention Scheme 1; Intervention Scheme 2; Intervention Scheme 3; Intervention Scheme 4; Intervention Scheme 5; Intervention Scheme 6

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska Lincoln: lead

Study Sites (1)

Nebraska Food for Health Center

Lincoln, Nebraska, 68588, United States

Location

Related Publications (3)

• Deehan EC, Yang C, Perez-Munoz ME, Nguyen NK, Cheng CC, Triador L, Zhang Z, Bakal JA, Walter J. Precision Microbiome Modulation with Discrete Dietary Fiber Structures Directs Short-Chain Fatty Acid Production. Cell Host Microbe. 2020 Mar 11;27(3):389-404.e6. doi: 10.1016/j.chom.2020.01.006. Epub 2020 Jan 30.

  PMID: 32004499 BACKGROUND

• Brewer GJ, Blue MNM, Hirsch KR, Saylor HE, Gould LM, Nelson AG, Smith-Ryan AE. Validation of InBody 770 bioelectrical impedance analysis compared to a four-compartment model criterion in young adults. Clin Physiol Funct Imaging. 2021 Jul;41(4):317-325. doi: 10.1111/cpf.12700. Epub 2021 Apr 1.

  PMID: 33752260 BACKGROUND

• Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.

  PMID: 3899825 BACKGROUND

Study Officials

• Edward C Deehan, PhD, RD

  University of Nebraska Lincoln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study intervention will consist of individuals consuming daily, precooked and prepackaged dry beans over three 2-week intervention periods. The amount of beans to consume will be ½ cups/day during week 1 and 1 ½ cups/day during week 2. The three bean interventions will be i) pink beans, ii) great northern beans, and iii) a five-bean mixture (pinto, kidney, black, pink, and great northern beans). The participants will be asked to consume all bean interventions in random order. The beans will be added to the participants' usual diet.

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 20, 2025
• Study Start: May 8, 2025
• Primary Completion: January 28, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: The de-identified gut bacteria sequencing data will be made available upon publication of study findings.
• Access Criteria: Data will be available for download at the National Center for Biotechnology Information Sequence Read Archive.

Locations

US (1)