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

NCT ID: NCT06935435

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-08
• Study Completion Date: 2027-04-30

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.

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.

Conditions

Dietary Intervention; Gut Microbiota

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Pink Beans

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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 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

Group Type: ACTIVE_COMPARATOR

Pink Beans

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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 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

Group Type: ACTIVE_COMPARATOR

Pink Beans

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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 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

Group Type: ACTIVE_COMPARATOR

Pink Beans

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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 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

Group Type: ACTIVE_COMPARATOR

Pink Beans

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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 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

Group Type: ACTIVE_COMPARATOR

Pink Beans

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska Lincoln

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward C Deehan, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska Lincoln

Locations

Nebraska Food for Health Center

Lincoln, Nebraska, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Edward C Deehan, PhD, RD

Role: CONTACT

edeehan2@unl.edu

402-472-1862

Facility Contacts

Edward C Deehan, PhD, RD

Role: primary

edeehan2@unl.edu

402-472-1862

References

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.

Reference Type: BACKGROUND

PMID: 32004499 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33752260 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3899825 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

UNL-00024307

Identifier Type: -

Identifier Source: org_study_id