ACTIVE_NOT_RECRUITING

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

Conditions

Dietary Intervention Gut Microbiota Dry Beans Nutritional Microbiology

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-08

Study Completion:2027-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06935435

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.

Ages Eligible for Study:19 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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.

Contacts and Locations

Principal Investigator

Edward C Deehan, PhD, RD

PRINCIPAL_INVESTIGATOR

University of Nebraska Lincoln

Study Locations (Sites)

Nebraska Food for Health Center

Lincoln, Nebraska, 68588

United States

Collaborators and Investigators

Sponsor: University of Nebraska Lincoln

Edward C Deehan, PhD, RD, PRINCIPAL_INVESTIGATOR, University of Nebraska Lincoln

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 Registration Dates

Study Start Date2025-05-08

Study Completion Date2027-04-30

Study Record Updates

Study Start Date2025-05-08

Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

Dry Beans
Gut Microbiota
Nutritional Microbiology

Additional Relevant MeSH Terms

Dietary Intervention
Gut Microbiota