Beans for Gut Microbiome

Overseen By Edward C Deehan, PhD, RD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska Lincoln

Must not be taking: Digestive enzymes, Laxatives

Disqualifiers: Cardiac device, Organ transplant, Gastrointestinal disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants with a BMI of 18.5-24.9 kg/m2 not use oral or injectable medications for most chronic conditions, and those with a BMI of 27.0-39.9 kg/m2 not use medications for diabetes, hypertension, cardiovascular, liver, kidney, gastrointestinal, or autoimmune conditions. If you are taking these medications, you may need to stop.

What data supports the effectiveness of the treatment Five-Bean Mixture, Great Northern Beans, Pink Beans for gut microbiome health?

The research highlights that dietary patterns, including the intake of fiber-rich foods like beans, can shape the gut microbiome by promoting the growth of beneficial bacteria. This can lead to the production of short-chain fatty acids, which help maintain gut health and reduce inflammation. ^{1 2 3 4 5}

Is the Five-Bean Mixture safe for human consumption?

Research on common beans, which are rich in fiber, suggests they can positively impact gut health by altering gut bacteria. While specific safety data for the Five-Bean Mixture isn't provided, beans are generally considered safe for human consumption and may offer health benefits. ^{1 2 6 7 8}

How does the Five-Bean Mixture treatment for gut microbiome differ from other treatments?

The Five-Bean Mixture treatment is unique because it uses a combination of beans rich in fiber and prebiotics to positively impact gut microbiota, unlike other treatments that may not focus on dietary fiber. This approach can modulate the gut environment by enhancing beneficial bacteria and reducing those associated with chronic disease risk, offering a food-based strategy for gut health improvement. ^{8 9 10 11 12}

What is the purpose of this trial?

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.

Research Team

Edward C Deehan, PhD, RD

Principal Investigator

University of Nebraska Lincoln

Eligibility Criteria

This trial is for adults with or without obesity interested in how different types of beans affect gut health. Specific bean classes and mixtures will be compared. Participants should be willing to consume these beans as part of the study.

Inclusion Criteria

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

Exclusion Criteria

Has a cardiac device

Current use of tobacco or vaping

I have taken antibiotics in the past 2 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants consume ½ cup of either Pink Bean, Great Northern Bean, or Bean Mix in Week 1, followed by 1½ cups in Week 2

2 weeks

2 visits (in-person)

Washout Period 1

Participants undergo a washout period to clear previous intervention effects

2 weeks

Treatment Phase 2

Participants consume ½ cup of either Great Northern Bean, Bean Mix, or Pink Bean in Week 1, followed by 1½ cups in Week 2

2 weeks

2 visits (in-person)

Washout Period 2

Participants undergo a second washout period to clear previous intervention effects

2 weeks

Treatment Phase 3

Participants consume ½ cup of either Bean Mix, Pink Bean, or Great Northern Bean in Week 1, followed by 1½ cups in Week 2

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Five-Bean Mixture
• Great Northern Beans
• Pink Beans

Trial Overview The study tests the effects of pink beans, great northern beans, and a five-bean mixture on gut microbiota, blood pressure, metabolism, and gut symptoms to see if different bean types impact health differently.

Participant Groups

Group I: Intervention Scheme 1 Active Control 3 Interventions

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 II: Intervention Scheme 2 Active Control 3 Interventions

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 III: Intervention Scheme 3 Active Control 3 Interventions

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 IV: Intervention Scheme 4 Active Control 3 Interventions

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 V: Intervention Scheme 5 Active Control 3 Interventions

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 VI: Intervention Scheme 6 Active Control 3 Interventions

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

Who Is Running the Clinical Trial?

University of Nebraska Lincoln

Lead Sponsor

Trials

40

Recruited

13,200+

Findings from Research

In a study involving 16 obese individuals, rectal administration of buttermilk processed with medicinal plants led to significant reductions in body measurements and blood glucose levels after 15 days, indicating potential efficacy in weight management.

The treatment resulted in increased bacterial diversity in the gut microbiome on day 16, but this effect diminished by day 45, suggesting that repeated treatments may be necessary for sustained benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rectal administration of buttermilk processed with medicinal plants alters gut microbiome in obese individuals. Mane, S., Dixit, KK., Lathwal, N., et al.[2023]

Bifidobacteria were present in all samples from patients with diverticulitis and inflammatory bowel disease (IBD), while they were found in 76% of colon cancer samples, suggesting a potential link between bifidobacterial presence and these intestinal diseases.

Patients with diverticulitis had significantly higher levels of specific bifidobacterial species, particularly B. longum and B. animalis, compared to those with colon cancer or IBD, indicating that the composition of the gut microbiota may play a role in the pathogenesis of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative and quantitative analyses of the bifidobacterial microbiota in the colonic mucosa of patients with colorectal cancer, diverticulitis and inflammatory bowel disease. Gueimonde, M., Ouwehand, A., Huhtinen, H., et al.[2019]

Incorporating cooked navy bean powder into a high-fat diet for obese mice significantly improved intestinal health and reduced inflammation, as indicated by changes in the fecal microbiome and increased expression of intestinal health markers.

While switching to a low-fat diet also reduced body weight, it did not improve intestinal health or inflammation as effectively as the high-fat diet supplemented with beans, suggesting that beans can enhance health outcomes even in the context of an obesogenic diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navy Bean Supplementation in Established High-Fat Diet-Induced Obesity Attenuates the Severity of the Obese Inflammatory Phenotype. Monk, JM., Wu, W., Lepp, D., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Rectal administration of buttermilk processed with medicinal plants alters gut microbiome in obese individuals. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Human gut bacterial communities are altered by addition of cruciferous vegetables to a controlled fruit- and vegetable-free diet. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Methane and fatty acid metabolism pathways are predictive of Low-FODMAP diet efficacy for patients with irritable bowel syndrome. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Qualitative and quantitative analyses of the bifidobacterial microbiota in the colonic mucosa of patients with colorectal cancer, diverticulitis and inflammatory bowel disease. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Gut Microbiome: Profound Implications for Diet and Disease. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Donor-Dependent and Colon-Region-Dependent Metabolism of (+)-Catechin by Colonic Microbiota in the Simulator of the Human Intestinal Microbial Ecosystem. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Integrating Dietary Data into Microbiome Studies: A Step Forward for Nutri-Metaomics. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Relandscaping the Gut Microbiota with a Whole Food: Dose-Response Effects to Common Bean. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Navy and black bean supplementation primes the colonic mucosal microenvironment to improve gut health. [2019]

10. England pubmed.ncbi.nlm.nih.gov

In vitro fermentation of lupin seeds (Lupinus albus) and broad beans (Vicia faba): dynamic modulation of the intestinal microbiota and metabolomic output. [2015]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Navy Bean Supplementation in Established High-Fat Diet-Induced Obesity Attenuates the Severity of the Obese Inflammatory Phenotype. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Consumption of Cooked Black Beans Stimulates a Cluster of Some Clostridia Class Bacteria Decreasing Inflammatory Response and Improving Insulin Sensitivity. [2021]