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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of beans affect gut health, blood pressure, metabolism, and gut symptoms. Researchers will compare the effects of pink beans, great northern beans, and a mix of five different beans (referred to as the Five-Bean Mixture) to determine their impact on the gut. Adults with stable weight over the past month and regular bowel movements are suitable candidates. Participants should not have bean allergies or recent major dietary changes. As an unphased trial, this study provides participants the opportunity to contribute to valuable research on dietary impacts on health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that beans are generally safe and offer health benefits. Research on navy beans, similar to the beans in this trial, suggests that adding beans to one's diet is safe and can improve gut health. The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) trial found that eating one cup of navy beans most days of the week safely and effectively boosts gut health.

While specific safety data for pink beans, great northern beans, and the five-bean mixture is not yet available, beans are known to be nutritious and safe to eat. Pink beans and great northern beans are rich in nutrients and may help maintain a healthy gut. The trial is in an early stage, often called "Not Applicable," indicating likely safety, but specific safety data from this study is not yet available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for gut microbiome health rely on probiotics or dietary supplements to introduce beneficial bacteria. But researchers are excited about using beans, specifically Great Northern Beans, Pink Beans, and a Five-Bean Mixture, to naturally boost gut health. Unlike typical supplements, these beans are rich in fiber and bioactive compounds, which could promote a more balanced gut microbiome by feeding existing beneficial bacteria. This natural approach may offer a sustainable, food-based strategy to enhance gut health, potentially improving digestion and overall well-being.

What evidence suggests that this trial's treatments could be effective for gut health?

Research shows that eating beans can improve gut health by supporting beneficial bacteria in the stomach. In this trial, participants will consume various types of beans, including Great Northern Beans, Pink Beans, and a Five-Bean Mixture, in different intervention schemes. Studies have found that eating a cup of beans daily, such as Great Northern or Pink beans, can increase the variety of beneficial gut bacteria and improve health markers related to metabolism. Specifically, early results for Pink beans suggest they boost gut bacteria variety, though this effect might decrease if consumption stops. The Five-Bean Mixture, which includes beans like pinto and kidney, may offer similar benefits by providing a mix of nutrients that support a healthy gut. Overall, beans are generally safe and positively affect gut health. ^{1 2 3 5 6}

Who Is on the Research Team?

Edward C Deehan, PhD, RD

Principal Investigator

University of Nebraska Lincoln

Are You a Good Fit for This Trial?

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

Known allergies or intolerances to beans

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/beans-for-gut-microbiome-699e7

Beans for Gut Microbiome 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6921460/

a randomized crossover dietary intervention of dry beans ... To examine the effect of increased consumption of dry beans on the gut microbiome and blood biomarkers in high-risk CR patients otherwise ...

3. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(23)00439-5/fulltext

insights from the BE GONE trial - eBioMedicine Modulating a prebiotic food source influences inflammation and immune-regulating gut microbes and metabolites: insights from the BE GONE trial

4. hcplive.com hcplive.com/view/be-gone-trial-dietary-bean-intervention-enhances-gut-microbiome

BE GONE Trial: Dietary Bean Intervention Enhances Gut ... Adding navy beans to one's usual diet may be a viable dietary strategy for modulating the gut microbiome and regulating host markers associated with metabolic ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06935435/effects-of-distinct-nebraska-dry-bean-market-classes-on-gut-microbiota

Effects of Distinct Nebraska-Dry Bean Market Classes ... The study will compare the dose-dependent effects of pink beans, great northern beans, and a five-bean mixture (pinto, kidney, black, pink, and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405457724001979

Impact of a legumes diet on the human gut microbiome ... This paper addresses a pilot small cohort to probe for metabolic aspects of the interplay between legumes intake, human metabolism and gut microbiota.