Lentils + Chickpeas for Imbalance of Microbes

Overseen By Cole Patoine, MS, RDN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Must not be taking: Antibiotics, Prebiotics, Probiotics, others

Disqualifiers: Cardiovascular, Gastrointestinal, Neurological, Endocrine, others

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

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary goal of this research is to evaluate the effect of daily whole-cooked chickpea and lentil consumption for 8-weeks on gut health, including microbiome-metabolome arrays and gut epithelial/barrier function, in healthy young adults. Secondary Objectives include: * To examine the effect of daily whole-cooked chickpea and lentil consumption for 8-weeks on the measures of metabolic health and inflammation in healthy young adults. * To determine the feasibility of healthy young adults to successfully incorporate and sustain the recommended daily intake of pulses into their diets for eight consecutive weeks Research Interventions: Participants will be asked to consume a normal diet supplemented daily with either A) whole-cooked canned lentils, or B) whole-cooked canned chickpeas. The control condition will be instructed to consume a normal diet while restricting all pulse intake throughout the study.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have been taking antibiotics or pre/pro/postbiotics in the last 3 months, you would not be eligible to participate.

Is it safe to consume lentils and chickpeas for gut health?

Chickpeas and lentils are generally safe for most people, but some individuals may experience allergic reactions, such as asthma or other allergic responses, when exposed to them. It's important to be aware of any personal allergies before consuming these legumes. ^{1 2 3 4 5}

How does the treatment of whole-cooked chickpeas and lentils for microbial imbalance differ from other treatments?

This treatment is unique because it uses whole-cooked chickpeas and lentils, which are natural foods rich in dietary fiber, to help balance gut microbes. Unlike other treatments that might involve medications or supplements, this approach leverages the natural properties of these legumes to promote a healthier gut microbiome, potentially improving intestinal health without the need for synthetic interventions. ^{1 5 6 7 8}

What data supports the effectiveness of the treatment Whole-cooked Chickpeas, Whole-cooked Lentils for Imbalance of Microbes?

Research shows that diets supplemented with chickpeas can positively change the gut bacteria in healthy adults, potentially promoting intestinal health. Additionally, chickpea supplementation in mice reduced inflammation and improved gut health, suggesting that chickpeas may help balance gut microbes. ^{1 3 9 10 11}

Who Is on the Research Team?

Ravinder Nagpal, Ph.D.

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This trial is for healthy young adults interested in the effects of lentils and chickpeas on gut health. Participants should be willing to add these foods to their daily diet or restrict pulse intake if assigned to the control group. Specific eligibility criteria are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

Ability to speak and read in English

Exclusion Criteria

Regular consumption of pulses (>1 cup/wk for males; >0.5 cup/wk for females)

Current heavy alcohol use (≥ 15 drinks / week for men, ≥ 8 drinks / week for women)

I have not taken antibiotics in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume a normal diet supplemented daily with either whole-cooked canned lentils or chickpeas for 8 weeks

8 weeks

Baseline, midpoint (week 4), and endpoint (week 8) visits

Follow-up

Participants are monitored for changes in gut microbiome, metabolic health, and other health markers after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whole-cooked Chickpeas
• Whole-cooked Lentils

Trial Overview The study tests how eating canned chickpeas or lentils every day for 8 weeks impacts gut microbiome and metabolic health compared to a normal diet without pulses. It aims to see if these foods can improve gut function and reduce inflammation.

How Is the Trial Designed?

Group I: Lentil Condition Experimental Treatment 1 Intervention

The lentil condition (LEN) includes a normal diet supplemented weekly with whole-cooked canned chickpeas for 8 weeks (Goya Foods - 80 kcals, 3g fiber, 6g protein per ½ cup). The required intake of chickpeas is determined by stepwise progression of intake according to DGAs 2020-2025 and the participant's gender. Instructions for intake will be provided specifically for each participant and for each week of the study. LEN participants will receive workbooks that contain weekly adherence checklist (dosing diaries), conversion measurements, and copies of RD-prepared recipes outlining various ways to incorporate chickpeas/lentils into their diets each week as meals and/or snacks.

Group II: Chickpea Condition Experimental Treatment 1 Intervention

The chickpea (CHK) condition includes a normal diet supplemented weekly with whole-cooked canned chickpeas for 8 weeks (Goya Foods - 120 kcals, 4g fiber, 6g protein per ½ cup). The required intake of chickpeas is determined by stepwise progression of intake according to DGAs 2020-2025 and the participant's gender. Instructions for intake will be provided specifically for each participant and for each week of the study. CHK participants will receive workbooks that contain weekly adherence checklist (dosing diaries), conversion measurements, and copies of RD-prepared recipes outlining various ways to incorporate chickpeas/lentils into their diets each week as meals and/or snacks.

Group III: Control Condition Active Control 1 Intervention

The control (CTL) condition will be instructed to consume a normal diet while restricting all pulse intake throughout the study. CTL will receive nutrition education materials in custom workbooks on what pulses are and how to avoid intake.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

USDA ARS

Collaborator

Trials

3

Recruited

200+

Published Research Related to This Trial

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Diets supplemented with chickpea or its main oligosaccharide component raffinose modify faecal microbial composition in healthy adults. [2013]

2. Canada pubmed.ncbi.nlm.nih.gov

Chickpea supplementation prior to colitis onset reduces inflammation in dextran sodium sulfate-treated C57Bl/6 male mice. [2023]

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

Effect of short-term consumption of yellow peas as noodles on the intestinal environment: A single-armed pre-post comparative pilot study. [2023]

4. 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]

5. Germany pubmed.ncbi.nlm.nih.gov

Lupin kernel fiber consumption modifies fecal microbiota in healthy men as determined by rRNA gene fluorescent in situ hybridization. [2018]

6. Denmark pubmed.ncbi.nlm.nih.gov

Bronchial asthma induced by chick pea and lentil. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Chickpea (Cicer arietinum) proteins induce allergic responses in nasobronchial allergic patients and BALB/c mice. [2012]

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

UK Chickpea Consumption Doubled from 2008/09-2018/19. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Improving Human Dietary Choices Through Understanding of the Tolerance and Toxicity of Pulse Crop Constituents. [2023]

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

The Effect of Chickpea Dietary Fiber on Lipid Metabolism and Gut Microbiota in High-Fat Diet-Induced Hyperlipidemia in Rats. [2021]

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

The Nutritional Value and Health Benefits of Chickpeas and Hummus. [2018]