Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health

The Effect of Regular Lentil and Chickpea Intake on Gut Microbiome and Metabolic Health in Healthy Young Adults: A Pilot Randomized Clinical 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dysbiosis
• Intervention / Treatment: Other: Goya Foods - Canned Chickpeas; Other: Goya Foods - Canned Lentils; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State Univresity - The Gut Biome Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Between 18 and 30 years old
• Ability to speak and read in English

Exclusion Criteria:

• Intake of antibiotics in the last 3 months
• Intake of pre/pro/postbiotics in the last 3 months
• Current or past (within the last 6 months) user of tobacco, marijuana, or E-cigarette products
• Cardiovascular disease (heart failure, hypertension, hyper/dyslipidemia, past myocardial infarction)
• Gastrointestinal disease (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, fistulas, suspected or known gastric strictures, gastritis, radiation enteritis, GI bleeding, gastric bezoar, recent GI surgery in the last 3 months, etc..),
• Neurological disorders (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled or insulin dependent diabetes - A1C > 9%).
• Food allergy to study foods (pulses or soy, milk, peanuts, tree nuts)
• 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)
• Class 3 Obesity (BMI > 40 kg/m2)
• Known to be currently pregnant (self-disclosed).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chickpea Condition; 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.	Other: Goya Foods - Canned Chickpeas; Whole-cooked, canned chickpeas supplied by Goya Foods. Provided to participants on a weekly basis in amounts specific to DGAs 2020-2025 and the participant's gender.; Other Names: chickpeas; CHK
Experimental: Lentil Condition; 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.	Other: Goya Foods - Canned Lentils; Whole-cooked, canned lentils supplied by Goya Foods. Provided to participants on a weekly basis in amounts specific to DGAs 2020-2025 and the participant's gender.; Other Names: LEN; Lentils
Active Comparator: Control Condition; 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.	Other: Control; Participants in the Control condition (CTL) will be asked to consume their standard diet while avoiding any and all pulse intake.; Other Names: CTL; Control Condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gut Microbiome Diversity	Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria.	Baseline (day 0) Midpoint (week 4), and endpoint (week 8)
Change in Oral Microbiome Diversity	Collected oral swab samples will be used to determine oral diversity and composition of bacteria in the mouth before and after intervention.	Baseline (day 0), endpoint (week 8)
Change in Fecal Metabolome	The endpoint of fecal metabolomics will be assessed by collecting fecal samples from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the feces. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular peanut butter intake affects metabolic processes and gut health.	Baseline (day 0) and Endpoint (week 8)
Change in Serum Metabolome	The endpoint of serum metabolomics will be assessed by collecting blood serum from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the serum. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular peanut butter intake affects metabolic processes and gut health.	Baseline (day 0), and Endpoint (week 8).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gut Transit Time	Evaluate changes in gut transit time (measured in minutes) after chickpea, lentil or control conditions from baseline to final analysis, using a blue-dye capsule.	Baseline (day 0), Endpoint (week 8)
Change in Waist / Hip Circumference	Evaluate changes in waist and hip circumference (centimeters), as well as waist-hip ratio at each study visit before, after and during chickpea, lentil and control conditions.	Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Lean Mass	Evaluate changes in lean mass (kg). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during experimental (chickpea and lentil) and control conditions.	Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Habitual Dietary Intake	Assess changes in habitual dietary intake via 3-day food logs, analyzed using nutrient analysis software (NDSR).	Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Body Weight	The endpoint of body weight (kg) will be measured at each visit to assess changes in weight before, during and after experimental and control conditions.	Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Lipid Profiles	Relevant biomarkers are to be collected via venous blood samples to determine changes in cardiometabolic health including HDL, LDL, total cholesterol, and triglycerides. All will be expressed in units of mg/dL.	Baseline (day 0), endpoint (week 8)
Change in Biomarkers of Inflammation	Relevant biomarkers are to be collected via venous blood samples to determine changes in inflammation, including but not limited to C-reactive protein (CRP), IL-1 (Interleukin-1), IL-1 beta, IL-6, IL-10, IL-17, IL-23, Tumor Necrosis Factor Alpha (TNF-a), Interferon-gamma (IFN-Y). All will be expressed in units of pg/mL.	Baseline (day 0), Endpoint (week 8)
Change in Biomarkers of Intestinal Barrier Function	Relevant biomarkers are to be collected via venous blood samples to determine changes in intestinal barrier function including LPS (lipopolysaccharides), LBP (lipopolysaccharide binding protein), CD14, Secretory IgA. All will be expressed in units of pg/mL.	Baseline (day 0), endpoint (week 8).
Change in Biomarkers of Appetite	Relevant biomarkers are to be collected via venous blood samples to determine changes in appetite including Insulin, Glucagon, glucagon-like peptide 1 (GLP-1), Adiponectin, Leptin, Ghrelin, and Peptide YY. All will be expressed in units of pg/mL.	Baseline (day 0), endpoint (week 8)
Change in Rested, Seated Blood Pressure	This outcome measure will measure changes in blood pressure taken at rest in the seated position at each visit, before during and after experimental and conrol conditions, expressed as systolic over diastolic blood pressure in units of millimeters of mercury (mmHg).	Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Fasting Blood Glucose	Venous blood samples will be collected to determine changes in fasting blood glucose (expressed as mg/dL).	Baseline (day 0), endpoint (week 8).
Dietary Adherence	Assess adherence to the experimental (chickpeas and lentils) and control condition throughout the study, as determined by dietary adherence logs kept by the participants each week. Adherence is expressed as a daily percent (%) consumption of their assigned condition.	Daily, baseline through endpoint (week 8)
Change in Body Fat Percentage	Evaluate changes in body composition, including fat mass, expressed as a percentage of total weight (%). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during chickpea, lentil or control conditions.	Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Total Body Water	Evaluate changes in body composition, including total body water (TBW) expressed in liters (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during chickpea, lentil or control conditions.	Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Intracellular Fluid	Evaluate changes in body composition, including intracellular fluid (ICF) expressed in liters (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during chickpea, lentil or control conditions.	Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Extracellular Fluid	Evaluate changes in body composition, including extracellular fluid (ECF) expressed in liters (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during chickpea, lentil or control conditions.	Baseline (day 0), midpoint (week 4), endpoint (week 8).

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: United States Department of Agriculture (USDA)
• Investigators: Principal Investigator: Ravinder Nagpal, Ph.D., Florida State University

Publications and helpful links

Helpful Links

• The corresponding official Gut Biome Lab website is linked here

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 30, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: prebiotic; young adults; microbiome; gut; fiber; metabolic health; metagenomic; pulses; lentil; chickpea; transit time
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dysbiosis
• Other Study ID Numbers: STUDY00005525; 58-3060-4-041 (Other Grant/Funding Number: USDA-ARS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified IPD will not be retain past three years, at the time of this submission the researchers does not plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No