Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health

Not Applicable

Recruiting

• Conditions: Dysbiosis

• Registration Number: NCT06914375
• Lead Sponsor: Florida State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-28
• Study First Submitted: 2025-03-30
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Gut Microbiome Diversity	Baseline (day 0) Midpoint (week 4), and endpoint (week 8)	Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria.
Change in Oral Microbiome Diversity	Baseline (day 0), endpoint (week 8)	Collected oral swab samples will be used to determine oral diversity and composition of bacteria in the mouth before and after intervention.
Change in Fecal Metabolome	Baseline (day 0) and Endpoint (week 8)	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.
Change in Serum Metabolome	Baseline (day 0), and Endpoint (week 8).	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.

Secondary Outcome Measures

Name	Time	Method
Change in Gut Transit Time	Baseline (day 0), Endpoint (week 8)	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.
Change in Waist / Hip Circumference	Baseline (day 0), midpoint (week 4), endpoint (week 8).	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.
Change in Lean Mass	Baseline (day 0), midpoint (week 4), endpoint (week 8).	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.
Change in Habitual Dietary Intake	Baseline (day 0), midpoint (week 4), endpoint (week 8).	Assess changes in habitual dietary intake via 3-day food logs, analyzed using nutrient analysis software (NDSR).
Change in Body Weight	Baseline (day 0), midpoint (week 4), endpoint (week 8).	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.
Change in Lipid Profiles	Baseline (day 0), endpoint (week 8)	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.
Change in Biomarkers of Inflammation	Baseline (day 0), Endpoint (week 8)	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.
Change in Biomarkers of Intestinal Barrier Function	Baseline (day 0), endpoint (week 8).	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.
Change in Biomarkers of Appetite	Baseline (day 0), endpoint (week 8)	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.
Change in Rested, Seated Blood Pressure	Baseline (day 0), midpoint (week 4), endpoint (week 8).	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).
Change in Fasting Blood Glucose	Baseline (day 0), endpoint (week 8).	Venous blood samples will be collected to determine changes in fasting blood glucose (expressed as mg/dL).
Dietary Adherence	Daily, baseline through endpoint (week 8)	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.
Change in Body Fat Percentage	Baseline (day 0), midpoint (week 4), endpoint (week 8).	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.
Change in Total Body Water	Baseline (day 0), midpoint (week 4), endpoint (week 8).	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.
Change in Intracellular Fluid	Baseline (day 0), midpoint (week 4), endpoint (week 8).	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.
Change in Extracellular Fluid	Baseline (day 0), midpoint (week 4), endpoint (week 8).	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.

Trial Locations

Locations (1)

Florida State Univresity - The Gut Biome Lab; 🇺🇸 Tallahassee, Florida, United States