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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
60
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.
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.
Participants in the Control condition (CTL) will be asked to consume their standard diet while avoiding any and all pulse intake.
Florida State Univresity - The Gut Biome Lab
Tallahassee, Florida, United States
RECRUITINGChange in Gut Microbiome Diversity
Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (day 0), and Endpoint (week 8).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
FSU College of Education, Health and Human Services
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