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DysbiosisNCT06914375

Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health

A study testing Goya Foods - Canned Chickpeas and Goya Foods - Canned Lentils in people with Dysbiosis, run by Florida State University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Dysbiosis
What is being tested?
Goya Foods - Canned Chickpeas and Goya Foods - Canned Lentils
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
28 Mar 2025to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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%).
Show all 11Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Florida State Univresity - The Gut Biome Lab

    Tallahassee, Florida, 32306

Other trials in United States

About this study

Official title: 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:

Read more
  • 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.

Conditions
Dysbiosis
Being tested
Goya Foods - Canned Chickpeas, Goya Foods - Canned Lentils, Control
Keywords
fiber, gut, microbiome, pulses, chickpea, lentil, young adults, transit time, prebiotic, metagenomic, metabolic health
Medical subject headings
Dysbiosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Goya Foods - Canned ChickpeasOther

    Also called chickpeas, CHK

    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.

  • Goya Foods - Canned LentilsOther

    Also called LEN, 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.

  • ControlOther

    Also called CTL, Control Condition

    Participants in the Control condition (CTL) will be asked to consume their standard diet while avoiding any and all pulse intake.

Study groups in NCT06914375
Study groupRoleWhat they receive
Chickpea ConditionExperimentalThe 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.
Receives: Other: Goya Foods - Canned Chickpeas
Lentil ConditionExperimentalThe 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.
Receives: Other: Goya Foods - Canned Lentils
Control ConditionActive comparatorThe 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.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Gut Microbiome Diversity

    Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria.

    Measured: Baseline (day 0) Midpoint (week 4), and endpoint (week 8)

  2. 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.

    Measured: Baseline (day 0), endpoint (week 8)

  3. 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.

    Measured: Baseline (day 0) and Endpoint (week 8)

  4. 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.

    Measured: Baseline (day 0), and Endpoint (week 8).

Secondary outcomes (16)
  1. 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.

    Measured: Baseline (day 0), Endpoint (week 8)

  2. 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.

    Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).

  3. 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.

    Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).

  4. Change in Habitual Dietary Intake

    Assess changes in habitual dietary intake via 3-day food logs, analyzed using nutrient analysis software (NDSR).

    Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).

  5. 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.

    Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).

  6. 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.

    Measured: Baseline (day 0), endpoint (week 8)

  7. 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.

    Measured: Baseline (day 0), Endpoint (week 8)

  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.

    Measured: Baseline (day 0), endpoint (week 8).

  9. 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.

    Measured: Baseline (day 0), endpoint (week 8)

  10. 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).

    Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).

  11. Change in Fasting Blood Glucose

    Venous blood samples will be collected to determine changes in fasting blood glucose (expressed as mg/dL).

    Measured: Baseline (day 0), endpoint (week 8).

  12. 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.

    Measured: Daily, baseline through endpoint (week 8)

  13. 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.

    Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).

  14. 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.

    Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).

  15. 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.

    Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).

  16. 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.

    Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2025
  2. Study start28 Mar 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06914375
Sponsor's protocol ID
STUDY00005525
Other IDs
58-3060-4-041
Status last verified
Apr 2026
First submitted
30 Mar 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Deidentified IPD will not be retain past three years, at the time of this submission the researchers does not plan to make IPD available

Questions about this trial

What is this clinical trial studying?

A study testing Goya Foods - Canned Chickpeas and Goya Foods - Canned Lentils in people with Dysbiosis, run by Florida State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Gut Microbiome Diversity (time frame: Baseline (day 0) Midpoint (week 4), and endpoint (week 8)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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