Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health

NCT06914375 | Active Not Recruiting

• 2 other identifiers: STUDY0000552558-3060-4-041
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysbiosis

Keywords

fiber; gut; microbiome; pulses; chickpea; lentil; young adults; transit time; prebiotic; metagenomic; metabolic health

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• Change in Gut Transit Time

  Baseline (day 0), Endpoint (week 8)

• Change in Waist / Hip Circumference

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

• Change in Lean Mass

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

• Change in Habitual Dietary Intake

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

• Change in Body Weight

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

Study Arms (3)

Chickpea Condition

EXPERIMENTAL

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

Lentil Condition

EXPERIMENTAL

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

Control Condition

ACTIVE COMPARATOR

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

Interventions

Goya Foods - Canned Chickpeas OTHER

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.

Also known as: chickpeas, CHK

Chickpea Condition

Goya Foods - Canned Lentils OTHER

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.

Also known as: LEN, Lentils

Lentil Condition

Control OTHER

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

Also known as: CTL, Control Condition

Control Condition

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Florida State University: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Florida State Univresity - The Gut Biome Lab

Tallahassee, Florida, 32306, United States

Location

Related Links

• The corresponding official Gut Biome Lab website is linked here

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ravinder Nagpal, Ph.D.

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 6, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)