Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-28

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Dysbiosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Goya Foods - Canned Chickpeas

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Goya Foods - Canned Lentils

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Control

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

Intervention Type OTHER

Other Intervention Names

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chickpeas CHK LEN Lentils CTL Control Condition

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes