Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health

Florida State University

Status: Enrolling

Conditions: Dysbiosis

Treatments: Other: Control; Other: Goya Foods - Canned Chickpeas; Other: Goya Foods - Canned Lentils

Study type: Interventional

Funder types: Other

Identifiers

NCT06914375

STUDY00005525

58-3060-4-041 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Chickpea Condition

Experimental group

Description:

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.

Treatment:

Other: Goya Foods - Canned Chickpeas

Lentil Condition

Experimental group

Description:

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.

Treatment:

Other: Goya Foods - Canned Lentils

Control Condition

Active Comparator group

Description:

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.

Treatment:

Other: Control