Clinical trial NCT06914375: Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysbiosis
Keywords: fiber
gut
microbiome
pulses
chickpea
lentil
young adults
transit time
prebiotic
metagenomic
metabolic health
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2025-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Gut Microbiome Diversity
timeFrame: Baseline (day 0) Midpoint (week 4), and endpoint (week 8)
measure: Change in Oral Microbiome Diversity
timeFrame: Baseline (day 0), endpoint (week 8)
measure: Change in Fecal Metabolome
timeFrame: Baseline (day 0) and Endpoint (week 8)
measure: Change in Serum Metabolome
timeFrame: Baseline (day 0), and Endpoint (week 8).
Secondary outcomes:
measure: Change in Gut Transit Time
timeFrame: Baseline (day 0), Endpoint (week 8)
measure: Change in Waist / Hip Circumference
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Lean Mass
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Habitual Dietary Intake
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Body Weight
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Lipid Profiles
timeFrame: Baseline (day 0), endpoint (week 8)
measure: Change in Biomarkers of Inflammation
timeFrame: Baseline (day 0), Endpoint (week 8)
measure: Change in Biomarkers of Intestinal Barrier Function
timeFrame: Baseline (day 0), endpoint (week 8).
measure: Change in Biomarkers of Appetite
timeFrame: Baseline (day 0), endpoint (week 8)
measure: Change in Rested, Seated Blood Pressure
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Fasting Blood Glucose
timeFrame: Baseline (day 0), endpoint (week 8).
measure: Dietary Adherence
timeFrame: Daily, baseline through endpoint (week 8)
measure: Change in Body Fat Percentage
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Total Body Water
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Intracellular Fluid
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Extracellular Fluid
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State Univresity - The Gut Biome Lab
state: Florida
Study officials:
affiliation: Florida State University
name: Ravinder Nagpal, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: