RECRUITING

Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-03-28
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06914375

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between 18 and 30 years old
  2. * Ability to speak and read in English
  1. * Intake of antibiotics in the last 3 months
  2. * Intake of pre/pro/postbiotics in the last 3 months
  3. * Current or past (within the last 6 months) user of tobacco, marijuana, or E-cigarette products
  4. * Cardiovascular disease (heart failure, hypertension, hyper/dyslipidemia, past myocardial infarction)
  5. * 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..),
  6. * 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%).
  7. * Food allergy to study foods (pulses or soy, milk, peanuts, tree nuts)
  8. * Regular consumption of pulses (\>1 cup/wk for males; \>0.5 cup/wk for females)
  9. * Current heavy alcohol use (≥ 15 drinks / week for men, ≥ 8 drinks / week for women)
  10. * Class 3 Obesity (BMI \> 40 kg/m2)
  11. * Known to be currently pregnant (self-disclosed).

Contacts and Locations

Study Contact

Cole Patoine, MS, RDN
CONTACT
850-644-1828
cjp23a@fsu.edu
FSU College of Education, Health and Human Services
CONTACT
850-644-1829
healthandhumansciences@fsu.edu

Principal Investigator

Ravinder Nagpal, Ph.D.
PRINCIPAL_INVESTIGATOR
Florida State University

Study Locations (Sites)

Florida State Univresity - The Gut Biome Lab
Tallahassee, Florida, 32306
United States

Collaborators and Investigators

Sponsor: Florida State University

  • Ravinder Nagpal, Ph.D., PRINCIPAL_INVESTIGATOR, Florida State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-28
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-03-28
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Dysbiosis