Recruiting

Pulse-Focused Nutrition

Sponsor:

Florida State University

Code:

NCT07648446

Conditions

Dysbiosis

Cardiometabolic Health Indicators

Education on Feeding and Health Status

Gut Motility

Eligibility Criteria

Sex: All

Age: 6 - 13

Healthy Volunteers: Accepted

Interventions

Education Only

Education + Pulse Provision

Cooking Class

Study Details

Brief summary:

This parallel-arm, randomized controlled trial will evaluate the effectiveness of a 6-week pulse-focused nutrition intervention in school-aged children (6-13 years). The study aims to assess adherence to a pulse-based diet providing 1.5 cups of pulses per week and to examine the effects of whole-cooked pulse consumption on gut health, including gut microbiome composition, metabolomic profiles, and gut barrier function. Secondary objectives include evaluating the impact of pulse consumption on markers of metabolic health and inflammation. Forty participants will be randomized to either a pulse-focused nutrition education program with weekly provision of pre-measured pulses (black beans, lentils, and chickpeas) or a pulse-focused nutrition education program in which participants independently procure their own pulses. Participants will follow the assigned intervention for 6 weeks.

Conditions

Dysbiosis

Cardiometabolic Health Indicators

Education on Feeding and Health Status

Gut Motility

Study ID

NCT07648446

Start date

Aug 1, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 13

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Children aged 6-13 years old
  • Ability to speak English

Exclusion Criteria:

  • Frequent pulse consumers (>0.5 cup/week for females and >1 cup / week for males)
  • Antibiotic use in the past 3 months
  • Diagnosed metabolic/gut diseases (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome, irritable bowel syndrome, gastroesophageal reflux disease), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C > 9%).
  • Current use of medications or nutrition supplements
  • Individuals following a specific dietary patten
  • Individuals who gained or lost >5% body weight within the past 6 months
  • Those involved in another study concurrently
  • Any allergies to pulses
  • Intake of pre/pro/postbiotics in the past 3 months

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Education + Pulse Provision Condition

Participants will a six-week pulse education program similar to the education-only group. However, this group will include individualized dietitian counseling alongside written educational materials, a common strategy in dietary education interventions. In addition to education, families will receive free weekly supply of pulses, pre-measured and packaged according to a stepwise intake plan (0.5 cups in Week 1, 1.0 cup in Week 2, and 1.5 cups from Weeks 3-6). The pulses provided will include chickpeas, lentils, and black beans, owing to their prebiotic and gut health benefits as identified in previous research. Families will be asked to prepare three pulse-based meals per week and complete adherence tracking. Pulse provisions are scaled to household size to ensure all members meet intake goals.

active comparator: Education Only Condition

Participants will receive six weekly pulse-focused nutrition sessions via printed handouts, PPTs, and recipe cards covering pulse nutrition, health benefits, and cooking methods. Families will be asked to prepare three pulse-based meals per week following a stepwise intake schedule (0.5 cups in Week 1, 1.0 cup in Week 2, and 1.5 cups from Weeks 3-6) and purchase pulses independently. Adherence is tracked through weekly food logs, checklists, and surveys on child acceptance, meal satisfaction, and preparation feasibility.

Interventions

Education Only

Participants receive six weekly pulse-focused nutrition sessions via printed handouts, PPTs, and recipe cards covering pulse nutrition, health benefits, and cooking methods. Families prepare three pulse-based meals per week following a stepwise intake schedule (0.5 cups in Week 1, 1.0 cup in Week 2, and 1.5 cups from Weeks 3-6) and purchase pulses independently. One of four pulses (lentils, chickpeas, black eye peas, black beans) will be assigned each week.

Education + Pulse Provision

Participants will receive the same six-week pulse education program as the EO group. To further improve success, EP will include individualized dietitian counseling alongside written educational materials, a common strategy in dietary education interventions. In addition to education, EP families will receive free weekly supply of pulses, pre-measured and packaged according to the same stepwise intake plan. The pulses provided will include chickpeas, lentils, and black beans, owing to their prebiotic and gut health benefits as identified in previous research. Families prepare three pulse-based meals per week and complete the same adherence tracking as the EO group. Pulse provisions are scaled to household size to ensure all members meet intake goals.

Cooking Class

The cooking class component will consist of a 4-week family-based cooking series involving both parent(s) and child(ren), with each week focused on a specific pulse: Week 1 (black beans), Week 2 (lentils), Week 3 (black-eyed peas), and Week 4 (chickpeas). Participants will be expected to prepare at least three meals per week using the designated pulse, for a total intake of approximately 1.5 cups per week.

On days when pulses are consumed, participants will complete a Pulse Meal Record using a 24-hour dietary recall format to document intake, preparation method, and portion size. Children will also complete a Child Food Experience Survey after each pulse-containing meal; for children aged 6-8 years, parents may read the survey questions aloud as needed.

Cooking classes will be administered in separate blocks to ensure that EO and EP participants attend distinct sessions. EO participants will independently review the assigned educational materials before each class. EP participants wi

Primary outcome measure

  • Adherence to Pulse Intake [ Time Frame: Baseline to Week 6 ]
  • Change in Gut Microbiome Composition and Diversity [ Time Frame: Baseline to Week 6 ]
  • Change in Fecal Short-Chain Fatty Acids (SCFA) Concentrations [ Time Frame: Baseline to Week 6 ]
  • Change in Gut Barrier Function Markers [ Time Frame: Baseline to Week 6 ]

Central Contacts and Locations

Central contacts

Rayven Nairn, MS, RD

850-644-1829rsn25b@fsu.edu

FSU College of Education, Health and Human Services

850-644-1829healthandhumansciences@fsu.edu

Locations

The Gut Biome Lab

Recruiting

Tallahassee, Florida, United States, 32306

Contacts

Ravinder Nagpal, PhD

850-644-1829rnagpal@fsu.edu

More Information

Sponsor

Florida State University

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • gut
  • git microbiome
  • children
  • pediatric
  • pulses
  • beans
  • metabolomics
  • nutrition education
  • dietary adherence
  • fiber inake
  • plant-based
  • pulse consumption

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida State University on 2026-06-15.