Pulse Education and Children

NCT07648446 | Recruiting

• 2 other identifiers: STUDY0000685958-3060-5-080
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Adherence to Pulse Intake

  Proportion of participants achieving the prescribed pulse intake of ≥1.5 cups per week, assessed using dietary records and pulse meal logs.

  Baseline to Week 6

• Change in Gut Microbiome Composition and Diversity

  Change in fecal microbiome composition and alpha/beta diversity indices measured by microbiome analysis of stool samples.

  Baseline to Week 6

• Change in Fecal Short-Chain Fatty Acids (SCFA) Concentrations

  Change in fecal concentrations of short-chain fatty acids, including acetate, propionate, and butyrate, measured from stool samples.

  Baseline to Week 6

• Change in Gut Barrier Function Markers

  Change in biomarkers of intestinal epithelial/barrier function measured in biological samples.

  Baseline to Week 6

Secondary Outcomes (7)

• Sustainability of Pulse Intake

  Week 12 Follow-Up

• Change in Blood Lipid Profile

  Baseline to Week 6

• Change in Fasting Blood Glucose

  Baseline to Week 6

• Change in Blood Metabolomic Profile

  Baseline to Week 6

• Change in Gut Transit Time

  Baseline to Week 6

Other Outcomes (2)

• Incidence of Gastrointestinal Symptoms

  Baseline to Week 6

• Incidence of Adverse Events Related to Pulse Consumption

  Baseline to Week 6

Study Arms (2)

Education + Pulse Provision Condition

EXPERIMENTAL

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.

Other: Education + Pulse Provision; Other: Cooking Class

Education Only Condition

ACTIVE COMPARATOR

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.

Other: Education Only; Other: Cooking Class

Interventions

Education Only OTHER

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 Only Condition

Education + Pulse Provision OTHER

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.

Education + Pulse Provision Condition

Cooking Class OTHER

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

Education + Pulse Provision Condition; Education Only Condition

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

The Gut Biome Lab

Tallahassee, Florida, 32306, United States

RECRUITING

Related Links

• Gut Biome Lab Website

MeSH Terms

Conditions

Dysbiosis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Ravinder Nagpal, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rayven Nairn, MS, RD

CONTACT

850-644-1829; rsn25b@fsu.edu

FSU College of Education, Health and Human Services

CONTACT

850-644-1829; healthandhumansciences@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)