Pulse Education and Children

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-13
SponsorFlorida State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 6-13 years old

Ability to speak English

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Education Only

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Education + Pulse Provision ConditionExperimental treatment 2 interventions
Group B: Education Only ConditionActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to Week 6
2

Change in Gut Microbiome Composition and Diversity

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

Time frame
Baseline to Week 6
3

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.

Time frame
Baseline to Week 6
4

Change in Gut Barrier Function Markers

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

Time frame
Baseline to Week 6

Secondary outcomes

1

Sustainability of Pulse Intake

Maintenance of pulse consumption following completion of the intervention, assessed by dietary records and pulse intake questionnaires.

Time frame
Week 12 Follow-Up
2

Change in Blood Lipid Profile

Change in serum lipid concentrations, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.

Time frame
Baseline to Week 6
3

Change in Fasting Blood Glucose

Change in fasting blood glucose concentration measured from blood samples.

Time frame
Baseline to Week 6
4

Change in Blood Metabolomic Profile

Change in circulating metabolomic signatures associated with pulse consumption and metabolic health.

Time frame
Baseline to Week 6

Other outcomes

1

Incidence of Gastrointestinal Symptoms

Frequency and severity of gastrointestinal symptoms, including bloating, abdominal discomfort, gas, diarrhea, and constipation, reported during the intervention period.

Time frame
Baseline to Week 6
2

Incidence of Adverse Events Related to Pulse Consumption

Number and severity of adverse events judged to be related to study participation or pulse consumption.

Time frame
Baseline to Week 6

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