Pulse Education and Children
11 de septiembre de 2026 actualizado por: Ravi Nagpal, Florida State University
Enhancing Dietary Perception and Acceptance of Pulses in Children Through an Innovative Nutritional Intervention Program: Bringing Pulses to the Dining Table
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: FSU College of Education, Health and Human Services
- Número de teléfono: 850-644-1829
- Correo electrónico: healthandhumansciences@fsu.edu
Copia de seguridad de contactos de estudio
- Nombre: Rayven Nairn, MS, RD
- Número de teléfono: 850-644-1829
- Correo electrónico: rsn25b@fsu.edu
Ubicaciones de estudio
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Florida
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Tallahassee, Florida, Estados Unidos, 32306
- Reclutamiento
- The Gut Biome Lab
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Contacto:
- Ravinder Nagpal, PhD
- Número de teléfono: 850-644-1829
- Correo electrónico: rnagpal@fsu.edu
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Sub-Investigador:
- Rayven Nairn, MS, RD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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 |
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Comparador activo: 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.
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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
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adherence to Pulse Intake
Periodo de tiempo: Baseline to Week 6
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Proportion of participants achieving the prescribed pulse intake of ≥1.5 cups per week, assessed using dietary records and pulse meal logs.
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Baseline to Week 6
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Change in Gut Microbiome Composition and Diversity
Periodo de tiempo: Baseline to Week 6
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Change in fecal microbiome composition and alpha/beta diversity indices measured by microbiome analysis of stool samples.
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Baseline to Week 6
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Change in Fecal Short-Chain Fatty Acids (SCFA) Concentrations
Periodo de tiempo: Baseline to Week 6
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Change in fecal concentrations of short-chain fatty acids, including acetate, propionate, and butyrate, measured from stool samples.
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Baseline to Week 6
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Change in Gut Barrier Function Markers
Periodo de tiempo: Baseline to Week 6
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Change in biomarkers of intestinal epithelial/barrier function measured in biological samples.
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Baseline to Week 6
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sustainability of Pulse Intake
Periodo de tiempo: Week 12 Follow-Up
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Maintenance of pulse consumption following completion of the intervention, assessed by dietary records and pulse intake questionnaires.
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Week 12 Follow-Up
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Change in Blood Lipid Profile
Periodo de tiempo: Baseline to Week 6
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Change in serum lipid concentrations, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.
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Baseline to Week 6
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Change in Fasting Blood Glucose
Periodo de tiempo: Baseline to Week 6
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Change in fasting blood glucose concentration measured from blood samples.
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Baseline to Week 6
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Change in Blood Metabolomic Profile
Periodo de tiempo: Baseline to Week 6
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Change in circulating metabolomic signatures associated with pulse consumption and metabolic health.
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Baseline to Week 6
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Change in Gut Transit Time
Periodo de tiempo: Baseline to Week 6
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Evaluate changes in gut transit time after pulse consumption for 6 weeks from baseline to final analysis, using a blue-dye capsule.
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Baseline to Week 6
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Change in Inflammatory Biomarkers
Periodo de tiempo: Baseline to Week 6
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Change in circulating and/or fecal biomarkers of inflammation.
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Baseline to Week 6
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Change in Gastrointestinal Tolerance Symptoms
Periodo de tiempo: Baseline to Week 6
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Evaluate changes in gastrointestinal tolerance symptoms to pulses like bloating, gas, and/or stomach cramping using a post-meal survey.
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Baseline to Week 6
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Gastrointestinal Symptoms
Periodo de tiempo: Baseline to Week 6
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Frequency and severity of gastrointestinal symptoms, including bloating, abdominal discomfort, gas, diarrhea, and constipation, reported during the intervention period.
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Baseline to Week 6
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Incidence of Adverse Events Related to Pulse Consumption
Periodo de tiempo: Baseline to Week 6
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Number and severity of adverse events judged to be related to study participation or pulse consumption.
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Baseline to Week 6
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ravinder Nagpal, PhD, Florida State University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
31 de octubre de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
7 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de junio de 2026
Publicado por primera vez (Actual)
15 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00006859
- 58-3060-5-080 (Otro número de subvención/financiamiento: USDA ARS)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .