Pulse Education and Children
11 de setembro de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: FSU College of Education, Health and Human Services
- Número de telefone: 850-644-1829
- E-mail: healthandhumansciences@fsu.edu
Estude backup de contato
- Nome: Rayven Nairn, MS, RD
- Número de telefone: 850-644-1829
- E-mail: rsn25b@fsu.edu
Locais de estudo
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Florida
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Tallahassee, Florida, Estados Unidos, 32306
- Recrutamento
- The Gut Biome Lab
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Contato:
- Ravinder Nagpal, PhD
- Número de telefone: 850-644-1829
- E-mail: rnagpal@fsu.edu
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Subinvestigador:
- Rayven Nairn, MS, RD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Adherence to Pulse Intake
Prazo: 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
Prazo: Baseline to Week 6
|
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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Sustainability of Pulse Intake
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of Gastrointestinal Symptoms
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Ravinder Nagpal, PhD, Florida State University
Publicações e links úteis
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de outubro de 2026
Conclusão Primária (Estimado)
31 de outubro de 2028
Conclusão do estudo (Estimado)
31 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
7 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de junho de 2026
Primeira postagem (Real)
15 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de setembro de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00006859
- 58-3060-5-080 (Número de outro subsídio/financiamento: USDA ARS)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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