Pulse Education and Children

Официальное название

Enhancing Dietary Perception and Acceptance of Pulses in Children Through an Innovative Nutritional Intervention Program: Bringing Pulses to the Dining Table

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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 preb
• Другое 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

Первичные конечные точки

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

Вторичные конечные точки (7)

• Sustainability of Pulse Intake [Срок оценки: Week 12 Follow-Up]
• Change in Blood Lipid Profile [Срок оценки: Baseline to Week 6]
• Change in Fasting Blood Glucose [Срок оценки: Baseline to Week 6]
• Change in Blood Metabolomic Profile [Срок оценки: Baseline to Week 6]
• Change in Gut Transit Time [Срок оценки: Baseline to Week 6]
• Change in Inflammatory Biomarkers [Срок оценки: Baseline to Week 6]
• Change in Gastrointestinal Tolerance Symptoms [Срок оценки: Baseline to Week 6]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• The Gut Biome Lab — Tallahassee

Идентификаторы

NCT: NCT07648446 · STUDY00006859 · 58-3060-5-080

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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