Enhancing Dietary Perception and Acceptance of Pulses in Children Through an Innovative Nutritional Intervention Program: Bringing Pulses to the Dining Table
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Adherence to Pulse Intake
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6-13 years old
- •Ability to speak English
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Education + Pulse Provision (Other)
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.
干预措施: Cooking Class (Other)
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.
干预措施: Education Only (Other)
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.
干预措施: Cooking Class (Other)
结局指标
主要结局
Adherence to Pulse Intake
时间窗: Baseline to Week 6
Proportion of participants achieving the prescribed pulse intake of ≥1.5 cups per week, assessed using dietary records and pulse meal logs.
Change in Gut Microbiome Composition and Diversity
时间窗: Baseline to Week 6
Change in fecal microbiome composition and alpha/beta diversity indices measured by microbiome analysis of stool samples.
Change in Fecal Short-Chain Fatty Acids (SCFA) Concentrations
时间窗: Baseline to Week 6
Change in fecal concentrations of short-chain fatty acids, including acetate, propionate, and butyrate, measured from stool samples.
Change in Gut Barrier Function Markers
时间窗: Baseline to Week 6
Change in biomarkers of intestinal epithelial/barrier function measured in biological samples.
次要结局
- 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)
- Change in Inflammatory Biomarkers(Baseline to Week 6)
- Change in Gastrointestinal Tolerance Symptoms(Baseline to Week 6)
研究者
Ravi Nagpal
Principal Investigator
Florida State University