Pulse Education and Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Education Only, Education + Pulse Provision, Cooking Class.
- Who it may be relevant to
- Registry conditions: Dysbiosis, Cardiometabolic Health Indicators, Education on Feeding and Health Status, Gut Motility. Basic parameters: 6 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Enhancing Dietary Perception and Acceptance of Pulses in Children Through an Innovative Nutritional Intervention Program: Bringing Pulses to the Dining Table
Overview
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.
Interventions
- Other 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. - Other 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 - Other 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
Primary outcome measures
- Adherence to Pulse Intake [Time frame: Baseline to Week 6]
- Change in Gut Microbiome Composition and Diversity [Time frame: Baseline to Week 6]
- Change in Fecal Short-Chain Fatty Acids (SCFA) Concentrations [Time frame: Baseline to Week 6]
- Change in Gut Barrier Function Markers [Time frame: Baseline to Week 6]
Secondary outcome measures (7)
- Sustainability of Pulse Intake [Time frame: Week 12 Follow-Up]
- Change in Blood Lipid Profile [Time frame: Baseline to Week 6]
- Change in Fasting Blood Glucose [Time frame: Baseline to Week 6]
- Change in Blood Metabolomic Profile [Time frame: Baseline to Week 6]
- Change in Gut Transit Time [Time frame: Baseline to Week 6]
- Change in Inflammatory Biomarkers [Time frame: Baseline to Week 6]
- Change in Gastrointestinal Tolerance Symptoms [Time frame: Baseline to Week 6]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- The Gut Biome Lab — Tallahassee
Identifiers
NCT: NCT07648446 · STUDY00006859 · 58-3060-5-080