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Pulse Education and Children

RecruitingNAAges 6 Years - 13 YearsAllFlorida State University
NCT07648446 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Education Only
  • Education + Pulse Provision
  • Cooking Class
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Where

1 site
The Gut Biome Lab
Tallahassee, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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