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NCT07648446
Pulse Education and Children
Conditions: Dysbiosis, Cardiometabolic Health Indicators, Education on Feeding and Health Status, Gut Motility
Sex: All
Ages: 6 Years – 13 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Florida State University
Location: The Gut Biome Lab Tallahassee Florida
Summary
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.
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
Source: ClinicalTrials.gov (NCT07648446). StuddyBuddy aggregates publicly available trial information.