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Pulse Education and Children

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 2 months later Aug 31, 2026 → Oct 31, 2028
See other at-risk trials from Florida State University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 31, 2026 to Oct 31, 2028
    • Start date: Aug 1, 2026 to Oct 1, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 7 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07648446
Lead Sponsor Florida State University
Conditions
(from sponsor)		 Dysbiosis, Cardiometabolic Health Indicators, Education on Feeding and Health Status, Gut Motility
Related terms Dysbiosis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov