| NCT ID | NCT07648446 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Florida State University |
| Condition | Dysbiosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-08-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-08-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Ravinder Nagpal, PhD
PRINCIPAL INVESTIGATOR
Florida State University
Frequently Asked Questions
Who can join the NCT07648446 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 13 Years, studying Dysbiosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07648446 currently recruiting?
Yes, NCT07648446 is actively recruiting participants. Contact the research team at rsn25b@fsu.edu for enrollment information.
Where is the NCT07648446 trial being conducted?
This trial is being conducted at Tallahassee, United States.
Who is sponsoring the NCT07648446 clinical trial?
NCT07648446 is sponsored by Florida State University. The principal investigator is Ravinder Nagpal, PhD at Florida State University. The trial plans to enroll 60 participants.