Clinical trial Recruiting at 1 site Interventional Ages 6 to 13

Impact of peanut butter on gut and metabolic health in children

Official title: Effect of Peanut Butter on Gut and Metabolic Health in School-Aged Children

Run by Florida State University · NCT06916936 · Data updated 2026-11-12

This study tests if eating smooth peanut butter every day can improve gut and metabolic health in children aged 6 to 13.

More Dysbiosis trials

Quick facts

Study typeInterventional
Ages6 Years to 13 Years
SexAll
Enrollment60 (estimated)
SponsorFlorida State University
Academic / other
Locations1 site (Tallahassee, Florida)
StatusRecruiting
StartedFebruary 9, 2025
Main results expectedMay 2027
Study endsMay 2027
Registry record updatedApril 9, 2026
Trial IDNCT06916936 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 6-13 who are enrolled in elementary or middle school and can read and speak English.

Probably not a fit

Patients with food allergies to peanuts or nuts, gastrointestinal diseases, or those who have recently taken antibiotics or probiotics may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of daily smooth peanut butter consumption on gut and metabolic health in children aged 6 to 13. It is a parallel arm, randomized trial that aims to assess the prebiotic effects of peanut butter over an eight-week period, focusing on gut health metrics such as microbiome composition and gut barrier function. Additionally, the study will evaluate metabolic and inflammatory health markers, as well as sleep quality, to understand the broader implications of incorporating peanut butter into children's diets.

Why it matters

Potential benefit: If successful, this study could provide insights into dietary interventions that improve gut and metabolic health in children.

How similar studies have gone: While there is ongoing research into dietary impacts on gut health, this specific approach using peanut butter is relatively novel and has not been extensively tested in similar studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Enrolled in elementary or middle school (grades 1-8)
* Aged 6-13 years old
* Ability to speak and read in English

Exclusion Criteria:

* Intake of antibiotics in the last 3 months
* Intake of pre/pro/postbiotics in the last 3 months
* Food allergy to study foods

  * Any allergy to nuts or peanuts
* Any allergy to the isocaloric snack (chocolate or wheat)
* Regular consumption of nuts or peanuts greater than 2 servings / week
* Gastrointestinal disease (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%).
* Known to be pregnant (self-disclosed)

Where it's running

  • Florida State Univresity - The Gut Biome Lab
    Tallahassee, Florida, United States
    Recruiting

Study contacts

  • Principal investigator: Ravinder Nagpal, Ph.D. — Florida State University
  • Study coordinator: Cole Patoine, MS, RDN
  • Email: cjp23a@fsu.edu
  • Phone: 850-644-1828

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.