NCT06916936 Effect of Peanut Butter on Gut and Metabolic Health
| NCT ID | NCT06916936 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Florida State University |
| Condition | Dysbiosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-09 |
| Primary Completion | 2027-05 |
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 2025-02-09 with a primary completion date of 2027-05.
⚠ 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
The goal of this is parallel arm, randomized clinical trial is to learn and understand the effect of daily smooth peanut butter consumption on gut and metabolic health of children age 6-13. The main objectives are: Primary Objective: To determine the prebiotic effect of daily smooth peanut butter consumption for eight weeks on gut health, including microbiome-metabolome arrays, gut epithelial/barrier function, and gut transit time, in school-aged children. Secondary Objective(s) 1. To determine the effect of daily smooth peanut butter consumption for eight weeks on metabolic and inflammatory health markers, and measures of sleep quality in school-aged children. 2. To determine the potential mechanisms and feasibility of incorporating peanut butter into the diets of school-aged children as part of healthy, personalized nutrition. Research Intervention(s): Researchers compare two groups to see if there really is an effect of daily smooth peanut butter intake on gut and metabolic health. The two groups are: 1. The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers. 2. The 2nd condition (CTL) includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread, sandwiched between two plain unsalted saltine crackers.
Eligibility 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)
Contact & Investigator
Ravinder Nagpal, Ph.D.
PRINCIPAL INVESTIGATOR
Florida State University
Frequently Asked Questions
Who can join the NCT06916936 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 NCT06916936 currently recruiting?
Yes, NCT06916936 is actively recruiting participants. Contact the research team at cjp23a@fsu.edu for enrollment information.
Where is the NCT06916936 trial being conducted?
This trial is being conducted at Tallahassee, United States.
Who is sponsoring the NCT06916936 clinical trial?
NCT06916936 is sponsored by Florida State University. The principal investigator is Ravinder Nagpal, Ph.D. at Florida State University. The trial plans to enroll 60 participants.