Actively Recruiting
Effect of Peanut Butter on Gut and Metabolic Health in School-Aged Children
Led by Florida State University · Updated on 2026-04-09
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Florida State University
Lead Sponsor
T
The Peanut Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of daily smooth peanut butter consumption on the gut and metabolic health of children aged 6 to 13 years. This randomized clinical trial aims primarily to assess the prebiotic impact of peanut butter over eight weeks on gut health, including changes in microbiome-metabolome arrays, gut barrier function, and transit time. Secondary goals include examining effects on metabolic and inflammatory markers and sleep quality, as well as exploring the feasibility of adding peanut butter to children's diets for personalized nutrition. Participants are randomly assigned to one of two groups. The Peanut Butter (PB) group consumes a personalized portion of smooth peanut butter, limited to 16 grams per two crackers, daily between two unsalted saltine crackers. The Control (CTL) group receives an isocaloric amount of a nut-free, vegetable oil-based chocolate spread in the same manner. Both groups receive a daily snack equivalent to 20% of their individual daily caloric intake, based on age and gender guidelines. The intervention lasts for eight weeks. Throughout the study, children undergo assessments at baseline, midpoint (week 4), and endpoint (week 8), including analyses of gut and oral microbiome diversity, serum and fecal metabolome, body measurements, blood pressure, blood glucose, and biomarkers related to inflammation, intestinal barrier function, appetite, and sleep. Dietary adherence is monitored daily. These comprehensive evaluations help researchers understand the biological and metabolic effects of peanut butter consumption in school-aged children over the trial period.
CONDITIONS
Brief Title
Effect of Peanut Butter on Gut and Metabolic Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrolled in elementary or middle school (grades 1-8)
- Aged 6 to 13 years old
- Ability to speak and read in English
You will not qualify if you...
- Intake of antibiotics in the last 3 months
- Intake of pre/pro/postbiotics in the last 3 months
- Food allergy to study foods, including any allergy to nuts, peanuts, chocolate, or wheat
- Regular consumption of nuts or peanuts greater than 2 servings per week
- Gastrointestinal diseases such as ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome, irritable bowel syndrome, or gastroesophageal reflux disease
- Neurological disorders including multiple sclerosis, meningitis, or recent stroke
- Endocrine disorders including uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, or uncontrolled diabetes with A1C greater than 9%
- Known pregnancy (self-disclosed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 8 weeks
Participants follow a normal diet supplemented daily with either peanut butter or a nut-free chocolate spread snack personalized to 20% of their daily caloric intake.
Visits at baseline, midpoint (week 4), and endpoint (week 8) for assessments
Trial Site Locations
Total: 1 location
1
Florida State Univresity - The Gut Biome Lab
Tallahassee, Florida, United States, 32306
Actively Recruiting
Research Team
C
Cole Patoine, MS, RDN
F
FSU College of Education, Health and Human Services
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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