Actively Recruiting
Effect of Peanut Butter on Gut and Metabolic Health
Led by Florida State University · Updated on 2026-04-09
60
Participants Needed
1
Research Sites
115 weeks
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
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.
CONDITIONS
Official 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 6-13 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
- 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 per week
- Gastrointestinal disease such as ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome, irritable bowel syndrome, gastroesophageal reflux disease
- Neurological disorders including multiple sclerosis, meningitis, recent stroke
- Endocrine disorders including uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes (A1C > 9%)
- Known to be pregnant (self-disclosed)
AI-Screening
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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
CONTACT
F
FSU College of Education, Health and Human Services
CONTACT
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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