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Effect of Peanut Butter on Gut and Metabolic Health

RecruitingNAAges 6 Years - 13 YearsAllFlorida State University
NCT06916936 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 group

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📋 Eligibility rules (as published)
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)
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What it tests

  • Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter
  • Cadbury Milk Chocolate Spread
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Where

1 site
Florida State Univresity - The Gut Biome Lab
Tallahassee, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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