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Effect of Peanut Butter on Gut and Metabolic Health

Florida State University · with The Peanut Institute · NCT06916936

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–13 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
1
Study start
February 9, 2025
Record last updated
April 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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)

  • 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.
  • 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:

  • The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers.
  • 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.

Being studied: Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter; Cadbury Milk Chocolate Spread

Conditions: Dysbiosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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)

Recruiting US locations

  • Florida State Univresity - The Gut Biome Lab

    Tallahassee, FL 32306

    Site contact: Ravinder Nagpal, PhD · 850-644-1829 · rnagpal@fsu.edu

Study contacts (from the official record)

  • Cole Patoine, MS, RDN · 850-644-1828 · cjp23a@fsu.edu
  • FSU College of Education, Health and Human Services · 850-644-1829 · healthandhumansciences@fsu.edu
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Effect of Peanut Butter on Gut and Metabolic Health (NCT06916936) | Bored Studies