Effect of Peanut Butter on Gut and Metabolic Health

Last updated: April 1, 2025
Sponsor: Florida State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Cadbury Milk Chocolate Spread

Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter

Clinical Study ID

NCT06916936
STUDY00005388
FA0000072215
  • Ages 6-13
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Enrolled in elementary or middle school (grades 1-8)

  • Aged 6-13 years old

  • Ability to speak and read in English

Exclusion

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 (multiplesclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroiddisorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes

  • A1C > 9%).

  • Known to be pregnant (self-disclosed)

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Cadbury Milk Chocolate Spread
Phase:
Study Start date:
February 09, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Florida State Univresity - The Gut Biome Lab

    Tallahassee, Florida 32306
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.