Effect of Peanut Butter on Gut and Metabolic Health

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT06916936
Status
Recruiting
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Conditions

  • Dysbiosis

Eligibility Criteria

Sex
ALL
Age
6 Years - 13 Years
Healthy Volunteers
Accepted

Interventions

  • Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter — OTHER
    Peanut Butter (PB) Group: Participants in this group will receive a daily snack consisting of a personalized portion of smooth peanut butter ("Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter") spread between two plain unsalted saltine crackers ("Unsalted Tops Premium Saltine Crackers"). The amount of peanut butter will be limited to 16g per two crackers, but additional crackers will be provided if the personalized portion exceeds this limit
  • Cadbury Milk Chocolate Spread — OTHER
    Control (CTL) Group: Participants in this group will receive a daily snack consisting of an isocaloric amount of a nut-free, vegetable oil-based chocolate spread ("Cadbury Milk Chocolate") spread between two plain unsalted saltine crackers ("Unsalted Tops Premium Saltine Crackers"). Similar to the peanut butter group, the chocolate spread will be limited to 16g per two crackers, with additional crackers provided if needed.

Study Details

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.

Key Dates

Start date
Feb 9, 2025
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Peanut Butter Condition
    Peanut Butter (PB) Group: This condition involves a normal diet supplemented daily with a personalized portion of smooth peanut butter (Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter) sandwiched between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers). There is a limit of 16g of peanut butter per two crackers. The quantity of peanut butter provided daily will be equivalent to 20% of each participant's individual daily caloric intake. These caloric needs will be established using Dietary Guidelines for Americans (DGA) based on the participant's age and gender.
  • Active Comparator: Control Snack Condition
    Control (CTL) Group: This condition includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread (Cadbury Milk Chocolate) also sandwiched between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers), with the same 16g limit per two crackers. The quantity of chocolate spread provided daily will be equivalent to 20% of each participant's individual daily caloric intake. These caloric needs will be established using Dietary Guidelines for Americans (DGA) based on the participant's age and gender

Primary Outcome Measure

Change in Gut Microbiome Diversity [ Time Frame: Baseline (day 0) Midpoint (week 4), and endpoint (week 8) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida State Univresity - The Gut Biome LabTallahasseeFlorida32306
Ravinder Nagpal, PhD
[email protected]
850-644-1829
Cole Patoine, MS, RDN
[email protected]
Ravinder Nagpal, PhD (PRINCIPAL_INVESTIGATOR)
Cole Patoine, MS, RDN (SUB_INVESTIGATOR)
Saiful Singar, MS (SUB_INVESTIGATOR)
Andrea Lobene, PhD, RDN (SUB_INVESTIGATOR)
Sadio Fenner, MS (SUB_INVESTIGATOR)
Lily Houser (SUB_INVESTIGATOR)

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By research site
Florida State Univresity - The Gut Biome Lab· Tallahassee, FL

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