Recruiting

Peanut ButterEffect of Peanut Butter on Gut and Metabolic Health

Sponsor:

Florida State University

Code:

NCT06916936

Conditions

Dysbiosis

Eligibility Criteria

Sex: All

Age: 6 - 13

Healthy Volunteers: Accepted

Interventions

Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter

Cadbury Milk Chocolate Spread

Study Details

Brief 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.

Conditions

Dysbiosis

Study ID

NCT06916936

Start date

Feb 9, 2025

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 6 - 13

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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

Interventions

Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter

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

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.

Primary outcome measure

Change in Gut Microbiome Diversity [ Time Frame: Baseline (day 0) Midpoint (week 4), and endpoint (week 8) ]
Change in Oral Microbiome Diversity [ Time Frame: Baseline (day 0), Endpoint (week 8) ]
Change in Fecal Metabolome [ Time Frame: Baseline (day 0) and Endpoint (week 8) ]
Change in Serum Metabolome [ Time Frame: Baseline (day 0), and Endpoint (week 8). ]

Central Contacts and Locations

Central contacts

Cole Patoine, MS, RDN

850-644-1828 cjp23a@fsu.edu

FSU College of Education, Health and Human Services

850-644-1829 healthandhumansciences@fsu.edu

Locations

Florida State Univresity - The Gut Biome Lab

Recruiting

Tallahassee, Florida, United States, 32306

Contacts

Ravinder Nagpal, PhD

850-644-1829 rnagpal@fsu.edu

Cole Patoine, MS, RDN

cjp23a@fsu.edu

Principal Investigator:

Ravinder Nagpal, PhD

More Information

Sponsor

Florida State University

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Keywords

microbiome
gut
nuts
peanut butter
metabolic health
dysbiosis
metagenomic
sleep quality
prebiotic
children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Florida State University on 2026-04-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.