Effect of Peanut Butter on Gut and Metabolic Health

NCT06916936 | Recruiting

• 2 other identifiers: STUDY00005388FA0000072215
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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.
3. 3.The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers.
4. 4.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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in Gut Microbiome Diversity

  Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria.

  Baseline (day 0) Midpoint (week 4), and endpoint (week 8)

• Change in Oral Microbiome Diversity

  Oral swab samples are collected to determine oral diversity and composition of bacteria in the mouth before and after intervention.

  Baseline (day 0), Endpoint (week 8)

• Change in Fecal Metabolome

  The endpoint of fecal metabolomics will be assessed by collecting fecal samples from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the feces. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular peanut butter intake affects metabolic processes and gut health.

  Baseline (day 0) and Endpoint (week 8)

• Change in Serum Metabolome

  The endpoint of serum metabolomics will be assessed by collecting blood serum from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the serum. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular peanut butter intake affects metabolic processes and gut health.

  Baseline (day 0), and Endpoint (week 8).

Secondary Outcomes (18)

• Change in Gut Transit Time

  Baseline (day 0), and endpoint (week 8)

• Change in Waist / Hip Circumference

  baseline (day 0), midpoint (week 4), endpoint (week 8).

• Change in Habitual Dietary Intake

  baseline (day 0), midpoint (week 4) and endpoint (week 8).

• Change in Body Weight

  Baseline (day 0), midpoint (week 4), endpoint (week 8).

• Change in Urinary Melatonin

  Baseline (day 0) Midpoint (week 4), endpoint (week 8).

Study Arms (2)

Peanut Butter Condition

EXPERIMENTAL

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.

Other: Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter

Control Snack Condition

ACTIVE COMPARATOR

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

Other: Cadbury Milk Chocolate Spread

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

Peanut Butter Condition

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.

Also known as: Control Snack, CTL, Isocaloric Spread

Control Snack Condition

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Enrolled in elementary or middle school (grades 1-8)
• Aged 6-13 years old
• Ability to speak and read in English

You may not qualify if:

• 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)

Sponsors & Collaborators

• Florida State University: lead
• The Peanut Institute: collaborator

Study Sites (1)

Florida State Univresity - The Gut Biome Lab

Tallahassee, Florida, 32306, United States

RECRUITING

Related Links

• The corresponding official Gut Biome Lab website is linked here

MeSH Terms

Conditions

Dysbiosis; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ravinder Nagpal, Ph.D.

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cole Patoine, MS, RDN

CONTACT

850-644-1828; cjp23a@fsu.edu

FSU College of Education, Health and Human Services

CONTACT

850-644-1829; healthandhumansciences@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 8, 2025
• Study Start: February 9, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)