Clinical trial NCT06916936: Effect of Peanut Butter on Gut and Metabolic Health
Official title: Effect of Peanut Butter on Gut and Metabolic Health in School-Aged Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysbiosis
Keywords: microbiome
gut
nuts
peanut butter
metabolic health
dysbiosis
metagenomic
sleep quality
prebiotic
children
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: The Peanut Institute
First posted: 2025-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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)

Primary outcomes:
measure: Change in Gut Microbiome Diversity
timeFrame: Baseline (day 0) Midpoint (week 4), and endpoint (week 8)
measure: Change in Oral Microbiome Diversity
timeFrame: Baseline (day 0), Endpoint (week 8)
measure: Change in Fecal Metabolome
timeFrame: Baseline (day 0) and Endpoint (week 8)
measure: Change in Serum Metabolome
timeFrame: Baseline (day 0), and Endpoint (week 8).
Secondary outcomes:
measure: Change in Gut Transit Time
timeFrame: Baseline (day 0), and endpoint (week 8)
measure: Change in Waist / Hip Circumference
timeFrame: baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Habitual Dietary Intake
timeFrame: baseline (day 0), midpoint (week 4) and endpoint (week 8).
measure: Change in Body Weight
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Urinary Melatonin
timeFrame: Baseline (day 0) Midpoint (week 4), endpoint (week 8).
measure: Change in Urinary Serotonin
timeFrame: Baseline (day 0) Midpoint (week 4), endpoint (week 8).
measure: Change in Body Fat Percentage
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Lipid Profiles
timeFrame: Baseline (day 0), endpoint (week 8)
measure: Change in Biomarkers of Inflammation
timeFrame: Baseline (day 0), Endpoint (week 8)
measure: Change in Biomarkers of Intestinal Barrier Function
timeFrame: Baseline (day 0), endpoint (week 8).
measure: Change in Lean Mass
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Biomarkers of Appetite
timeFrame: baseline (day 0), endpoint (week 8)
measure: Change in Rested, Seated Blood Pressure
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Fasting Blood Glucose
timeFrame: Baseline (day 0), endpoint (week 8).
measure: Dietary Adherence
timeFrame: Daily, baseline through endpoint (week 8)
measure: Change in Total Body Water
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Intracellular Fluid
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
measure: Change in Extracellular Fluid
timeFrame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State Univresity - The Gut Biome Lab
state: Florida
Study officials:
affiliation: Florida State University
name: Ravinder Nagpal, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: