Effect of Peanut Butter on Gut and Metabolic Health
ConditionDysbiosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-13
SponsorFlorida State University
About this trial
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
This trial accepts healthy volunteersQualifiers
Enrolled in elementary or middle school (grades 1-8)
Aged 6-13 years old
Ability to speak and read in English
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter
Other interventionPeanut 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 interventionControl (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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Peanut Butter ConditionExperimental treatment 1 intervention
Group B: Control Snack ConditionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Gut Microbiome Diversity
Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria.
Time frame
Baseline (day 0) Midpoint (week 4), and endpoint (week 8)2
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.
Time frame
Baseline (day 0), Endpoint (week 8)3
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.
Time frame
Baseline (day 0) and Endpoint (week 8)4
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.
Time frame
Baseline (day 0), and Endpoint (week 8).Secondary outcomes
1
Change in Gut Transit Time
Evaluate changes in gut transit time after peanut butter or control snack consumption from baseline to final analysis, using a blue-dye capsule.
Time frame
Baseline (day 0), and endpoint (week 8)2
Change in Waist / Hip Circumference
Evaluate changes in waist and hip circumference (centimeters), as well as waist-hip ratio at each study visit before, after and during peanut butter consumption, compared to a control snack.
Time frame
baseline (day 0), midpoint (week 4), endpoint (week 8).3
Change in Habitual Dietary Intake
Assess changes in habitual dietary intake via 3-day food logs, analyzed using nutrient analysis software (NDSR).
Time frame
baseline (day 0), midpoint (week 4) and endpoint (week 8).4
Change in Body Weight
the endpoint of body weight (kg) will be measured at each visit to assess changes in weight before and after 8 week consumption peanut butter or a control snack spread.
Time frame
Baseline (day 0), midpoint (week 4), endpoint (week 8).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Florida State University
Lead sponsor
The Peanut Institute
Collaborator
Source ClinicalTrials.gov