Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-02-09
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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.
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
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 6-13 years old
* Ability to speak and read in English
Exclusion Criteria
* 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)
6 Years
13 Years
ALL
Yes
Sponsors
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The Peanut Institute
OTHER
Florida State University
OTHER
Responsible Party
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Ravi Nagpal
Principal Investigator
Principal Investigators
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Ravinder Nagpal, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Florida State University
Locations
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Florida State Univresity - The Gut Biome Lab
Tallahassee, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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The corresponding official Gut Biome Lab website is linked here
Other Identifiers
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FA0000072215
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00005388
Identifier Type: -
Identifier Source: org_study_id
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