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

Qualifiers

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

Treatments tested in this trial

  • Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter
  • Cadbury Milk Chocolate Spread

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Florida State University

Lead sponsor

The Peanut Institute

Collaborator