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