Effect of Peanut Butter on Gut and Metabolic Health

Official title

Effect of Peanut Butter on Gut and Metabolic Health in School-Aged Children

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) 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.

Interventions

• Other 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
• Other 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.

Primary outcome measures

• Change in Gut Microbiome Diversity [Time frame: Baseline (day 0) Midpoint (week 4), and endpoint (week 8)]
• Change in Oral Microbiome Diversity [Time frame: Baseline (day 0), Endpoint (week 8)]
• Change in Fecal Metabolome [Time frame: Baseline (day 0) and Endpoint (week 8)]
• Change in Serum Metabolome [Time frame: Baseline (day 0), and Endpoint (week 8).]

Secondary outcome measures (12)

• Change in Gut Transit Time [Time frame: Baseline (day 0), and endpoint (week 8)]
• Change in Waist / Hip Circumference [Time frame: baseline (day 0), midpoint (week 4), endpoint (week 8).]
• Change in Habitual Dietary Intake [Time frame: baseline (day 0), midpoint (week 4) and endpoint (week 8).]
• Change in Body Weight [Time frame: Baseline (day 0), midpoint (week 4), endpoint (week 8).]
• Change in Urinary Melatonin [Time frame: Baseline (day 0) Midpoint (week 4), endpoint (week 8).]
• Change in Urinary Serotonin [Time frame: Baseline (day 0) Midpoint (week 4), endpoint (week 8).]
• Change in Body Fat Percentage [Time frame: Baseline (day 0), midpoint (week 4), endpoint (week 8).]
• Change in Lipid Profiles [Time frame: Baseline (day 0), endpoint (week 8)]
• Change in Biomarkers of Inflammation [Time frame: Baseline (day 0), Endpoint (week 8)]
• Change in Biomarkers of Intestinal Barrier Function [Time frame: Baseline (day 0), endpoint (week 8).]
• Change in Lean Mass [Time frame: Baseline (day 0), midpoint (week 4), endpoint (week 8).]
• Change in Biomarkers of Appetite [Time frame: baseline (day 0), endpoint (week 8)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• Florida State Univresity - The Gut Biome Lab — Tallahassee

Identifiers

NCT: NCT06916936 · STUDY00005388 · FA0000072215

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗