Almonds, Gut Microbiome and Kids

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-13
SponsorFlorida State University

About this trial

This 8-week parallel-arm randomized controlled trial (N=70; ages 6-13) will determine the impact of daily almond butter consumption on gut microbiome composition and function, intestinal barrier integrity, and cardiometabolic health in school-aged children. Participants will be randomized to either a once-daily snack of personalized-portion almond butter (ALB; 16g, Creamy Natural Almond Butter) or an isocaloric nut-free chocolate spread control (CTL; 16g, Cadbury Milk Chocolate), each served on two plain unsalted saltine crackers, added to their habitual diet. The primary outcomes include oro-gut microbial composition and diversity, gut microbial functional capacity and metabolomics (SCFAs, bile acids, amino acid metabolites), and intestinal barrier integrity. Secondary outcomes include fasting cardiometabolic markers, systemic inflammation, appetite-regulatory and metabolic hormones, and sleep-related biomarkers. Feasibility, adherence (weekly logs; serum α-tocopherol), and precision nutrition potential will also be assessed, with stratified analyses by age, sex, BMI, ethnicity, and pubertal stage.

This pilot trial will generate the first multi-omics characterization of almond butter's effects on the gut-immune-metabolic axis in children.

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 the isocaloric snack (chocolate or wheat)

Trial design

Treatments tested in this trial

  • Creamy Richards 100% Almonds! Creamy Natural Almond Butter
  • Cadbury Milk Chocolate Spread

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Florida State University

Lead sponsor

Almond Board of California

Collaborator