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
Sponsors and collaborators
Florida State University
Lead sponsor
Almond Board of California
Collaborator