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Study identifier: NCT07636850 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Almonds, Gut Microbiome and Kids

Condition: Dysbiosis · Cardiometabolic Health Indicators  ·  Sponsor: Florida State University

PhaseNA
Planned participants70
Who can joinAll sexes, 6 Years to 13 Years
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Rayven Nairn, MS, RD  ·  850-644-1829  ·  rsn25b@fsu.edu

FSU College of Education, Health and Human Services  ·  850-644-1829  ·  healthandhumansciences@fsu.edu

Always discuss trial participation with your own doctor first.

Locations (1)

The Gut Biome LabTallahassee, Florida, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07636850