Almond Butter for Imbalance of Microbes
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Ravinder Nagpal, PhD
Principal Investigator
Florida State University
Are You a Good Fit for This Trial?
This trial is for children aged 6-13 years old who are in grades 1-8 and can speak and read English. Kids with certain health conditions or allergies may not be able to join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants consume a daily snack of almond butter or a control chocolate spread for 8 weeks
Follow-up
Participants are monitored for changes in gut microbiome, cardiometabolic health, and other biomarkers
What Are the Treatments Tested in This Trial?
Interventions
- Creamy Richards 100% Almonds! Creamy Natural Almond Butter
Trial Overview
The study compares the effects of eating almond butter versus a nut-free chocolate spread daily for 8 weeks on gut health, metabolism, and sleep in kids. Participants are randomly assigned to one of the two snack groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in the ALB group will maintain their habitual diet supplemented with a once-daily snack of smooth natural almond butter (Creamy Richards 100% Almonds! Creamy Natural Almond Butter) spread between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers), with a maximum of 16g of almond butter per two crackers. The daily portion of almond butter will be individualized to provide 20% of each participant's estimated daily caloric needs, calculated using Dietary Guidelines for Americans (DGA) age- and sex-specific energy requirements.
Control (CTL) Group: This condition includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread (Cadbury Milk Chocolate) also sandwiched between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers), with the same 16g limit per two crackers. The quantity of chocolate spread provided daily will be equivalent to 20% of each participant's individual daily caloric intake. These caloric needs will be established using Dietary Guidelines for Americans (DGA) based on the participant's age and gender
Find a Clinic Near You
Who Is Running the Clinical Trial?
Florida State University
Lead Sponsor
Almond Board of California
Collaborator
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