Almonds, Gut Microbiome and Kids

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT07636850
Status
Recruiting
Apply to this trial

Conditions

  • Cardiometabolic Health Indicators
  • Dysbiosis

Eligibility Criteria

Sex
ALL
Age
6 Years - 13 Years
Healthy Volunteers
Accepted

Interventions

  • Creamy Richards 100% Almonds! Creamy Natural Almond Butter — OTHER
    Almond Butter (ALB) Group: Participants in this group will receive a daily snack consisting of a personalized portion 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). The amount of almond butter will be limited to 16g per two crackers; additional crackers will be provided if the personalized portion exceeds this limit.
  • Cadbury Milk Chocolate Spread — OTHER
    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.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Almond Butter Condition
    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.
  • Active Comparator: Control Snack Condition
    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

Primary Outcome Measure

Change in Gut Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Fecal Samples [ Time Frame: Baseline (day 0), midpoint (week 4) and endpoint (week 8) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Gut Biome LabTallahasseeFlorida32306
Ravinder Nagpal, PhD
[email protected]
850-644-1829
Cole Patoine, MS, RD (SUB_INVESTIGATOR)

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By research site
The Gut Biome Lab· Tallahassee, FL

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