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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Creamy Richards 100% Almonds! Creamy Natural Almond Butter
Other interventionAlmond 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 interventionControl (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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Almond Butter ConditionExperimental treatment 1 intervention
Group B: Control Snack ConditionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Gut Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Fecal Samples
Freshly voided fecal samples will be collected and DNA extracted using the PowerFecal Pro DNA kit. The V3-V4 hypervariable region of the bacterial 16S ribosomal RNA gene will be PCR-amplified and sequenced. Sequences will be processed using the QIIME2 software package to assess microbial diversity (alpha and beta diversity) and taxonomic composition.
Time frame
Baseline (day 0), midpoint (week 4) and endpoint (week 8)2
Change in Oral Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Oral Swabs
Oral biofilm swabs (omniswab - tongue, palate, cheek/lip lining, gums) and unstimulated saliva will be collected in 5ml tubes. DNA will be extracted and the V3-V4 region of the bacterial 16S ribosomal RNA gene PCR-amplified and sequenced. Sequences will be processed using the QIIME2 software package to assess oral microbial diversity (alpha and beta diversity) and taxonomic composition.
Time frame
Baseline (day 0) and Endpoint (week 8)3
Change in Fecal Metabolome
The endpoint of fecal metabolomics will be assessed by collecting fecal samples from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the feces. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular almond butter intake affects metabolic processes and gut health.
Time frame
Baseline (day 0) and endpoint (week 8)4
Change in Serum Metabolome
The endpoint of serum metabolomics will be assessed by collecting blood serum from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the serum. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular almond butter intake affects metabolic processes and gut health.
Time frame
Baseline (day 0) and endpoint (week 8)Secondary outcomes
1
Change in Gut Transit Time
Evaluate changes in gut transit time after almond butter or control snack consumption from baseline to final analysis, using a blue-dye capsule.
Time frame
Baseline (day 0) and endpoint (week 8)2
Change in Waist/Hip Circumference
Evaluate changes in waist and hip circumference (centimeters), as well as waist-hip ratio at each study visit before, after and during almond butter consumption, compared to a control snack.
Time frame
Baseline (week 0), midpoint (week 4), and endpoint (week 8)3
Change in Habitual Dietary Intake
Assess changes in habitual dietary intake via 3-day food logs, analyzed using nutrient analysis software (NDSR).
Time frame
Baseline (day 0), midpoint (week 4), and endpoint (week 8)4
Change in Body Weight
The endpoint of body weight (kg) will be measured at each visit to assess changes in weight before and after 8 week consumption of almond butter or a control snack spread.
Time frame
Baseline (day 0), midpoint (week 4), endpoint (week 8)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Florida State University
Lead sponsor
Almond Board of California
Collaborator
Source ClinicalTrials.gov