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NCT07636850

Almonds, Gut Microbiome and Kids

Recruiting
NAAges 6–13InterventionalBasic science
Florida State University
~70 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Creamy Richards 100% Almonds! Creamy Natural Almond ButterCadbury Milk Chocolate Spread

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Gut Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Fecal Samples
Measured over Baseline (day 0), midpoint (week 4) and endpoint (week 8)
+3 more outcomes measured

Conditions

Dysbiosis
Cardiometabolic Health Indicators

Explore related trials

Healthy Volunteers

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Ravinder Nagpal, PhD · PRINCIPAL_INVESTIGATOR · Florida State University

Who to contact

Rayven Nairn, MS, RD
[email protected]
850-644-1829
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Eligibility criteria

Inclusion

Enrolled in elementary or middle school (grades 1-8)
Aged 6-13 years old
Ability to speak and read in English

Exclusion

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)
Regular consumption of nuts or almonds greater than 2 servings / week
Gastrointestinal disease (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome, irritable bowel syndrome, gastroesophageal reflux disease), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C \> 9%).

What this trial measures

  • Change in Gut Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Fecal SamplesBaseline (day 0), midpoint (week 4) and endpoint (week 8)

    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.

  • Change in Oral Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Oral SwabsBaseline (day 0) and Endpoint (week 8)

    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.

  • Change in Fecal MetabolomeBaseline (day 0) and endpoint (week 8)

    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.

  • Change in Serum MetabolomeBaseline (day 0) and endpoint (week 8)

    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.