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Almonds, Gut Microbiome and Kids

11 settembre 2026 aggiornato da: Ravi Nagpal, Florida State University

Nutritional Impact of Almond Butter on Gut Microbiome and Cardiometabolic Health in School-Aged Children: A Novel and Timely Pilot Randomized Controlled 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

70

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Rayven Nairn, MS, RD
  • Numero di telefono: 850-644-1829
  • Email: rsn25b@fsu.edu

Luoghi di studio

  • Stati Uniti
    • Florida
      • Tallahassee, Florida, Stati Uniti, 32306
        • Reclutamento
        • The Gut Biome Lab
        • Contatto:
          • Ravinder Nagpal, PhD
          • Numero di telefono: 850-644-1829
          • Email: rnagpal@fsu.edu
        • Sub-investigatore:
          • Cole Patoine, MS, RD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

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

Exclusion Criteria:

  • 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 nuts or almonds

  • 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%).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Controllo Snack Condizioni
Gruppo di controllo (CTL): questa condizione include una dieta normale integrata quotidianamente con una quantità isocalorica di una diffusione di cioccolato a base di olio vegetale senza noci (cioccolato al latte Cadbury) anche tra due cracker saltini non sale (cracker saltini premium), con lo stesso limite 16G per due cracker. La quantità di diffusione del cioccolato fornita quotidianamente sarà equivalente al 20% dell'apporto calorico giornaliero individuale di ciascun partecipante. Queste esigenze caloriche saranno stabilite utilizzando linee guida dietetiche per gli americani (DGA) in base all'età e al sesso del partecipante
Altro: Cadbury Milk Chocolate Displed
Gruppo di controllo (CTL): i partecipanti a questo gruppo riceveranno uno spuntino giornaliero costituito da una quantità isocalorica di cioccolato a base di olio vegetale e senza noci ("cioccolato di latte Cadbury") tra due cracker saltini non sale ("crack saltine premium"). Simile al gruppo di burro di arachidi, la diffusione del cioccolato sarà limitata a 16 g per due cracker, con ulteriori cracker forniti se necessario.
Altri nomi:
  • Controllo
  • CTL
  • Isocaloric spread
Sperimentale: 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.
Altro: Creamy Richards 100% Almonds! Creamy Natural Almond Butter
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.
Altri nomi:
  • CAMICE
  • Almond Butter

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Gut Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Fecal Samples
Lasso di tempo: Baseline (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.
Baseline (day 0), midpoint (week 4) and endpoint (week 8)
Change in Oral Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Oral Swabs
Lasso di tempo: Baseline (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.
Baseline (day 0) and Endpoint (week 8)
Change in Fecal Metabolome
Lasso di tempo: Baseline (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.
Baseline (day 0) and endpoint (week 8)
Change in Serum Metabolome
Lasso di tempo: Baseline (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.
Baseline (day 0) and endpoint (week 8)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Gut Transit Time
Lasso di tempo: Baseline (day 0) and endpoint (week 8)
Evaluate changes in gut transit time after almond butter or control snack consumption from baseline to final analysis, using a blue-dye capsule.
Baseline (day 0) and endpoint (week 8)
Change in Waist/Hip Circumference
Lasso di tempo: Baseline (week 0), midpoint (week 4), and endpoint (week 8)
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.
Baseline (week 0), midpoint (week 4), and endpoint (week 8)
Change in Habitual Dietary Intake
Lasso di tempo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Assess changes in habitual dietary intake via 3-day food logs, analyzed using nutrient analysis software (NDSR).
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Body Weight
Lasso di tempo: Baseline (day 0), midpoint (week 4), endpoint (week 8)
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.
Baseline (day 0), midpoint (week 4), endpoint (week 8)
Change in Urinary Melatonin
Lasso di tempo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Changes in melatonin (urine metabolite 6-sulphatoxymelatonin) will be assessed before, during and after 8-week consumption of almond butter or control snack spread.
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Body Fat Percentage
Lasso di tempo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Evaluate changes in body composition, including fat mass, expressed as a percentage of total weight (%). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during almond butter or control snack consumption.
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Lipid Profiles
Lasso di tempo: Baseline (day 0) and endpoint (week 8)
Relevant biomarkers are to be collected via venous blood samples to determine changes in cardiometabolic health including HDL, LDL, total cholesterol, and triglycerides. All will be expressed in units of mg/dL.
Baseline (day 0) and endpoint (week 8)
Change in Biomarkers of Inflammation
Lasso di tempo: Baseline (day 0) and endpoint (week 8)
Relevant biomarkers are to be collected via venous blood samples to determine changes in inflammation, including but not limited to C-reactive protein (CRP), IL-1 (Interleukin-1), IL-1 beta, IL-6, IL-10, IL-17, IL-23, Tumor Necrosis Factor Alpha (TNF-a), Interferon-gamma (IFN-Y). All will be expressed in units of pg/mL.
Baseline (day 0) and endpoint (week 8)
Change in Biomarkers of Intestinal Barrier Function
Lasso di tempo: Baseline (day 0) and endpoint (week 8)
Relevant biomarkers are to be collected via venous blood samples to determine changes in intestinal barrier function including LPS (lipopolysaccharides), LBP (lipopolysaccharide binding protein), CD14, Secretory IgA. All will be expressed in units of pg/mL.
Baseline (day 0) and endpoint (week 8)
Change in Lean Mass
Lasso di tempo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Evaluate changes in body composition, including lean mass (kg). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during almond butter or control snack consumption.
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Biomarkers of Appetite
Lasso di tempo: Baseline (day 0) and endpoint (week 8)
Relevant biomarkers are to be collected via venous blood samples to determine changes in appetite including Insulin, Glucagon, glucagon-like peptide 1 (GLP-1), Adiponectin, Leptin, Ghrelin, and Peptide YY. All will be expressed in units of pg/mL.
Baseline (day 0) and endpoint (week 8)
Change in Rested, Seated Blood Pressure
Lasso di tempo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
This outcome measure will measure changes in blood pressure taken at rest in the seated position at each visit, before during and after almond butter or control snack consumption, expressed as systolic over diastolic blood pressure in units of millimeters of mercury (mmHg).
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Fasting Blood glucose
Lasso di tempo: Baseline (day 0) and endpoint (week 8)
Venous blood samples will be collected to determine changes in fasting blood glucose (expressed as mg/DL).
Baseline (day 0) and endpoint (week 8)
Dietary Adherence
Lasso di tempo: Daily, baseline (day 0) through endpoint (week 8)
Assess adherence to the intervention and control snack throughout the study, as determined by dietary adherence logs kept by the participants each week. Adherence is expressed as a daily percent (%) consumption of their assigned snack
Daily, baseline (day 0) through endpoint (week 8)
Change in Total Body Water
Lasso di tempo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Evaluate changes in body composition, including, total body water (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during almond butter or control snack consumption.
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Intracellular Fluid
Lasso di tempo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Evaluate changes in body composition, including intracellular fluid (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during almond butter or control snack consumption.
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Extracellular Fluid
Lasso di tempo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Evaluate changes in body composition, including extracellular fluid (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during almond butter or control snack consumption.
Baseline (day 0), midpoint (week 4), and endpoint (week 8)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Florida State University

Collaboratori

Almond Board of California

Investigatori

  • Investigatore principale: Ravinder Nagpal, PhD, Florida State University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

31 ottobre 2028

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 settembre 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00007355

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Deidentified IPD will not be retain past three years, at the time of this submission the researchers does not plan to make IPD available

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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