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Almonds, Gut Microbiome and Kids

11. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

70

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Rayven Nairn, MS, RD
  • Telefonnummer: 850-644-1829
  • E-Mail: rsn25b@fsu.edu

Studienorte

  • Vereinigte Staaten
    • Florida
      • Tallahassee, Florida, Vereinigte Staaten, 32306
        • Rekrutierung
        • The Gut Biome Lab
        • Kontakt:
        • Unterermittler:
          • Cole Patoine, MS, RD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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%).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Snack -Zustand steuern
Kontrollgruppe (CONTL): Dieser Zustand umfasst eine normale Diät, die täglich mit einer isokalorischen Menge einer nussfreien, schokoladenen Spread (Cadbury Milk Chocolate) mit nussfreiem Gemüseöl-Basis (Cadbury Milk Chocolate) zwischen zwei einfachen nicht gesalzenen Salzcrackern (ungesalzene Tops Premium-Salzin-Cracker) mit dem gleichen 16G-Grenzwert pro zwei Cracks liegt. Die tägliche Menge an Schokoladenverbreitung entspricht 20% der täglichen Kalorienaufnahme jedes Teilnehmers. Diese kalorischen Bedürfnisse werden unter Verwendung von Ernährungsrichtlinien für Amerikaner (DGA) auf der Grundlage des Alters und des Geschlechts des Teilnehmers festgelegt
Sonstiges: Cadbury Milchschokolade Ausstrahlung
Control (CTL) -Gruppe: Die Teilnehmer dieser Gruppe erhalten einen täglichen Snack, der aus einer isokalorischen Menge einer nussfreien Schokoladenverteilung auf Gemüseöl ("Cadbury Milk Chocolate") besteht, die zwischen zwei einfachen, nicht geaderten Salzcrackern ("ungesalte Tops Premium-Salzincracker") verteilt ist. Ähnlich wie bei der Erdnussbuttergruppe wird die Schokoladenverbreitung auf 16 g pro zwei Cracker begrenzt, wobei bei Bedarf zusätzliche Cracker bereitgestellt werden.
Andere Namen:
  • Kontrolle
  • CTL
  • Isocaloric spread
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.
Sonstiges: 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.
Andere Namen:
  • ALB
  • Almond Butter

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Gut Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Fecal Samples
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Gut Transit Time
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Florida State University

Mitarbeiter

Almond Board of California

Ermittler

  • Hauptermittler: Ravinder Nagpal, PhD, Florida State University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

31. Oktober 2028

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

1. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juni 2026

Zuerst gepostet (Tatsächlich)

9. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. September 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY00007355

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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