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Almonds, Gut Microbiome and Kids

11. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

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

Studiesteder

  • Forenede Stater
    • Florida
      • Tallahassee, Florida, Forenede Stater, 32306
        • Rekruttering
        • The Gut Biome Lab
        • Kontakt:
        • Underforsker:
          • Cole Patoine, MS, RD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Beskrivelse

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%).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Kontrol snack -tilstand
Control (CTL) -gruppe: Denne tilstand inkluderer en normal diæt suppleret dagligt med en isocalorisk mængde af en nødfri, vegetabilsk oliebaseret chokoladespredning (Cadbury-mælkechokolade), også klemt mellem to almindelige usaltede saltkrakkere (usaltede tops premium saltindikere), med den samme 16G-grænse pr. To krakere. Mængden af ​​chokoladespredning, der leveres dagligt, svarer til 20% af hver deltagers individuelle daglige kaloriindtag. Disse kaloriske behov vil blive etableret ved hjælp af diætretningslinjer for amerikanere (DGA) baseret på deltagerens alder og køn
Andet: Cadbury Milk Chocolate Spredning
Control (CTL) -gruppe: Deltagere i denne gruppe vil modtage en daglig snack bestående af en isocalorisk mængde af en nødfri, vegetabilsk oliebaseret chokoladespredning ("Cadbury mælkechokolade") spredt mellem to almindelige usaltede saltkiks ("Unsalted Tops Premium Saltine Crackers"). I lighed med Peanut Butter -gruppen vil chokoladespredningen være begrænset til 16g pr. To kiks, med yderligere kiks, der er leveret, hvis det er nødvendigt.
Andre navne:
  • Styring
  • CTL
  • Isocaloric spread
Eksperimentel: 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.
Andet: 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.
Andre navne:
  • ALB
  • Almond Butter

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Gut Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Fecal Samples
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Gut Transit Time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Florida State University

Samarbejdspartnere

Almond Board of California

Efterforskere

  • Ledende efterforsker: Ravinder Nagpal, PhD, Florida State University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

31. oktober 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00007355

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

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