Almonds, Gut Microbiome and Kids
11 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
70
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: FSU College of Education, Health and Human Services
- Número de telefone: 850-644-1829
- E-mail: healthandhumansciences@fsu.edu
Estude backup de contato
- Nome: Rayven Nairn, MS, RD
- Número de telefone: 850-644-1829
- E-mail: rsn25b@fsu.edu
Locais de estudo
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Florida
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Tallahassee, Florida, Estados Unidos, 32306
- Recrutamento
- The Gut Biome Lab
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Contato:
- Ravinder Nagpal, PhD
- Número de telefone: 850-644-1829
- E-mail: rnagpal@fsu.edu
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Subinvestigador:
- Cole Patoine, MS, RD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Sim
Descrição
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%).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Controle condição de lanche
Grupo de controle (CTL): Esta condição inclui uma dieta normal suplementada diariamente com uma quantidade isocalórica de uma propagação de chocolate à base de vegetais e sem nozes (chocolate ao leite de Cadbury) também passa entre dois biscoitos salgados sem sal (biscoitos salgados sem sal (tampes não salados premium), com o mesmo limite de 16g por dois biscoitos.
A quantidade de propagação de chocolate fornecida diariamente será equivalente a 20% da ingestão calórica diária individual de cada participante.
Essas necessidades calóricas serão estabelecidas usando diretrizes alimentares para os americanos (DGA) com base na idade e sexo do participante
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Grupo de Controle (CTL): Os participantes deste grupo receberão um lanche diário que consiste em uma quantidade isocalórica de uma propagação de chocolate à base de óleo vegetal sem nozes ("Chocolate com leite de Cadbury") se espalhou entre dois biscoitos salgados não salgados ("Crackers salgadas salgadas não salmas").
Semelhante ao grupo de manteiga de amendoim, o spread de chocolate será limitado a 16g por dois biscoitos, com biscoitos adicionais, se necessário.
Outros nomes:
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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.
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Gut Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Fecal Samples
Prazo: Baseline (day 0), midpoint (week 4) and endpoint (week 8)
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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.
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Baseline (day 0), midpoint (week 4) and endpoint (week 8)
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Change in Oral Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Oral Swabs
Prazo: Baseline (day 0) and Endpoint (week 8)
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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.
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Baseline (day 0) and Endpoint (week 8)
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Change in Fecal Metabolome
Prazo: Baseline (day 0) and endpoint (week 8)
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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.
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Baseline (day 0) and endpoint (week 8)
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Change in Serum Metabolome
Prazo: Baseline (day 0) and endpoint (week 8)
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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.
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Baseline (day 0) and endpoint (week 8)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Gut Transit Time
Prazo: Baseline (day 0) and endpoint (week 8)
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Evaluate changes in gut transit time after almond butter or control snack consumption from baseline to final analysis, using a blue-dye capsule.
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Baseline (day 0) and endpoint (week 8)
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Change in Waist/Hip Circumference
Prazo: Baseline (week 0), midpoint (week 4), and endpoint (week 8)
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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.
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Baseline (week 0), midpoint (week 4), and endpoint (week 8)
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Change in Habitual Dietary Intake
Prazo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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Assess changes in habitual dietary intake via 3-day food logs, analyzed using nutrient analysis software (NDSR).
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Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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Change in Body Weight
Prazo: Baseline (day 0), midpoint (week 4), endpoint (week 8)
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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.
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Baseline (day 0), midpoint (week 4), endpoint (week 8)
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Change in Urinary Melatonin
Prazo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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Changes in melatonin (urine metabolite 6-sulphatoxymelatonin) will be assessed before, during and after 8-week consumption of almond butter or control snack spread.
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Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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Change in Body Fat Percentage
Prazo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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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.
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Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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Change in Lipid Profiles
Prazo: Baseline (day 0) and endpoint (week 8)
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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.
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Baseline (day 0) and endpoint (week 8)
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Change in Biomarkers of Inflammation
Prazo: Baseline (day 0) and endpoint (week 8)
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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.
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Baseline (day 0) and endpoint (week 8)
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Change in Biomarkers of Intestinal Barrier Function
Prazo: Baseline (day 0) and endpoint (week 8)
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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.
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Baseline (day 0) and endpoint (week 8)
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Change in Lean Mass
Prazo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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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.
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Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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Change in Biomarkers of Appetite
Prazo: Baseline (day 0) and endpoint (week 8)
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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.
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Baseline (day 0) and endpoint (week 8)
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Change in Rested, Seated Blood Pressure
Prazo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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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).
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Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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Change in Fasting Blood glucose
Prazo: Baseline (day 0) and endpoint (week 8)
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Venous blood samples will be collected to determine changes in fasting blood glucose (expressed as mg/DL).
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Baseline (day 0) and endpoint (week 8)
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Dietary Adherence
Prazo: Daily, baseline (day 0) through endpoint (week 8)
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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
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Daily, baseline (day 0) through endpoint (week 8)
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Change in Total Body Water
Prazo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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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.
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Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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Change in Intracellular Fluid
Prazo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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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.
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Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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Change in Extracellular Fluid
Prazo: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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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.
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Baseline (day 0), midpoint (week 4), and endpoint (week 8)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ravinder Nagpal, PhD, Florida State University
Publicações e links úteis
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de outubro de 2026
Conclusão Primária (Estimado)
31 de outubro de 2028
Conclusão do estudo (Estimado)
31 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
1 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de junho de 2026
Primeira postagem (Real)
9 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de setembro de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00007355
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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