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| Name | Class |
|---|---|
| Almond Board of California | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almond Butter Condition | Experimental | 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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| Control Snack Condition | Active Comparator | Control (CTL) Group: This condition includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread (Cadbury Milk Chocolate) also sandwiched between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers), with the same 16g limit per two crackers. The quantity of chocolate spread provided daily will be equivalent to 20% of each participant's individual daily caloric intake. These caloric needs will be established using Dietary Guidelines for Americans (DGA) based on the participant's age and gender |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Creamy Richards 100% Almonds! Creamy Natural Almond Butter | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gut Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Fecal Samples | 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 | 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 | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gut Transit Time | 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 |
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Inclusion Criteria:
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
â—¦ 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%).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rayven Nairn, MS, RD | Contact | 850-644-1829 | rsn25b@fsu.edu | |
| FSU College of Education, Health and Human Services | Contact | 850-644-1829 | healthandhumansciences@fsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ravinder Nagpal, PhD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Gut Biome Lab | Recruiting | Tallahassee | Florida | 32306 | United States |
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| Label | URL |
|---|---|
| Lab Website | View source |
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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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| ID | Term |
|---|---|
| D064806 | Dysbiosis |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| Cadbury Milk Chocolate Spread | Other | Control (CTL) Group: Participants in this group will receive a daily snack consisting of an isocaloric amount of a nut-free, vegetable oil-based chocolate spread ("Cadbury Milk Chocolate") spread between two plain unsalted saltine crackers ("Unsalted Tops Premium Saltine Crackers"). Similar to the peanut butter group, the chocolate spread will be limited to 16g per two crackers, with additional crackers provided if needed. |
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| Baseline (day 0) 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |