NCT Number: NCT06916936
The goal of this is parallel arm, randomized clinical trial is to learn and understand the effect of daily smooth peanut butter consumption on gut and metabolic health of children age 6-13. The main objectives are:
Primary Objective: To determine the prebiotic effect of daily smooth peanut butter consumption for eight weeks on gut health, including microbiome-metabolome arrays, gut epithelial/barrier function, and gut transit time, in school-aged children.
Secondary Objective(s)
1. To determine the effect of daily smooth peanut butter consumption for eight weeks on metabolic and inflammatory health markers, and measures of sleep quality in school-aged children. 2. To determine the potential mechanisms and feasibility of incorporating peanut butter into the diets of school-aged children as part of healthy, personalized nutrition.
Research Intervention(s): Researchers compare two groups to see if there really is an effect of daily smooth peanut butter intake on gut and metabolic health. The two groups are:
1. The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers. 2. The 2nd condition (CTL) includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread, sandwiched between two plain unsalted saltine crackers.
Interested in participating?
Request Info6 year–13 year
All sexes
Interventional
Not applicable
Tallahassee, Florida, 32306, United States
Location status: Recruiting
Andrea Lobene, PhD, RDN
SUB_INVESTIGATOR
Cole Patoine, MS, RDN
CONTACT
Cole Patoine, MS, RDN
SUB_INVESTIGATOR
Lily Houser
SUB_INVESTIGATOR
Ravinder Nagpal, PhD
CONTACT
Ravinder Nagpal, PhD
PRINCIPAL_INVESTIGATOR
Sadio Fenner, MS
SUB_INVESTIGATOR
Saiful Singar, MS
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Peanut Butter (PB) Group: Participants in this group will receive a daily snack consisting of a personalized portion of smooth peanut butter ("Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter") spread between two plain unsalted saltine crackers ("Unsalted Tops Premium Saltine Crackers"). The amount of peanut butter will be limited to 16g per two crackers, but additional crackers will be provided if the personalized portion exceeds this limit
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.
Other names: Control Snack, CTL, Isocaloric Spread
Time frame: Baseline (day 0) Midpoint (week 4), and endpoint (week 8)
Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria.
Time frame: Baseline (day 0), Endpoint (week 8)
Oral swab samples are collected to determine oral diversity and composition of bacteria in the mouth before and after intervention.
Time frame: 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 peanut butter intake affects metabolic processes and gut health.
Time frame: 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 peanut butter intake affects metabolic processes and gut health.
Time frame: Baseline (day 0), and endpoint (week 8)
Evaluate changes in gut transit time after peanut butter or control snack consumption from baseline to final analysis, using a blue-dye capsule.
Time frame: baseline (day 0), midpoint (week 4), 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 peanut butter consumption, compared to a control snack.
Time frame: 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).
Time frame: 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 peanut butter or a control snack spread.
Time frame: Baseline (day 0) Midpoint (week 4), endpoint (week 8).
Changes in melatonin (urine metabolite 6-sulphatoxymelatonin) will be assessed before, during and after 8-week consumption of peanut butter or control snack spread.
Time frame: Baseline (day 0) Midpoint (week 4), endpoint (week 8).
Changes in urinary serotonin (urine metabolite 5-HIAA) will be assessed before, during and after 8-week consumption of peanut butter or control snack spread.
Time frame: Baseline (day 0), midpoint (week 4), 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 peanut butter or control snack consumption.
Time frame: Baseline (day 0), 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.
Time frame: Baseline (day 0), 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.
Time frame: Baseline (day 0), 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.
Time frame: Baseline (day 0), midpoint (week 4), 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 peanut butter or control snack consumption.
Time frame: baseline (day 0), 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.
Time frame: Baseline (day 0), midpoint (week 4), 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 peanut butter or control snack consumption, expressed as systolic over diastolic blood pressure in units of millimeters of mercury (mmHg).
Time frame: Baseline (day 0), endpoint (week 8).
Venous blood samples will be collected to determine changes in fasting blood glucose (expressed as mg/DL).
Time frame: Daily, baseline 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
Time frame: Baseline (day 0), midpoint (week 4), 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 peanut butter or control snack consumption.
Time frame: Baseline (day 0), midpoint (week 4), 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 peanut butter or control snack consumption.
Time frame: Baseline (day 0), midpoint (week 4), 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 peanut butter or control snack consumption.
Contact information is provided by the study sponsor or research team.
Cole Patoine, MS, RDN
CONTACT
FSU College of Education, Health and Human Services
CONTACT
Florida State University
Other
Effect of Peanut Butter on Gut and Metabolic Health in School-Aged Children
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