[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586558":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":79,"collaborators":82,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":25,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":25,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":51,"whyStopped":25,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Florida State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Peanut Butter Condition","EXPERIMENTAL","Peanut Butter (PB) Group: This condition involves a normal diet supplemented daily with a personalized portion of smooth peanut butter (Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter) sandwiched between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers). There is a limit of 16g of peanut butter per two crackers. The quantity of peanut butter 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.",[13],"Other: Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter",{"label":15,"type":16,"description":17,"interventionNames":18},"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",[19],"Other: Cadbury Milk Chocolate Spread",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter","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",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Cadbury Milk Chocolate Spread","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.",[15],[31,32,33],"Control Snack","CTL","Isocaloric Spread",[35],{"name":36,"affiliation":5,"role":37},"Ravinder Nagpal, Ph.D.","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":25,"email":43},"Cole Patoine, MS, RDN","CONTACT","850-644-1828","cjp23a@fsu.edu",{"name":45,"role":41,"phone":46,"phoneExt":25,"email":47},"FSU College of Education, Health and Human Services","850-644-1829","healthandhumansciences@fsu.edu",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Florida State Univresity - The Gut Biome Lab","RECRUITING","Tallahassee","Florida","32306","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-84.28073,30.43826,{"lat":61,"lon":60},[64,67,68,69,71,73,75,77],{"name":65,"role":41,"phone":46,"phoneExt":25,"email":66},"Ravinder Nagpal, PhD","rnagpal@fsu.edu",{"name":40,"role":41,"phone":25,"phoneExt":25,"email":43},{"name":65,"role":37,"phone":25,"phoneExt":25,"email":25},{"name":40,"role":70,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"name":72,"role":70,"phone":25,"phoneExt":25,"email":25},"Saiful Singar, MS",{"name":74,"role":70,"phone":25,"phoneExt":25,"email":25},"Andrea Lobene, PhD, RDN",{"name":76,"role":70,"phone":25,"phoneExt":25,"email":25},"Sadio Fenner, MS",{"name":78,"role":70,"phone":25,"phoneExt":25,"email":25},"Lily Houser",{"type":37,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Ravi Nagpal","Principal Investigator",[83],{"name":84,"class":6},"The Peanut Institute","100586558","effect-of-peanut-butter-on-gut-and-metabolic-health-100586558",false,"NCT06916936","Effect of Peanut Butter on Gut and Metabolic Health","Effect of Peanut Butter on Gut and Metabolic Health in School-Aged Children","Inclusion Criteria:\n\n* Enrolled in elementary or middle school (grades 1-8)\n* Aged 6-13 years old\n* Ability to speak and read in English\n\nExclusion Criteria:\n\n* Intake of antibiotics in the last 3 months\n* Intake of pre\u002Fpro\u002Fpostbiotics in the last 3 months\n* Food allergy to study foods\n\n  * Any allergy to nuts or peanuts\n* Any allergy to the isocaloric snack (chocolate or wheat)\n* Regular consumption of nuts or peanuts greater than 2 servings \u002F week\n* 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%).\n* Known to be pregnant (self-disclosed)",true,"ALL","6 Years","13 Years",{"count":97,"type":98},60,"ESTIMATED","INTERVENTIONAL",[101],"NA","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:\n\nPrimary Objective: To determine the prebiotic effect of daily smooth peanut butter consumption for eight weeks on gut health, including microbiome-metabolome arrays, gut epithelial\u002Fbarrier function, and gut transit time, in school-aged children.\n\nSecondary Objective(s)\n\n1. 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.\n2. To determine the potential mechanisms and feasibility of incorporating peanut butter into the diets of school-aged children as part of healthy, personalized nutrition.\n\nResearch 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:\n\n1. The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers.\n2. 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.",[104],"Dysbiosis",[106,107,108,109,110,111,112,113,114,115],"microbiome","gut","nuts","peanut butter","metabolic health","dysbiosis","metagenomic","sleep quality","prebiotic","children","2026-04-08",{"date":118,"type":119},"2026-04-09","ACTUAL",{"date":121,"type":119},"2025-02-09",{"date":123,"type":98},"2027-05",{"name":5,"class":6},1]