[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465161":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":59,"collaborators":28,"id":61,"slug":28,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":28,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":28,"enrollmentInfo":69,"targetDuration":28,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":28,"overallStatus":45,"whyStopped":28,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Virginia Polytechnic Institute and State University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Aspartame","ACTIVE_COMPARATOR","Controlled feeding study. Dosage of aspartame will follow 25% of the acceptable daily intake (equivalent to 12.5 mg\u002Fkg for aspartame). This amount represents 750 mg\u002Fday of aspartame for a 60 kg adult.",[13],"Other: Non-Nutritive Sweetener Intake and impact on glucose homeostasis",{"label":15,"type":10,"description":16,"interventionNames":17},"Sucralose","Controlled feeding study. Dosage of sucralose will follow 25% of the acceptable daily intake (equivalent to 1.25 mg\u002Fkg for sucralose). This amount represents 75 mg\u002Fday of sucralose for a 60 kg adult.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"No NNS","SHAM_COMPARATOR","Controlled feeding study with no non-nutritive sweeteners.",[13],[24],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Non-Nutritive Sweetener Intake and impact on glucose homeostasis","Provision of either aspartame, sucralose, or control with no non-nutritive sweeteners to a controlled feeding study to determine impacts on glucose homeostasis.",[9,19,15],null,[30],{"name":31,"affiliation":5,"role":32},"Valisa Hedrick, PhD","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":37},"CONTACT","540-231-7983","vhedrick@vt.edu",{"name":39,"role":35,"phone":40,"phoneExt":28,"email":41},"Elaina Marinik, PhD","540-231-0923","emarinik@vt.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Virginia Tech","RECRUITING","Blacksburg","Virginia","24061","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-80.41394,37.22957,{"lat":55,"lon":54},[58],{"name":31,"role":35,"phone":28,"phoneExt":28,"email":28},{"type":60,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100465161",false,"NCT05337098","Non-Nutritive Sweetener Consumption and Glucose Homeostasis in Older Adults With Prediabetes","Non-Nutritive Sweetener Consumption (Aspartame and Sucralose) and Glucose Homeostasis in Older Adults With Prediabetes","Inclusion Criteria:\n\n* Age 40+ years\n* Prediabetic (fasting glucose concentration of 100-125 mg\u002FdL, 2-hour oral glucose tolerance test glucose concentration of 140-199 mg\u002FdL, or a HbA1c value of 5.7% to 6.4%)\n* Weight stable for previous 6 months (±2 kg)\n* BMI \\\u003C40 kg\u002Fm2\n* Sedentary to recreationally active\n* No plans to gain\u002Flose weight or change physical activity level\n* Willing to pick up food daily and consume foods provided for an 8-week period\n* Verbal and written informed consent\n* Approval by Medical Director\n* Consume less than one serving of non-nutritive sweetener per week\n\nExclusion Criteria:\n\n* BMI \\>40 kg\u002Fm2\n* Diabetes or diabetes medication\n* Antibiotic, prebiotic or prebiotic use in prior 3 months\n* Uncontrolled hypertension (blood pressure (BP) \\> 159\u002F99 mmHg)\n* Diagnosed inflammatory bowel disease\n* Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease\n* Vegetarian or vegan\n* Pregnant or plans to become pregnant\n* Breastfeeding\n* Food allergies or aversions, Phenylketonuria (PKU)\n* Estrogen or testosterone usage","ALL","40 Years",{"count":70,"type":71},30,"ESTIMATED","INTERVENTIONAL",[74],"NA","Animal and observational research in humans suggest that specific types of non-nutritive sweeteners (NNS) may impair glycemic control. However, whether NNS consumption impacts glucose homeostasis in middle-aged\u002Folder adults with prediabetes is unknown, and potential mechanisms by which this could occur have yet to be identified. The overall objective of this R21 proposal is to establish proof-of-concept for alterations in glucose homeostasis following intake of sucralose, but not aspartame, in middle-aged\u002Folder adults with prediabetes compared to a eucaloric diet with no NNS.",[77,78,79,80],"Continuous Glucose Monitoring","Oral Glucose Tolerance","Insulin Sensitivity","Inflammatory Markers","2025-12-03",{"date":83,"type":84},"2025-12-04","ACTUAL",{"date":86,"type":84},"2023-04-18",{"date":88,"type":71},"2026-02-28",{"name":5,"class":6},1]