[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647685":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":25,"responsibleParty":43,"collaborators":25,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":25,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":25,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":70,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":25},{"fullName":5,"class":6},"Standard Process Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","No chromium ingredients",[13],"Dietary Supplement: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Diaplex","ACTIVE_COMPARATOR","Chromium ingredients",[19],"Dietary Supplement: Diaplex",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Standard Process Diaplex product",[15],null,{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo with no chormium ingredients",[9],[30],{"name":31,"affiliation":32,"role":33},"Shirin Pourafshar, PhD","Clinical Study Manager","STUDY_DIRECTOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Chinmayee Panda, PhD","CONTACT","262-495-6410","cpanda@standardprocess.com",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},"Brea Nance","bnance@standardprocess.com",{"type":44,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100647685","diaplex-and-glycemic-control-100647685",false,"NCT07711587","Diaplex and Glycemic Control","A Pilot Study Investigating the Effects of Diaplex Supplementation on Glucose Regulation in Otherwise Healthy Adults With Elevated Blood Glucose Levels","Inclusion Criteria • Adults 30-65 years old with elevated average blood glucose levels (100-125 mg\u002FdL), confirmed at screening (HbA1c 5.7-6.4%)\n\n• BMI 18.5-29.9 kg\u002Fm² (normal to overweight)\n\n• Generally healthy individuals with no metabolic or endocrine disorders besides elevated blood glucose levels, meaning no metabolic syndrome, insulin resistance diagnosis, dyslipidemia diagnosis requiring treatment, thyroid disorders, etc.\n\n• Stable weight for the past 3 months (±5%)\n\n• Sedentary or lightly active baseline lifestyle (Light activity ≤3 times\u002Fweek (e.g., walking, yoga, casual biking)\n\n• Willingness to maintain usual diet, activity, and sleep patterns for 16 weeks\n\n• Able and willing to wear a CGM for the final 10-14 days\n\n• Willing to complete 3-day dietary recalls, sleep and activity logs\n\n• Not taking or willing to stop taking supplements containing chromium, vitamin A, vitamin B6, iodine, and niacin\n\n• Able and willing to provide informed consent and complete all study visits 6 Exclusion Criteria\n\n• Any diagnosed metabolic\u002Fendocrine disorder, other than elevated blood glucose levels, such as metabolic syndrome, insulin resistance diagnosis, clinically significant dyslipidemia, thyroid dysfunction or use of thyroid medication, or obesity-related endocrine dysfunction\n\n• Medications and supplements use of glucose-lowering medications within the past 3 months, including use of weight-loss drugs or metabolic agents, such asGLP-1 RAs (Ozempic, Wegovy, Rybelsus, Trulicity, Victoza, Saxenda) or GIP\u002FGLP-1 RAas (Mounjaro, Zepbound)\n\n• Use of supplements within the last 30 days containing chromium, vitamin A, vitamin B6, niacin, iodine\n\n• Unwilling to discontinue prohibited supplements\n\n• Health Conditions \\& safety such as elevated ALT\u002FAST more than 2× the upper limit or known chronic liver disease or diagnosed renal impairment (eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m²), uncontrolled hypertension (\\>160\u002F100 mmHg)\n\n• Pregnant, breastfeeding, or planning pregnancy\n\n• Allergy or sensitivity to study ingredients or CGM adhesives\n\n• Lifestyle and compliance (\\>30 minutes\u002Fday of intense physical activity (active adults or athletes))\n\n• Participation in another investigational trial in the past 30 days\n\n• Any condition that may interfere with participation or data quality (per investigator guidance)",true,"ALL","30 Years","65 Years",{"count":57,"type":58},40,"ESTIMATED","INTERVENTIONAL",[61],"NA","The goal of this 16-week double-blind, placebo-controlled pilot study is to determine whether daily Diaplex supplementation improves insulin sensitivity and glycemic control in adults with elevated blood glucose levels, while generating high-quality preliminary data on metabolic effects, glycemic patterns, and safety to inform future trials",[64,65],"Insulin Sensitivity","Healthy Adult",[67,68,69],"Supplement","Chromium","Glycemic Index","NOT_YET_RECRUITING","2026-07-13",{"date":73,"type":74},"2026-07-17","ACTUAL",{"date":76,"type":58},"2026-09-01",{"date":78,"type":58},"2027-12-15",{"name":5,"class":6}]