[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659536":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":65,"studyPopulation":65,"armGroups":73,"interventions":91,"overallOfficials":65,"centralContacts":103,"locations":65,"responsibleParty":109,"collaborators":113,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":65,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":65,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":146,"whyStopped":65,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":65},{"fullName":5,"class":6},"George Mason University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":58},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Change in Subjective Sleep Disturbance","Change in subjective sleep outcomes assessed using the PROMIS Sleep Disturbance and PROMIS Sleep-Related Impairment questionnaires.","Baseline, Week 6, and Week 12",{"measure":14,"description":15,"timeFrame":12},"Change in Objective Sleep Measures","Change in objective sleep measures assessed using wrist-worn actigraphy.",{"measure":17,"description":18,"timeFrame":12},"Change in Anxiety Symptoms","Change in anxiety symptoms assessed using the PROMIS Emotional Distress-Anxiety questionnaire.",{"measure":20,"description":21,"timeFrame":12},"Change in Depressive Symptoms","Change in depressive symptoms assessed using the PROMIS Emotional Distress-Depression questionnaire.",{"measure":23,"description":24,"timeFrame":12},"Change in Fatigue","Change in fatigue assessed using the PROMIS Fatigue questionnaire.",[26,30,33,36,39,42,45,48,51,54],{"measure":27,"description":28,"timeFrame":29},"Change in Glycemic Control","Glycemic control will be assessed using fasting glucose concentration (mg\u002FdL) measured from fasting blood samples","Baseline, Week 6, and Week 12.",{"measure":31,"description":32,"timeFrame":29},"Change in Insulin Sensitivity\u002FResistance","Fasting glucose concentration (mg\u002FdL) and fasting insulin concentration (µU\u002FmL) will be measured from fasting blood samples and used to calculate insulin sensitivity\u002Fresistance indices, including HOMA-IR, QUICKI, and SPISE. HOMA-IR, QUICKI, and SPISE are calculated indices and are reported as unitless values. Changes from baseline to Week 12 will be compared across study groups.",{"measure":34,"description":35,"timeFrame":29},"Change in Continuous Glucose Monitoring Measures","Assessed using CGM-derived glucose metrics.",{"measure":37,"description":38,"timeFrame":29},"Change in Lipid Profile","Assessed using fasting lipid measurements.",{"measure":40,"description":41,"timeFrame":29},"Change in Inflammation","Assessed using high-sensitivity C-reactive protein (hs-CRP).",{"measure":43,"description":44,"timeFrame":29},"Change in Liver Enzymes","Assessed using ALT and AST.",{"measure":46,"description":47,"timeFrame":29},"Change in Blood Pressure","Assessed using resting systolic and diastolic blood pressure.",{"measure":49,"description":50,"timeFrame":29},"Change in Anthropometric Measures and Body Composition","Assessed using body weight, BMI, and body composition measurements.",{"measure":52,"description":53,"timeFrame":29},"Change in Dietary Intake","Assessed using dietary intake records.",{"measure":55,"description":56,"timeFrame":57},"Change in Long-Term Glycemic Control","HbA1c (%) measured by finger-stick blood collection. Changes from baseline to Week 12 will be compared across study groups.","Baseline, Week 12",[59],{"measure":60,"description":61,"timeFrame":29},"Change in Physical Activity","Assessed using physical activity questionnaires.",{"allocation":63,"interventionModel":64,"interventionModelDescription":65,"primaryPurpose":66,"observationalModel":65,"timePerspective":65,"maskingInfo":67},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":68,"maskingDescription":65,"whoMasked":69},"TRIPLE",[70,71,72],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR",[74,80,85],{"label":75,"type":76,"description":77,"interventionNames":78},"Low-Dose Whole-Food-Based Magnesium Supplement","EXPERIMENTAL","Participants will receive E-Z Mg™, providing 70 mg elemental magnesium per day, for 12 weeks. Participants will also receive standardized nutrition education.",[79],"Dietary Supplement: Low-Dose Whole-Food-Based Magnesium Supplement",{"label":81,"type":76,"description":82,"interventionNames":83},"Moderate-Dose Whole-Food-Based Magnesium Supplement Placebo","Participants will receive E-Z Mg™, providing 140 mg elemental magnesium per day, for 12 weeks. Participants will also receive standardized nutrition education.",[84],"Dietary Supplement: Moderate-Dose Whole-Food-Based Magnesium Supplement",{"label":86,"type":87,"description":88,"interventionNames":89},"Placebo","PLACEBO_COMPARATOR","Participants will receive a placebo containing no magnesium for 12 weeks. Participants will also receive standardized nutrition education.",[90],"Other: Placebo",[92,96,100],{"type":93,"name":75,"description":94,"armGroupLabels":95,"otherNames":65},"DIETARY_SUPPLEMENT","Participants assigned to an active intervention arm will receive either 70 mg of elemental magnesium daily for 12 weeks, according to randomized group assignment.",[75],{"type":93,"name":97,"description":98,"armGroupLabels":99,"otherNames":65},"Moderate-Dose Whole-Food-Based Magnesium Supplement","Participants assigned to an active intervention arm will receive either 140 mg of elemental magnesium daily for 12 weeks, according to randomized group assignment.",[81],{"type":6,"name":86,"description":101,"armGroupLabels":102,"otherNames":65},"The placebo contains no magnesium and is prepared by the same company as whole food based magnesium. Participants assigned to the placebo arm will take the placebo daily for 12 weeks. The placebo will be provided in identical-looking coded containers to maintain study blinding.",[86],[104],{"name":105,"role":106,"phone":107,"phoneExt":65,"email":108},"Raedeh Basiri, PhD,RDN","CONTACT","7039936575","rbasiri@gmu.edu",{"type":110,"investigatorFullName":111,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":65,"oldOrganization":65},"PRINCIPAL_INVESTIGATOR","Raedeh Basiri","Assistant Professor",[114],{"name":115,"class":116},"Standard Process Inc.","INDUSTRY","100659536","whole-food-magnesium-for-mental-and-cardiometabolic-health-100659536",false,"NCT07865351","Whole-Food Magnesium for Mental and Cardiometabolic Health","Effects of Organic Whole-Food Magnesium (E-Z MgTM) on Mood, Fatigue, Sleep, and Cardiometabolic Outcomes in Adults With Elevated Blood Glucose","Inclusion Criteria:\n\n* Age 40-70 years\n* BMI 18.5-29.9 kg\u002Fm²\n* HbA1c 5.7%-6.4%\n* Stable medication regimen for at least 3 months\n* Individuals taking a stable dose of metformin may be included\n\nExclusion Criteria:\n\n* Severe psychiatric or sleep disorders\n* Diagnosed diabetes\n* Pregnancy or breastfeeding\n* Clinically significant thyroid, kidney, liver, or pancreatic disease\n* Active cancer\n* Known iron overload\n* History of bariatric surgery\n* Heavy smoking\n* Heavy alcohol use\n* Uncontrolled hypertension\n* Current supplement use that may interact with study outcomes\n* Current participation in an active weight-loss program or use of weight-loss medications\n* Current participation in another clinical trial","ALL","40 Years","70 Years",{"count":128,"type":129},45,"ESTIMATED","INTERVENTIONAL",[132],"NA","This randomized, double-blind, placebo-controlled clinical trial will evaluate the effects of daily supplementation with E-Z Mg™, a commercially available whole-food-based magnesium supplement, on sleep, mood, fatigue, and cardiometabolic health in adults with elevated blood glucose. The study will enroll 45 adults aged 40-70 years with HbA1c 5.7%-6.4% and BMI 18.5-29.9 kg\u002Fm². Participants will be randomized to receive low-dose E-Z Mg™ providing 70 mg elemental magnesium per day, moderate-dose E-Z Mg™ providing 140 mg elemental magnesium per day, or placebo containing no magnesium for 12 weeks. All participants will also receive standardized nutrition education.\n\nThe primary outcomes are changes in subjective and objective sleep quality, mood, and fatigue. These outcomes will be assessed using PROMIS questionnaires and actigraphy. Secondary outcomes include glycemic control, insulin sensitivity, continuous glucose monitoring-derived glucose measures, lipid profile, liver enzymes, inflammatory markers, blood pressure, anthropometric measures, body composition, dietary intake, and physical activity.\n\nStudy assessments will occur at baseline, Week 6, and Week 12 and will include fasting blood samples, HbA1c testing (baseline and end of the stuy), continuous glucose monitoring, actigraphy, blood pressure, anthropometric and body composition measurements, dietary and physical activity assessments, demographics and medical and medication history questionnaires, adherence monitoring, and adverse-event monitoring.\n\nThis study is designed to determine whether whole-food-based magnesium supplementation, and whether different doses of E-Z Mg™, may improve sleep, mood, fatigue, and cardiometabolic outcomes in adults with elevated blood glucose.",[135],"Elevated Blood Glucose",[137,138,139,140,141,142,143,144,145],"Magnesium","E-Z Mg","Sleep","Mood","Fatigue","Glycemic Control","Insulin Sensitivity","CGM","Cardiometabolic Health","NOT_YET_RECRUITING","2026-10-05",{"date":149,"type":150},"2026-10-08","ACTUAL",{"date":152,"type":129},"2026-11",{"date":154,"type":129},"2027-11",{"name":5,"class":6}]