[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578184":3},{"organization":4,"outcomesModule":7,"designInfo":60,"detailedDescription":69,"studyPopulation":59,"armGroups":70,"interventions":83,"overallOfficials":59,"centralContacts":93,"locations":59,"responsibleParty":103,"collaborators":59,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":59,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":59,"enrollmentInfo":116,"targetDuration":59,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":59,"overallStatus":125,"whyStopped":59,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":59},{"fullName":5,"class":6},"Huazhong University of Science and Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":59},[9,13],{"measure":10,"description":11,"timeFrame":12},"Concentration of fasting blood glucose (FBG)","Concentration of FBG, measured in mmol\u002FL","0 week, 12th week, and 24th week in the intervention period",{"measure":14,"description":15,"timeFrame":12},"Glycated hemoglobin (HbA1c)","Concentration of HbA1c, measured in the percentage of hemoglobin",[17,20,23,26,29,32,35,38,41,44,47,50,53,56],{"measure":18,"description":19,"timeFrame":12},"Concentration of fasting plasma insulin (FPI)","Concentration of FPI, measured in μIU\u002FmL",{"measure":21,"description":22,"timeFrame":12},"Concentration of plasma c-peptide","Concentration of plasma c-peptide, measured in nmol\u002FL",{"measure":24,"description":25,"timeFrame":12},"Homeostatic model assessment of insulin resistance (HOMA-IR)","HOMA-IR can be calculated as (FPI \\[μU\u002FmL\\] × FBG \\[mmol\u002FL\\]) \u002F 22.5",{"measure":27,"description":28,"timeFrame":12},"Homeostatic model assessment of β-cell function (HOMA-β)","HOMA-β is calculated as (20 × FPI \\[μU\u002FmL\\]) \u002F (FBG \\[mmol\u002FL\\] - 0.195)",{"measure":30,"description":31,"timeFrame":12},"Homeostatic model assessment of insulin sensitivity (HOMA-S)","HOMA-S is calculated as 1 \u002F HOMA-IR",{"measure":33,"description":34,"timeFrame":12},"Concentration of blood lipids","Concentration of blood lipids: total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, measured in mmol\u002FL",{"measure":36,"description":37,"timeFrame":12},"Concentration of C-reactive protein (CRP)","Concentration of CRP, measured in mg\u002FdL",{"measure":39,"description":40,"timeFrame":12},"Concentration of interleukin-6 (IL-6)","Concentration of IL-6, measured in pg\u002FmL",{"measure":42,"description":43,"timeFrame":12},"Concentration of malondialdehyde (MDA)","Concentration of MDA, measured in μmol\u002FL",{"measure":45,"description":46,"timeFrame":12},"Activity of Cu-Zn superoxide dismutase (SOD)","Activity of Cu-Zn SOD, measured in U\u002FmL",{"measure":48,"description":49,"timeFrame":12},"Concentration of homocysteine (HCY)","Homocysteine (HCY) \\[μmol\u002FL\\]",{"measure":51,"description":52,"timeFrame":12},"Concentration of plasma albumin (ALB)","Concentration of ALB, measured in g\u002FdL",{"measure":54,"description":55,"timeFrame":12},"Concentration of plasma creatinine","Concentration of plasma creatinine, measured in μmol\u002FL",{"measure":57,"description":58,"timeFrame":12},"Concentration of plasma zinc","Concentration of plasma zinc concentrations, measured in mg\u002FdL",null,{"allocation":61,"interventionModel":62,"interventionModelDescription":59,"primaryPurpose":63,"observationalModel":59,"timePerspective":59,"maskingInfo":64},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":65,"maskingDescription":59,"whoMasked":66},"DOUBLE",[67,68],"PARTICIPANT","INVESTIGATOR","The goal of this randomized, double-blind, placebo-controlled study included patients with elevated glycemic status is to investigate whether zinc supplementation (4mg per day) has beneficial effects on controlling blood glucose.\n\nAbout 124 patients aged 18 years or older, had resided locally for at least one year, with elevated glycemic status will be enrolled in the study. Patients with elevated glycemic status are defined as meeting any of the following criteria:\n\n1. Fasting blood glucose ≥ 6.1 mmol\u002FL;\n2. Glycated hemoglobin (HbA1c) ≥ 5.7%;\n3. Oral glucose tolerance test (OGTT) 2-hour or postprandial blood glucose ≥ 7.8 mmol\u002FL;\n4. Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.\n\nEligible participants will be assigned by chance to one of two groups: (1) daily zinc supplementation: zinc-enriched yeast capsules (4 mg); (2) daily edible yeast placebo capsules (not zinc-enriched) (4mg). Randomization will be conducted.\n\nAt enrollment, baseline questionnaires are designed to collect data on sociodemographic factors, lifestyle habits, health status, and medical conditions. Participants in both groups will take one capsule that contained either Zinc-enriched yeast or edible yeast placebo each day until the end of the intervention period.\n\nParticipants will be followed up two times (3 months and 6 months post-intervention), and receive a single stage-specific dosage at any given follow-up time. During each follow-up visit, participants will complete a questionnaire survey, a 3-day 24-hour dietary recall, and undergo physical measurements. Blood, urine, and stool samples will also be obtained in the study center, fasting blood glucose, HbA1c and other biochemical indicators will also be detected at the same time.\n\nThe primary outcomes, including fasting blood glucose and HbA1c will be measured using blood samples. Secondary outcomes in this study include changes in blood lipids (such as total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol), trends in plasma zinc levels, inflammatory factors, oxidative stress indexes, other blood indicators and liver and kidney function indicators. Data will be collected and analyzed.",[71,77],{"label":72,"type":73,"description":74,"interventionNames":75},"Zinc supplementation","EXPERIMENTAL","zinc-enriched yeast capsule, 15mg\u002Fd",[76],"Dietary Supplement: Zinc-enriched yeast capsule",{"label":78,"type":79,"description":80,"interventionNames":81},"Edible yeast placebo","PLACEBO_COMPARATOR","Edible yeast placebo capsule, 15mg\u002Fd",[82],"Dietary Supplement: Edible yeast placebo capsule",[84,89],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":59},"DIETARY_SUPPLEMENT","Zinc-enriched yeast capsule","Daily zinc supplementation: zinc-enriched yeast capsules (15 mg) for a total of 6 months.",[72],{"type":85,"name":90,"description":91,"armGroupLabels":92,"otherNames":59},"Edible yeast placebo capsule","Daily edible yeast placebo capsules (not zinc-enriched) (15 mg) for a total of 6 months.",[78],[94,99],{"name":95,"role":96,"phone":97,"phoneExt":59,"email":98},"Zhilei Shan, PHD","CONTACT","15871720906","zhileishan@hust.edu.cn",{"name":100,"role":96,"phone":101,"phoneExt":59,"email":102},"Hongkun Di, BM","15931891138","hongkundi2020@163.com",{"type":104,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":59,"oldOrganization":59},"SPONSOR_INVESTIGATOR","Zhilei Shan","Professor","100578184","effects-of-zinc-supplementation-on-patients-with-elevated-glycemic-status-100578184",false,"NCT06807996","Effects of Zinc Supplementation on Patients With Elevated Glycemic Status","Effects of Zinc Supplementation on Patients With Elevated Glycemic Status: A Randomized Double-blind Placebo-controlled Clinical Trial","Inclusion Criteria:\n\n1. Fasting blood glucose ≥ 6.1 mmol \u002FL;\n2. HBA1c ≥ 5.7%;\n3. OGTT 2-hour or postprandial blood glucose ≥ 7.8 mmol\u002FL;\n4. Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years, or currently pregnant;\n2. Individuals with severe obesity, thyroid disease, cardiovascular or cerebrovascular diseases, or other serious health conditions;\n3. Individuals with a previous diagnosis of type 2 diabetes currently receiving insulin therapy;\n4. Individuals who have taken zinc-related supplements within three months prior to baseline inclusion;\n5. Individuals using other nutritional supplements or with poor lifestyle habits;\n6. Individuals with unstable body weight in the past three months (fluctuations \\> 5 kg);\n7. Individuals with a history of major surgery within the past three months or planned major surgery within the next month;\n8. Individuals allergic to the intervention materials;\n9. Individuals who did not adhere to the prescribed consumption of the study product, affecting efficacy or safety assessment;\n10. Individuals with positive urinary protein or serum creatinine greater than 1.2 times the upper limit of normal (men: serum creatinine \\> 133.2 μmol\u002FL, women: serum creatinine \\> 97.2 μmol\u002FL) at screening;\n11. Individuals with elevated alanine aminotransferase (ALT) levels at screening (men: ALT \\> 50 U\u002FL, women: ALT \\> 35 U\u002FL).","ALL","18 Years",{"count":117,"type":118},124,"ESTIMATED","INTERVENTIONAL",[121],"NA","The goal of this randomized, double-blind, placebo-controlled study included patients with elevated glycemic status is to investigate whether zinc supplementation (4mg per day) has beneficial effects on controlling blood glucose.",[124],"Elevated Blood Glucose","NOT_YET_RECRUITING","2025-05-09",{"date":128,"type":129},"2025-05-14","ACTUAL",{"date":131,"type":118},"2025-07-01",{"date":133,"type":118},"2025-12-01",{"name":105,"class":6}]