[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100657618","standardized-large-yellow-tea-extract-for-glucose-and-lipid-metabolism-in-overweight-adults-with-hypertriglyceridemia-100657618",false,"NCT07840846","Standardized Large Yellow Tea Extract for Glucose and Lipid Metabolism in Overweight Adults With Hypertriglyceridemia","Effect of Standardized Large Yellow Tea Extract on Glucose and Lipid Metabolism in Overweight Adults With Hypertriglyceridemia: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Voluntarily participates in the study, fully understands the study objectives, procedures, and potential risks, and provides written informed consent.\n2. Aged 18 to 60 years, either sex.\n3. Body mass index (BMI) ≥24.0 kg\u002Fm², with body weight fluctuation \\\u003C5% during the previous 3 months.\n4. Elevated fasting triglyceride (TG) level, consistent with hypertriglyceridemia or a high-normal\u002Felevated triglyceride status.\n5. General health condition is stable, with no clinically significant abnormalities in vital signs or physical examination as judged by the investigator.\n6. Baseline laboratory tests show no clinically significant abnormalities; complete blood count, liver function, and renal function are considered acceptable by the investigator for safe participation.\n7. No diagnosis of diabetes mellitus and no regular use of glucose-lowering medications during the previous 3 months.\n8. No regular use during the previous month of medications, dietary supplements, or tea extract products that may substantially affect glucose or lipid metabolism.\n9. Able to understand and comply with the study requirements and willing to complete the 12-week intervention and follow-up, with acceptable anticipated adherence as judged by the investigator.\n\nExclusion Criteria:\n\n1. Known or suspected allergy to tea, tea polyphenols, caffeine, or any component of the study products, or a history of severe allergic reactions.\n2. Presence of any of the following cardiovascular or high-risk conditions:\n\n   * Established coronary atherosclerotic heart disease, including myocardial infarction, unstable angina, or previous coronary revascularization;\n   * Cerebrovascular disease, including stroke or transient ischemic attack;\n   * Peripheral arterial disease;\n   * Hypertension, defined as systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg, or current use of antihypertensive medication;\n   * Diagnosed type 1 or type 2 diabetes mellitus;\n   * Other serious cardiovascular or cerebrovascular disease that, in the investigator's judgment, may increase participant risk or interfere with assessment of study outcomes.\n3. Severe abnormalities of glucose or lipid metabolism, including diabetes mellitus.\n4. Clinically significant baseline laboratory abnormalities, including ALT or AST \\>1.5 times the upper limit of normal, total bilirubin \\>1.5 times the upper limit of normal, significantly reduced renal function, or clinically significant abnormalities in complete blood count as judged by the investigator.\n5. Use within the previous 3 months of lipid-lowering medications, weight-loss medications, long-term systemic glucocorticoids, or other medications that may substantially affect glucose or lipid metabolism; or regular use within the previous month of high-dose antioxidants, fish oil, plant sterols, tea extracts, or other products that may affect study outcomes.\n6. Participation in another clinical trial within the previous 3 months, or blood donation\u002Fblood loss ≥400 mL within the previous 3 months.\n7. Pregnant or breastfeeding women, women planning pregnancy during the study, or participants unwilling to use effective contraception when applicable.\n8. Alcohol abuse, drug abuse, poor anticipated adherence, or any other condition considered by the investigator to make participation inappropriate.","ALL","18 Years","60 Years",{"count":20,"type":21},138,"ESTIMATED","INTERVENTIONAL",[24],"NA","This multicenter, prospective, randomized, blinded, parallel-group controlled trial will evaluate the effects of standardized large yellow tea extract on glucose and lipid metabolism in overweight adults with elevated triglyceride levels.\n\nApproximately 138 participants aged 18 to 60 years will be enrolled at three study centers in China and randomly assigned in a 1:2 ratio to a placebo control group or a standardized large yellow tea extract group. Participants will receive the assigned intervention for 12 weeks, together with standardized lifestyle guidance.\n\nThe primary objective is to compare the change in fasting triglyceride levels from baseline to week 12 between the two groups. Secondary objectives include evaluating changes in other lipid parameters, glucose metabolism, body weight, body mass index, waist circumference, blood pressure, and safety and tolerability. Exploratory analyses will assess plasma and\u002For urine metabolomic profiles and potential biomarkers related to response to the tea intervention.\n\nParticipants will also be followed through week 24 for longer-term safety assessment and changes in glucose and lipid metabolism.",[27,28],"Hypertriglyceridemia","Overweight , Obesity",[30,31,32,33,34],"Large Yellow Tea","Triglycerides","Lipid Metabolism","Glucose Metabolism","Metabolomics","NOT_YET_RECRUITING","2026-09-19",{"date":38,"type":39},"2026-09-25","ACTUAL",{"date":41,"type":21},"2026-09",{"date":43,"type":21},"2028-03",{"name":45,"class":46},"The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100656524","effect-of-standardized-large-yellow-tea-extract-on-triglyceride-response-after-a-high-fat-meal-in-healthy-adults-100656524","NCT07824609","Effect of Standardized Large Yellow Tea Extract on Triglyceride Response After a High-Fat Meal in Healthy Adults","Effect of Standardized Large Yellow Tea Extract on Postprandial Triglyceride Response to a High-Fat Meal in Healthy Adults: A Randomized Crossover Controlled Trial","Inclusion Criteria:\n\n1. Voluntary participation in the study, with full understanding of the study objectives, procedures, and potential risks, and provision of written informed consent.\n2. Healthy adults aged 18 to 45 years, male or female.\n3. Body mass index (BMI) of 18.5 to 24.0 kg\u002Fm², with relatively stable body weight (change \\\u003C5% during the previous 3 months).\n4. Generally normal physical examination and vital signs, including:\n\n   * Systolic blood pressure: 90-139 mmHg;\n   * Diastolic blood pressure: 60-89 mmHg;\n   * Resting heart rate: 50-100 beats\u002Fmin;\n   * No clinically significant abnormal physical findings.\n5. Baseline laboratory results meeting the following criteria:\n\n   * Complete blood count within the reference range, or minor deviations considered clinically insignificant by the investigator;\n   * ALT, AST, ALP, GGT, and total bilirubin within the upper limit of normal (ULN), or no more than 1.2 × ULN and considered clinically insignificant by the investigator;\n   * Serum creatinine and blood urea nitrogen within the reference range and estimated glomerular filtration rate (eGFR) ≥90 mL\u002Fmin\u002F1.73 m²;\n   * Fasting plasma glucose approximately 3.9-6.1 mmol\u002FL, without a diagnosis of diabetes or prediabetes;\n   * Triglycerides \\\u003C2.3 mmol\u002FL and LDL-C \\\u003C4.1 mmol\u002FL, or according to the reference ranges of the local laboratory and investigator judgment.\n6. No history of serious cardiovascular, hepatic, renal, gastrointestinal, respiratory, neurological, hematological, endocrine, or other major systemic disease, or only mild chronic conditions considered by the investigator not to substantially affect study safety or outcomes.\n7. No known allergy to tea or its components, including tea polyphenols or caffeine, and no history of serious adverse reactions after tea or caffeine-containing beverages.\n8. No regular use during the previous month of lipid-lowering drugs, glucose-lowering drugs, antihypertensive drugs, glucocorticoids, high-dose antioxidant supplements, weight-loss products, or other medications or supplements that may affect glucose or lipid metabolism or pharmacokinetic outcomes.\n9. Moderate intake of tea, coffee, and other caffeine-containing beverages during the previous week, and willingness to restrict other tea and caffeine-containing beverages from 3 days before the study until completion of the study.\n10. No alcohol abuse or drug abuse.\n11. Ability and willingness to comply with all study procedures, including scheduled visits, blood and urine sampling, and recording of medications and adverse events.\n\nExclusion Criteria:\n\n1. Known or suspected allergy to tea, tea polyphenols, caffeine, theanine, or any component of the study product, or a history of severe allergic reactions.\n2. History or current presence of clinically important cardiovascular, hepatic, renal, gastrointestinal, endocrine\u002Fmetabolic, neurological, psychiatric, or other systemic disease that, in the investigator's judgment, may affect participant safety or study outcomes.\n3. Any history of malignant tumor or current treatment for malignancy.\n4. Clinically significant baseline laboratory abnormalities, including but not limited to:\n\n   * ALT or AST \\>1.5 × ULN;\n   * Total bilirubin \\>1.5 × ULN;\n   * Serum creatinine above the upper limit of normal or eGFR \\\u003C90 mL\u002Fmin\u002F1.73 m²;\n   * Clinically significant abnormalities in complete blood count;\n   * Fasting plasma glucose ≥6.1 mmol\u002FL or HbA1c ≥6.5%.\n5. Use within the previous 3 months of lipid-lowering drugs, glucose-lowering drugs, long-term systemic glucocorticoids, anticoagulants, antiarrhythmic drugs, or strong enzyme-inducing or transporter-modifying drugs that may interfere with study outcomes.\n6. Regular use within the previous month of high-dose antioxidants, dietary supplements, herbal preparations, green tea extract, grape seed extract, ginseng, Ganoderma lucidum, or other lipid- or glucose-modifying supplements considered likely to interfere with the study.\n7. Participation in another clinical trial or healthy-volunteer study within the previous 3 months, receipt of an investigational drug or device, or blood donation\u002Fblood loss ≥400 mL within the previous 3 months.\n8. Alcohol or drug abuse, or marked caffeine sensitivity causing symptoms such as palpitations, insomnia, tremor, or anxiety after small amounts of coffee, strong tea, or other caffeine-containing beverages.\n9. Pregnancy, breastfeeding, planned pregnancy within the next 3 months, or refusal by women of childbearing potential to use reliable contraception during the study.\n10. Significant circadian rhythm disturbance, long-term night-shift or rotating-shift work, severely irregular sleep, or anticipated travel\u002Fwork scheduling likely to interfere with study visits or sampling.\n11. Any condition considered by the investigator likely to result in poor compliance or inability to complete study procedures.\n12. Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation.",true,"45 Years",{"count":57,"type":21},24,[24],"This study is a single-center, prospective, open-label, randomized 2×2 crossover controlled trial in healthy adults aged 18 to 45 years. The study aims to evaluate the acute effect of a standardized large yellow tea extract on triglyceride responses after a standardized high-fat meal.\n\nParticipants will be randomly assigned to one of two intervention sequences. In one study period, participants will consume 3 g of standardized large yellow tea extract dissolved in 250 mL of warm water after a standardized high-fat meal. In the other period, they will consume 250 mL of warm water as the control. The two study periods will be separated by a washout period of at least 7 days.\n\nBlood samples will be collected before the meal and at 0.5, 1, 1.5, 2, 4, and 6 hours after the meal. The primary outcome is the incremental area under the curve for plasma triglycerides from 0 to 6 hours. Secondary and exploratory outcomes include other postprandial lipid and metabolic measures, safety and tolerability, and plasma and urine metabolomic profiles.",[61],"Postprandial Lipemia",[30,63,64,65,66,34,67],"Postprandial Triglycerides","High-Fat Meal","Oral Fat Tolerance Test","Crossover Trial","Healthy Adults","2026-09-15",{"date":70,"type":39},"2026-09-17",{"date":41,"type":21},{"date":73,"type":21},"2026-11",{"name":45,"class":46},""]