An interventional study of Standardized Large Yellow Tea Extract and Placebo in Hypertriglyceridemia and Overweight , Obesity, sponsored by The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial). Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial) · Not applicable, Interventional, and Treatment
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.
Approximately 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.
The 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/or urine metabolomic profiles and potential biomarkers related to response to the tea intervention.
Participants will also be followed through week 24 for longer-term safety assessment and changes in glucose and lipid metabolism.
This study is a multicenter, prospective, randomized, blinded, parallel-group controlled intervention trial conducted at the First Affiliated Hospital of USTC, Huangshan People's Hospital, and Lu'an People's Hospital in China.
Eligible participants will be adults aged 18 to 60 years who are overweight or obese, defined as a body mass index of at least 24.0 kg/m², and who have elevated fasting triglyceride levels without diagnosed diabetes or major cardiovascular disease. After screening and confirmation of eligibility, participants will be randomized in a 1:2 ratio to the placebo control group or the standardized large yellow tea extract group.
The intervention period will last 12 weeks. Both groups will receive standardized lifestyle guidance covering diet, physical activity, and sleep. Lifestyle-related factors will be assessed using dietary records, the International Physical Activity Questionnaire, and the Pittsburgh Sleep Quality Index. Adherence, concomitant medication use, and adverse events will be monitored throughout the intervention period.
Study visits are planned at screening, baseline, week 4, week 8, and week 12. Fasting blood samples will be collected for efficacy and safety assessments according to the study schedule. The primary efficacy endpoint is the change in fasting triglyceride concentration from baseline to week 12.
Secondary assessments include total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein A1, apolipoprotein B, fasting plasma glucose, fasting insulin, HOMA-IR, body weight, body mass index, waist circumference, blood pressure, and heart rate. Safety assessments include adverse events, laboratory safety parameters, and tolerability.
Exploratory analyses will investigate changes in plasma and/or urine metabolomic profiles, identify metabolites associated with exposure to large yellow tea extract, and explore associations between candidate biomarkers and triglyceride response.
After completion of the 12-week intervention, participants will continue follow-up through week 24 for evaluation of longer-term safety and changes in glucose and lipid metabolism.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's planned enrollment of 138 is above the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial) is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Presence of any of the following cardiovascular or high-risk conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive standardized large yellow tea extract for 12 weeks together with standardized lifestyle guidance.
Dietary Supplement: Standardized Large Yellow Tea Extract
Participants will receive a matching placebo for 12 weeks together with standardized lifestyle guidance.
Dietary Supplement: Placebo
Standardized large yellow tea extract powder, 3 g per dose, administered orally twice daily, approximately 30 minutes after breakfast and 30 minutes after dinner, for 12 weeks. The product is prepared in 200-300 mL of warm water and consumed within 10 minutes.
Matching placebo powder containing excipients such as maltodextrin and vitamin C and no active large yellow tea components. The placebo is matched to the active product in appearance, color, taste, packaging, and administration schedule and is given for 12 weeks.
Change From Baseline in Fasting Triglyceride Level at Week 12
Fasting serum triglyceride concentration will be measured at baseline and Week 12. The outcome will be calculated as the Week 12 value minus the baseline value and compared between the standardized large yellow tea extract group and the placebo control group.
Time frame: Baseline and Week 12
Change From Baseline in Total Cholesterol at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Apolipoprotein A1 at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Apolipoprotein B at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Body Mass Index at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12
Low-density lipoprotein cholesterol (LDL-C) will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
Number of Participants With Adverse Events
Time frame: Baseline through Week 24
Change From Baseline in High-Density Lipoprotein Cholesterol at Week 12
High-density lipoprotein cholesterol (HDL-C) will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
Change From Baseline in Non-High-Density Lipoprotein Cholesterol at Week 12
Non-high-density lipoprotein cholesterol (non-HDL-C) will be calculated as total cholesterol minus HDL-C at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value
Time frame: Baseline and Week 12
Change From Baseline in Small Dense Low-Density Lipoprotein Cholesterol at Week 12
Small dense low-density lipoprotein cholesterol (sdLDL-C) will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
Change From Baseline in Fasting Plasma Glucose at Week 12
Fasting plasma glucose will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
Change From Baseline in Fasting Insulin at Week 12
Fasting insulin will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
Change From Baseline in HOMA-IR at Week 12
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated from fasting plasma glucose and fasting insulin measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
Change From Baseline in Body Weight at Week 12
Body weight will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
Change From Baseline in Waist Circumference at Week 12
Waist circumference will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
Change From Baseline in Systolic Blood Pressure at Week 12
Systolic blood pressure will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure at Week 12
Diastolic blood pressure will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
Change From Baseline in Heart Rate at Week 12
Heart rate will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Glycated hemoglobin (HbA1c) will be measured at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
Change From Baseline in Body Fat Percentage at Week 12
Body fat percentage will be measured using the prespecified body composition assessment method at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
Change From Baseline in Visceral Fat at Week 12
Visceral fat will be assessed using the prespecified body composition assessment method at baseline and Week 12. Change from baseline will be calculated as the Week 12 value minus the baseline value.
Time frame: Baseline and Week 12
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)