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.
Voluntarily participates in the study, fully understands the study objectives, procedures, and potential risks, and provides written informed consent.
Aged 18 to 60 years, either sex.
Body mass index (BMI) ≥24.0 kg/m², with body weight fluctuation <5% during the previous 3 months.
Elevated fasting triglyceride (TG) level, consistent with hypertriglyceridemia or a high-normal/elevated triglyceride status.
Known or suspected allergy to tea, tea polyphenols, caffeine, or any component of the study products, or a history of severe allergic reactions.
Established coronary atherosclerotic heart disease, including myocardial infarction, unstable angina, or previous coronary revascularization;
Cerebrovascular disease, including stroke or transient ischemic attack;
Peripheral arterial disease;
Parallel
Standardized Large Yellow Tea Extract
Dietary supplementStandardized 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.
Placebo
Dietary supplementMatching 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.
Change From Baseline in Total Cholesterol at Week 12
Change From Baseline in Apolipoprotein A1 at Week 12
Change From Baseline in Apolipoprotein B at Week 12
Change From Baseline in Body Mass Index at Week 12
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