Standardized Large Yellow Tea Extract for Glucose and Lipid Metabolism in Overweight Adults With Hypertriglyceridemia

Prior treatment

• Presence of any of the following cardiovascular or high-risk conditions:
  • 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;
  • Hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, or current use of antihypertensive medication;
  • Diagnosed type 1 or type 2 diabetes mellitus;
  • Other serious cardiovascular or cerebrovascular disease that, in the investigator's judgment, may increase participant risk or interfere with assessment of study outcomes.
• Participation in another clinical trial within the previous 3 months, or blood donation/blood loss ≥400 mL within the previous 3 months.

Other illness

• Known or suspected allergy to tea, tea polyphenols, caffeine, or any component of the study products, or a history of severe allergic reactions.
• Alcohol abuse, drug abuse, poor anticipated adherence, or any other condition considered by the investigator to make participation inappropriate.

Lab values

• Severe abnormalities of glucose or lipid metabolism, including diabetes mellitus.
• 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.
• 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.

Other

• Pregnant or breastfeeding women, women planning pregnancy during the study, or participants unwilling to use effective contraception when applicable.

• 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.
• General health condition is stable, with no clinically significant abnormalities in vital signs or physical examination as judged by the investigator.
• 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.
• No diagnosis of diabetes mellitus and no regular use of glucose-lowering medications during the previous 3 months.
• No regular use during the previous month of medications, dietary supplements, or tea extract products that may substantially affect glucose or lipid metabolism.
• 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.