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.
Participants 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.
Blood 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.
Voluntary participation in the study, with full understanding of the study objectives, procedures, and potential risks, and provision of written informed consent.
Healthy adults aged 18 to 45 years, male or female.
Body mass index (BMI) of 18.5 to 24.0 kg/m², with relatively stable body weight (change <5% during the previous 3 months).
Systolic blood pressure: 90-139 mmHg;
Known or suspected allergy to tea, tea polyphenols, caffeine, theanine, or any component of the study product, or a history of severe allergic reactions.
History or current presence of clinically important cardiovascular, hepatic, renal, gastrointestinal, endocrine/metabolic, neurological, psychiatric, or other systemic disease that, in the investigator's judgment, may affect participant safety or study outcomes.
Any history of malignant tumor or current treatment for malignancy.
ALT or AST >1.5 × ULN;
Crossover
Standardized Large Yellow Tea Extract
Dietary supplementA single dose of 3 g of standardized large yellow tea extract is dissolved in 250 mL of warm water at 60±5°C and consumed within 10 minutes immediately after completion of the standardized high-fat meal.
Warm Water Control
Other interventionParticipants consume 250 mL of warm water at 60±5°C within 10 minutes immediately after completion of the standardized high-fat meal as the control intervention.
Postprandial Plasma Triglyceride Incremental Area Under the Curve From 0 to 6 Hours (TG iAUC0-6h)
The incremental area under the curve (iAUC) for plasma triglyceride concentrations will be calculated relative to the fasting baseline value using the trapezoidal method. Plasma triglycerides will be measured at 0 (baseline), 0.5, 1, 1.5, 2, 4, and 6 hours after the standardized high-fat meal.
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