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.
The study will enroll healthy adults aged 18 to 45 years who meet predefined clinical and laboratory eligibility criteria. Participants will be randomized in a 1:1 ratio to one of two crossover sequences: Tea-Water (TW) or Water-Tea (WT). Each participant will therefore receive both interventions during the study. In the tea intervention period, participants will consume a single dose of 3 g of standardized large yellow tea extract dissolved in 250 mL of warm water. In the control period, participants will consume 250 mL of warm water. Both interventions will be administered immediately after completion of a standardized high-fat meal. The two intervention periods will be separated by a washout period of at least 7 days. On each study day, participants will arrive after an overnight fast. A baseline blood sample will be collected before consumption of the standardized high-fat meal. The meal will be completed within 20 minutes, followed immediately by the assigned study beverage, which will be consumed within 10 minutes. Additional blood samples will be collected at 0.5, 1, 1.5, 2, 4, and 6 hours after the meal. The primary outcome is the 0- to 6-hour incremental area under the curve for plasma triglycerides. Secondary outcomes include postprandial triglyceride kinetics, triglyceride peak concentration and time to peak, and selected lipid-related measures. Exploratory analyses will assess additional metabolic measures and plasma and urine metabolomic profiles to identify potential exposure biomarkers and metabolic pathways associated with the triglyceride response. Although the study is open-label to participants and study staff, biological samples will be coded, and laboratory personnel and statistical analysts will remain blinded to treatment assignment when feasible. Safety and tolerability will be assessed through adverse-event monitoring, vital signs, and relevant laboratory assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
A 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.
Participants 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.
Time frame: 0 to 6 hours after the standardized high-fat meal during each intervention period
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