Clinical trials

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 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.