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Standardized Large Yellow Tea Extract for Glucose and Lipid Metabolism in Overweight Adults With Hypertriglyceridemia
Sponsor: The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Summary
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.
Official title: Effect of Standardized Large Yellow Tea Extract on Glucose and Lipid Metabolism in Overweight Adults With Hypertriglyceridemia: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
138
Start Date
2026-09
Completion Date
2028-03
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
Standardized Large Yellow Tea Extract
Standardized 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
Matching 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.