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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07840846
Lead Sponsor The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Conditions
(from sponsor)
Hypertriglyceridemia, Overweight , Obesity
Related terms Hypertriglyceridemia, Obesity, Overweight
Enrollment 138 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov