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NCT07840846
Standardized Large Yellow Tea Extract for Glucose and Lipid Metabolism in Overweight Adults With Hypertriglyceridemia
Conditions: Hypertriglyceridemia, Overweight , Obesity
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 138
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.
Eligibility Criteria
Inclusion Criteria:
1. Voluntarily participates in the study, fully understands the study objectives, procedures, and potential risks, and provides written informed consent.
2. Aged 18 to 60 years, either sex.
3. Body mass index (BMI) ≥24.0 kg/m², with body weight fluctuation \
Source: ClinicalTrials.gov (NCT07840846). StuddyBuddy aggregates publicly available trial information.