Effect of Standardized Large Yellow Tea Extract on Glucose and Lipid Metabolism in Overweight Adults With Hypertriglyceridemia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 主要终点
- Change From Baseline in Fasting Triglyceride Level at Week 12
研究概览
简要总结
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.
详细描述
This study is a multicenter, prospective, randomized, blinded, parallel-group controlled intervention trial conducted at the First Affiliated Hospital of USTC, Huangshan People's Hospital, and Lu'an People's Hospital in China.
Eligible participants will be adults aged 18 to 60 years who are overweight or obese, defined as a body mass index of at least 24.0 kg/m², and who have elevated fasting triglyceride levels without diagnosed diabetes or major cardiovascular disease. After screening and confirmation of eligibility, participants will be randomized in a 1:2 ratio to the placebo control group or the standardized large yellow tea extract group.
The intervention period will last 12 weeks. Both groups will receive standardized lifestyle guidance covering diet, physical activity, and sleep. Lifestyle-related factors will be assessed using dietary records, the International Physical Activity Questionnaire, and the Pittsburgh Sleep Quality Index. Adherence, concomitant medication use, and adverse events will be monitored throughout the intervention period.
Study visits are planned at screening, baseline, week 4, week 8, and week 12. Fasting blood samples will be collected for efficacy and safety assessments according to the study schedule. The primary efficacy endpoint is the change in fasting triglyceride concentration from baseline to week 12.
Secondary assessments include total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein A1, apolipoprotein B, fasting plasma glucose, fasting insulin, HOMA-IR, body weight, body mass index, waist circumference, blood pressure, and heart rate. Safety assessments include adverse events, laboratory safety parameters, and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study products will be packaged and dispensed using randomized codes. Participants, study care providers, investigators, laboratory personnel, outcome assessors, and statistical analysts will remain blinded to treatment assignment until database lock. Emergency unblinding will be permitted only when medically necessary.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participates in the study, fully understands the study objectives, procedures, and potential risks, and provides written informed consent.
- •Aged 18 to 60 years, either sex.
- •Body mass index (BMI) ≥24.0 kg/m², with body weight fluctuation <5% during the previous 3 months.
- •Elevated fasting triglyceride (TG) level, consistent with hypertriglyceridemia or a high-normal/elevated triglyceride status.
- •General health condition is stable, with no clinically significant abnormalities in vital signs or physical examination as judged by the investigator.
- •Baseline laboratory tests show no clinically significant abnormalities; complete blood count, liver function, and renal function are considered acceptable by the investigator for safe participation.
- •No diagnosis of diabetes mellitus and no regular use of glucose-lowering medications during the previous 3 months.
- •No regular use during the previous month of medications, dietary supplements, or tea extract products that may substantially affect glucose or lipid metabolism.
- •Able to understand and comply with the study requirements and willing to complete the 12-week intervention and follow-up, with acceptable anticipated adherence as judged by the investigator.
排除标准
- •Known or suspected allergy to tea, tea polyphenols, caffeine, or any component of the study products, or a history of severe allergic reactions.
- •Presence of any of the following cardiovascular or high-risk conditions:
- •Established coronary atherosclerotic heart disease, including myocardial infarction, unstable angina, or previous coronary revascularization;
- •Cerebrovascular disease, including stroke or transient ischemic attack;
- •Peripheral arterial disease;
- •Hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, or current use of antihypertensive medication;
- •Diagnosed type 1 or type 2 diabetes mellitus;
- •Other serious cardiovascular or cerebrovascular disease that, in the investigator's judgment, may increase participant risk or interfere with assessment of study outcomes.
- •Severe abnormalities of glucose or lipid metabolism, including diabetes mellitus.
- •Clinically significant baseline laboratory abnormalities, including ALT or AST >1.5 times the upper limit of normal, total bilirubin >1.5 times the upper limit of normal, significantly reduced renal function, or clinically significant abnormalities in complete blood count as judged by the investigator.
- •Use within the previous 3 months of lipid-lowering medications, weight-loss medications, long-term systemic glucocorticoids, or other medications that may substantially affect glucose or lipid metabolism; or regular use within the previous month of high-dose antioxidants, fish oil, plant sterols, tea extracts, or other products that may affect study outcomes.
- •Participation in another clinical trial within the previous 3 months, or blood donation/blood loss ≥400 mL within the previous 3 months.
- •Pregnant or breastfeeding women, women planning pregnancy during the study, or participants unwilling to use effective contraception when applicable.
- •Alcohol abuse, drug abuse, poor anticipated adherence, or any other condition considered by the investigator to make participation inappropriate.
研究组 & 干预措施
Standardized Large Yellow Tea Extract Group
Participants will receive standardized large yellow tea extract for 12 weeks together with standardized lifestyle guidance.
干预措施: Standardized Large Yellow Tea Extract (Dietary Supplement)
Placebo Control Group
Participants will receive a matching placebo for 12 weeks together with standardized lifestyle guidance.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change From Baseline in Fasting Triglyceride Level at Week 12
时间窗: Baseline and Week 12
Fasting serum triglyceride concentration will be measured at baseline and Week 12. The outcome will be calculated as the Week 12 value minus the baseline value and compared between the standardized large yellow tea extract group and the placebo control group.
次要结局
- Change From Baseline in Total Cholesterol at Week 12(Baseline and Week 12)
- Change From Baseline in Apolipoprotein A1 at Week 12(Baseline and Week 12)
- Change From Baseline in Apolipoprotein B at Week 12(Baseline and Week 12)
- Change From Baseline in Body Mass Index at Week 12(Baseline and Week 12)
- Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12(Baseline and Week 12)
- Number of Participants With Adverse Events(Baseline through Week 24)
- Change From Baseline in High-Density Lipoprotein Cholesterol at Week 12(Baseline and Week 12)
- Change From Baseline in Non-High-Density Lipoprotein Cholesterol at Week 12(Baseline and Week 12)
- Change From Baseline in Small Dense Low-Density Lipoprotein Cholesterol at Week 12(Baseline and Week 12)
- Change From Baseline in Fasting Plasma Glucose at Week 12(Baseline and Week 12)
- Change From Baseline in Fasting Insulin at Week 12(Baseline and Week 12)
- Change From Baseline in HOMA-IR at Week 12(Baseline and Week 12)
- Change From Baseline in Body Weight at Week 12(Baseline and Week 12)
- Change From Baseline in Waist Circumference at Week 12(Baseline and Week 12)
- Change From Baseline in Systolic Blood Pressure at Week 12(Baseline and Week 12)
- Change From Baseline in Diastolic Blood Pressure at Week 12(Baseline and Week 12)
- Change From Baseline in Heart Rate at Week 12(Baseline and Week 12)
- Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12(Baseline and Week 12)
- Change From Baseline in Body Fat Percentage at Week 12(Baseline and Week 12)
- Change From Baseline in Visceral Fat at Week 12(Baseline and Week 12)
研究者
Yongliang Zhang
Professor
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)