NCT06592365招募中不适用
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effects and Safety of Green Tea Extract(GTE) Consumption on Blood Glucose Regulation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 3
- 主要终点
- Change in fasting glucose level
研究概览
简要总结
This study was conducted to investigate the effects of green tea extracts on reducing blood glucose level
详细描述
This study was conducted over 12 weeks with a randomized, double-blind, placebo-controlled, parellel design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged between 19 to 64 years
- •BMI between 18.5 and 29.9kg/m²
- •fasting blood glucose between 100 and 139 mg/dL (Note: if some subjects with blood glucose range of 126 - 139 mg/dL, those who are taking or requre medication must be excluded to meet ethical standards.)
- •subjects who voluntarily decide to participate in this study and sign the informed consent form.
排除标准
- •Individuals taking to obesity, dyslipidemia, or uncontrolled hypertension at the screening
- •Individuals diagnosed with diabetes and who have taken medications related to blood glucose
- •Individuals congenital enzyme deficiencies related to sugar metabolism.
- •with hypersensitivity to the test food or ingredients(e.g., green tea, caffeine).
- •Individuals ongoing treatment diseases significantly related glucose metabolism.
- •Individuals with a history of surgery significantly related to glucose metabolism within the last 6 months
- •diagnosed with gastrointestinal diseases, cardiovascular diseases, uncontrolled chronic medical conditions, thyroid disorders, or active malignant tumors requiring medication
- •Individuals with liver function impairment or acute or chronic hepatitis or liver cirrhosis
- •Individuals with renal disorder
- •Individuals with a weight change of 5 kg or more within the last 3 months.
结局指标
主要结局
Change in fasting glucose level
时间窗: Baseline, week 12
blood glucose level detection
次要结局
- changes of indicator of lipid metabolism(Baseline, week 12)
- OGTT(Baseline, week 12)
- blood biomarkers(Baseline, week 12)
- change in waist circumference(cm)(Baseline, week 12)
研究者
研究点 (3)
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