Study on the Effect of 3T Pu'er Tea in Regulating Glucose and Lipid Metabolism
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Hepatic fat fraction indicators
研究概览
简要总结
To study the effect of Pu'er tea in overweight / obese patients with blood glucose or abnormal lipid metabolism. Compared with the effect of two Pu'er tea with different tea fuscin content in improving glucose and lipid metabolism, to investigate the mechanisms of bile acid metabolism and intestinal flora regulation.
In a prospective randomized controlled clinical study, 90 patients were divided into study group (3T Pu'er tea group, 45 patients) and control group ( traditional Pu'er tea group,45 patients). Before and after the treatment(0day, 12 weeks, 52 weeks) patients' markers of glucose and lipid metabolism were examined and compared.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The A、B should be simultaneously met, or combined with the C、D、E.
- •18-65 years, priority for patients over 30 years;
- •Overweight / obese patients: BMI ≥24 kg/m
- •Or combined with nonalcoholic fatty liver disease: determined by the hospital MRI nuclear magnetic quantification;
- •Or combined with dyslipidemia: blood total cholesterol TC≥6.4mmol/L or blood total triglyceride TG≥2.0mmol/L or blood low-density lipoprotein LDL-C≥3.1mmol/L;
- •Or with abnormal blood glucose:
- •Impaired fasting glucose, IFG: fasting blood glucose was 6.1~<7.0mmol/L,and 2 hours after 75g oral blood glucose tolerance test(OGTT) <7.8mmol / L.
- •Impaired glucose tolerance, IGT: the fasting blood glucose was <6.1mmol/L and 2 hours after 75gOGTT was 7.8~ <11.1 mmol / L;
- •IFG with IGT: patients with both IFG and IGT;
- •Patients with type 2 diabetes: random blood glucose 11.1mmol/L or fasting glucose of 7.0 mmol/L or 2 hours after OGTT.
排除标准
- •Type 2 diabetes and insulin injections or oral hypoglycemic drugs and other special types of diabetes.
- •For women during pregnancy or lactation or with allergies;
- •Patients treated with any hypoglycemic drugs and insulin injections; regular or planned patients taking drugs that may affect glucose and lipid metabolism (as judged by clinicians, such as diet pills, lipid-lowering drugs) and liver protection drugs (as judged by clinicians);
- •Patients with severe cardiovascular diseases, cerebrovascular diseases, liver, kidney, and hematopoietic diseases;
- •Combined with other infectious diseases, such as hepatitis A, hepatitis B, hepatitis C, and acquired immunodeficiency syndrome;
- •Take probiotics, prebiotics, antioxidants and fish oil nutrient supplements within 3 months;
- •Current smokers and regular drinking (excluding social drinkers only);
- •Yogurt intake within 1 week before the first visit and antibiotics within 3 months;
- •Drink strong tea regularly;
- •Participate in other clinical trials within 3 months;
- •Unable not cooperate with the investigator for other reasons.
- •Unfit for the researcherr.
结局指标
主要结局
Hepatic fat fraction indicators
时间窗: 52weeks
Siemens 3.0T medical MRI equipment was applied for MAFLD diagnosis and fat quantitative assessment.
Blood glucose
时间窗: 52weeks
Blood glucose were detected by the Roche COBAS C702 biochemical analyzer.Normal reference range：Fasting Blood Glucose 3.9-6.1 mmol/L.
Blood lipids
时间窗: 52weeks
Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.
Intestinal flora detection
时间窗: 52weeks
Polymerase Chain Reaction amplification was carried out in the v1-v9 variable region of the 16S rRN gene using universal primer (27F-1492R), and sequencing was conducted in the Illumina novaseq platform. The 16S rRNA amplicon sequence was processed using QIIME2. VSEARCH software was adopted to splice, filter, and remove chimeras from the original sequence to obtain the effective sequences. Clustering was performed according to the 99% similarity of the sequences to obtain the operational taxonomic units (OTU). Based on the Silva NR99 132 database, the representative sequences were analyzed and annotated. The OTU list was generated. The abundance and classification of all OTUs in the samples were recorded.
次要结局
- Alanine aminotransferase(52weeks)
- Creatinine(52weeks)
- Bone densitometry(52 weeks)
研究者
Chen Yuhua
Chief physician
Longgang District People's Hospital of Shenzhen