An Intervention Study of Gynostemma Pentaphyllum in Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- change of weight
研究概览
简要总结
Previous research shows that gypenoside could keep blood lipid and blood sugar under control in an effective way. In this study, we intend to explore whether gypenosides have clinical improvement effects on metabolic diseases such as diabetes, hyperlipidemia, and non-alcoholic fatty liver and their cardiovascular protective potential. It is designed to recruit 150 patients with metabolic syndrome diagnosed who meet the criteria for enrollment, and randomly divide them into three groups. Gynostemma powder, with two different saponins content (12% and 8%) from Pingli County, Shaanxi Province, and spinach powder with almost no saponins were used to conduct the intervention on patients. Patients will be followed up regularly at the beginning of each month from the first enrollment until the third month. At each follow-up, data of patient's anthropometric indicators as well as clinical inspection indicators related to metabolism (blood routine, liver function, etc.) will be recorded. In addition, patient's blood, hair, urine, and stool samples will be collected to further explore the mechanism of diseases.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low-density lipoprotein (LDL) cholesterol ≥130 mg/dL (3.4 mmol/L ), or conforms to the diagnosis criteria for metabolic syndrome (based on the MetS diagnostic criteria developed by IDF and AHA in 2009), that is, having three or more of the following traits:
- •waist circumference ≥90 cm in men or ≥80 cm in women;
- •Elevated TG (drug treatment for elevated TG is an alternate indicator) ≥150 mg/dL (1.7 mmol/L);
- •Reduced HDL-c (drug treatment for reduced HDL-c is an alternate indicator) < 40 mg/dL (1.03 mmol/L) in males < 50 mg/dL (1.29 mmol/L) in females;
- •Elevated blood pressure (anti-hypertensive drug treatment in a patient with a history of hypertension is an alternate indicator). Systolic ≥ 130 and/or diastolic ≥ 85 mmHg;
- •Elevated fasting glucose (drug treatment for elevated glucose is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L).
- •Be over 18 years old or younger than 80 years old, no gender limit.
- •Have a good follow-up compliance and can be followed up for more than 3 months;
- •From 2 weeks before enrollment to the end of the entire trial, the treatment regimen will not change.
排除标准
- •Pregnant and lactating women;
- •Allergic or toxic reactions to gynostemma and other drugs;
- •Infectious diseases such as viral hepatitis, AIDS, syphilis, tuberculosis are active;
- •After drug treatment, still showing high blood sugar (fasting blood glucose higher than 200mg/dL, 11.1mmol/L) or hyperlipidemia, or hypertension (higher than 180/110 mmHg);
- •Any conditions judged by the investigator that affect enrollment.
研究组 & 干预措施
High-dose group
Participants will be allowed to drink Gynostemma pentaphyllum powder containing 12% saponin, 2 g each time, 3 times a day for 3 months.
干预措施: Gynostemma (Drug)
Low-dose group
Participants will be allowed to drink Gynostemma pentaphyllum powder containing 8% saponin, 2 g each time, 3 times a day for 3 months.
干预措施: Gynostemma (Drug)
Placebo group
Participants will be allowed to drink a placebo of spinach powder with almost no saponin content, 2 g each time, 3 times a day for 3 months.
干预措施: Spinach (Other)
结局指标
主要结局
change of weight
时间窗: From date of randomization to the last follow-up, once a month, assessed up to 3 months.
Kg
change of blood lipid level
时间窗: From date of randomization to the last follow-up, once a month, assessed up to 3 months.
mmol/L
change of blood glucose level
时间窗: From date of randomization to the last follow-up, once a month, assessed up to 3 months.
mmol/L
次要结局
- change of waistline and hipline(From date of randomization to the last follow-up, once a month, assessed up to 3 months.)
- change of blood pressure(From date of randomization to the last follow-up, once a month, assessed up to 3 months.)
- change of glucose tolerance(The date of first enrollment and 3 months after the intervention.)
- change of serum insulin level(The date of first enrollment and 3 months after the intervention.)
- change of serum C peptide level(The date of first enrollment and 3 months after the intervention.)