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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose group | Experimental | Participants will be allowed to drink Gynostemma pentaphyllum powder containing 12% saponin, 2 g each time, 3 times a day for 3 months. |
|
| Low-dose group | Experimental | Participants will be allowed to drink Gynostemma pentaphyllum powder containing 8% saponin, 2 g each time, 3 times a day for 3 months. |
|
| Placebo group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gynostemma | Drug | Patients in the high-dose group and low-dose group will take gynostemma powder with a saponin content of 12% and 8% respectively, 3 times a day for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of weight | Kg | From date of randomization to the last follow-up, once a month, assessed up to 3 months. |
| change of blood lipid level | mmol/L | From date of randomization to the last follow-up, once a month, assessed up to 3 months. |
| change of blood glucose level | mmol/L | From date of randomization to the last follow-up, once a month, assessed up to 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| change of waistline and hipline | cm | From date of randomization to the last follow-up, once a month, assessed up to 3 months. |
| change of blood pressure | mmHg |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanan Wang, professor | Contact | 0086-13359242141 | y_wang@xjtufh.edu.cn | |
| Qian Li, master | Contact | 0086-18810920013 | liqian175@xjtufh.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Bingyin Shi | First Affiliated Hospital Xi'an Jiaotong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Spinach | Other | For the spinach powder group, each patient will take spinach powder with nearly no saponin content, 3 times a day for 3 months. |
|
| From date of randomization to the last follow-up, once a month, assessed up to 3 months. |
| change of glucose tolerance | mmol/L | The date of first enrollment and 3 months after the intervention. |
| change of serum insulin level | pmol/L | The date of first enrollment and 3 months after the intervention. |
| change of serum C peptide level | pmol/L | The date of first enrollment and 3 months after the intervention. |
| D009750 |
| Nutritional and Metabolic Diseases |