Explore the Effect of Gynostemma Pentaphyllum on Patients With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
An Intervention Study of Gynostemma Pentaphyllum in Patients With Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: Gynostemma
* Other: Spinach


Participation Criteria
=================
Eligibility Criteria
-----------------
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: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose group<br>Participants will be allowed to drink Gynostemma pentaphyllum powder containing 12% saponin, 2 g each time, 3 times a day for 3 months. | Drug: Gynostemma<br>* 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.<br>|
| Experimental: Low-dose group<br>Participants will be allowed to drink Gynostemma pentaphyllum powder containing 8% saponin, 2 g each time, 3 times a day for 3 months. | Drug: Gynostemma<br>* 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.<br>|
| Placebo Comparator: Placebo group<br>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. | Other: Spinach<br>* For the spinach powder group, each patient will take spinach powder with nearly no saponin content, 3 times a day for 3 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |