Explore the Effect of Gynostemma Pentaphyllum on Patients With Metabolic Syndrome

NCT ID: NCT05118698

Last Updated: 2022-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-03-01

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Gynostemma

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Gynostemma

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Spinach

Intervention Type: OTHER

For the spinach powder group, each patient will take spinach powder with nearly no saponin content, 3 times a day for 3 months.

Interventions

Gynostemma

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.

Intervention Type: DRUG

Spinach

For the spinach powder group, each patient will take spinach powder with nearly no saponin content, 3 times a day for 3 months.

Intervention Type: OTHER

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:

1. waist circumference ≥90 cm in men or ≥80 cm in women;

2. Elevated TG (drug treatment for elevated TG is an alternate indicator) ≥150 mg/dL (1.7 mmol/L);

3. 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;

4. 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;

5. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bingyin Shi

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanan Wang, professor

Role: CONTACT

y_wang@xjtufh.edu.cn

0086-13359242141

Qian Li, master

Role: CONTACT

liqian175@xjtufh.edu.cn

0086-18810920013

Facility Contacts

Bingyin Shi

Role: primary

0086-13700298366

Other Identifiers

XJTU1AF2021LSK-273

Identifier Type: -

Identifier Source: org_study_id