Explore the Effect of Gynostemma Pentaphyllum on Patients With Metabolic Syndrome

NCT05118698 | Unknown

• 1 other identifier: XJTU1AF2021LSK-273
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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.

Study Arms (3)

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.

Drug: Gynostemma

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.

Drug: Gynostemma

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.

Other: Spinach

Interventions

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.

High-dose group; Low-dose group

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bingyin Shi

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Yanan Wang, professor

CONTACT

0086-13359242141; y_wang@xjtufh.edu.cn

Qian Li, master

CONTACT

0086-18810920013; liqian175@xjtufh.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 12, 2021
• Study Start: March 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: March 1, 2023
• Last Updated: July 11, 2022

Record last verified: 2022-05

Locations

CN (1)