Effects of Graptopetalum Paraguayense E. Walther on the Oxidative Stress, Antioxidant Enzyme Activity and Inflammation in Subjects With Metabolic Syndrome

Study Overview
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Brief Summary
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Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. The purposes of this study are going to investigate the effects of Graptopetalum paraguayense E. Walther on the oxidative stress, antioxidant enzyme activity and inflammation in subjects with metabolic syndromerelation. The investigators will recruit MS patients(n=50)and the inclusion criteria of MS are according to the Bureau of Health Promotion, Department of Health in Taiwan (2007). The MS subjects are randomly assigned to placebo(n=25) and Graptopetalum paraguayense E. Walther supplements(n=25)groups. Hopefully, the results of this study could provide the information of Graptopetalum paraguayense E. Walther supplements to what has been know in MS subjects.

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: Graptopetalum paraguayense E. Walther
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria of MS in adult are according to the Bureau of Health Promotion, Department of Health in Taiwan (2007), if subjects had 3 of the following 5 characteristics: (1) abdominal obesity (waist circumference >= 90 cm in men and >= 80 cm in women), (2) impaired fasting glucose ( >= 5.6 mmol/L), (3) hypertriglyceridemia ( >= 1.7 mmol/L), (4) low HDL-C (< 1.0 mmol/L in men and < 1.3 mmol/L in women), and (5) increased blood pressure (SBP >= 130 mmHg and DBP >= 85 mmHg). Subjects using antidiabetic or antihypertensive or lipid-lowering medications were considered to have elevated fasting blood glucose or elevated blood pressures or dyslipidemia, respectively. Exclusion Criteria: Subjects with liver, renal diseases, undergoing statin therapy, pregnancy women, and taking antioxidant vitamins supplements were excluded.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>starch | Other: Placebo<br>* starch<br>* Other names: starch;|
| Experimental: Graptopetalum paraguayense E. Walther<br>Graptopetalum paraguayense E. Walther | Other: Graptopetalum paraguayense E. Walther<br>* Graptopetalum paraguayense E. Walther<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antioxidant and inflammation | The study are going to measure the concentrations of lipid peroxidation markers (TBARS and ox-LDL) and antioxidant enzymes activities (catalase, glutathione peroxidase, and superoxide dismutase), and the level of inflammatory markers (hs-CRP, TNF-alfa, IL-1, IL-6 and adiponectin) in all subjects of this study. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood biochemical values | Fasting glucose, blood pressure, and blood lipid profiles(total cholesterol, triglyceride, low density lipoprotein and high density lipoprotein). | 12 weeks |