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

Chung Shan Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Metabolic Syndrome

Treatments: Other: Placebo; Other: Graptopetalum paraguayense E. Walther

Study type: Interventional

Funder types: Other

Identifiers

NCT01463748

CS11074

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Placebo

Experimental group

Description:

starch

Treatment:

Other: Placebo

Graptopetalum paraguayense E. Walther

Experimental group

Description:

Graptopetalum paraguayense E. Walther

Treatment:

Other: Graptopetalum paraguayense E. Walther