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

This study has been completed.
National Science Council, Taiwan
Information provided by (Responsible Party):
Chun-Yu Yeh, Chung Shan Medical University Identifier:
First received: October 31, 2011
Last updated: July 2, 2013
Last verified: July 2013
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.

Condition Intervention Phase
Metabolic Syndrome
Other: Graptopetalum paraguayense E. Walther
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Chung Shan Medical University:

Primary Outcome Measures:
  • Antioxidant and inflammation [ Time Frame: 12 weeks ]
    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.

Secondary Outcome Measures:
  • Blood biochemical values [ Time Frame: 12 weeks ]
    Fasting glucose, blood pressure, and blood lipid profiles(total cholesterol, triglyceride, low density lipoprotein and high density lipoprotein).

Enrollment: 54
Study Start Date: July 2011
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo
Other: Placebo
Other Name: starch
Experimental: Graptopetalum paraguayense E. Walther
Graptopetalum paraguayense E. Walther
Other: Graptopetalum paraguayense E. Walther
Graptopetalum paraguayense E. Walther


Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01463748

Chung Shan Medical University
Taichung, Taiwan, 40201
Sponsors and Collaborators
Chung Shan Medical University
National Science Council, Taiwan
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chun-Yu Yeh, Assistant Professor, Chung Shan Medical University Identifier: NCT01463748     History of Changes
Other Study ID Numbers: CS11074
Study First Received: October 31, 2011
Last Updated: July 2, 2013

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases processed this record on April 25, 2017