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

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ClinicalTrials.gov Identifier: NCT01463748
Recruitment Status : Completed
First Posted : November 2, 2011
Last Update Posted : July 3, 2013
National Science Council, Taiwan
Information provided by (Responsible Party):
Chun-Yu Yeh, Chung Shan Medical University

Brief Summary:
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 or disease Intervention/treatment Phase
Metabolic Syndrome Other: Graptopetalum paraguayense E. Walther Other: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : July 2011
Primary Completion Date : April 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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).

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463748

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chun-Yu Yeh, Assistant Professor, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT01463748     History of Changes
Other Study ID Numbers: CS11074
First Posted: November 2, 2011    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases