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

This study is currently recruiting participants.

Verified October 2011 by Chung Shan Medical University

Sponsor:

Collaborator:

National Science Council, Taiwan

Information provided by (Responsible Party):

Chun-Yu Yeh, Chung Shan Medical University

ClinicalTrials.gov Identifier:

NCT01463748

First received: October 31, 2011

Last updated: NA

Last verified: October 2011

History: No changes posted

Tracking Information

First Received Date ^ICMJE

October 31, 2011

Last Updated Date

October 31, 2011

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Antioxidant and inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Blood biochemical values [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Fasting glucose, blood pressure, and blood lipid profiles(total cholesterol, triglyceride, low density lipoprotein and high density lipoprotein).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Condition ^ICMJE

Metabolic Syndrome

Intervention ^ICMJE

Other: Graptopetalum paraguayense E. Walther
Graptopetalum paraguayense E. Walther

Other Name: Graptopetalum paraguayense E. Walther
Other: Placebo
starch

Other Name: starch

Study Arm (s)

Experimental: Placebo
starch

Intervention: Other: Placebo
Experimental: Graptopetalum paraguayense E. Walther
Graptopetalum paraguayense E. Walther

Intervention: Other: Graptopetalum paraguayense E. Walther

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2012

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ping-Ting Lin, Ph.D.

+886-2473-0022 ext 12187

apt810@csmu.edu.tw

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01463748

Other Study ID Numbers ^ICMJE

CS11074

Has Data Monitoring Committee

Yes

Responsible Party

Chun-Yu Yeh, Chung Shan Medical University

Study Sponsor ^ICMJE

Chung Shan Medical University

Collaborators ^ICMJE

National Science Council, Taiwan

Investigators ^ICMJE

Not Provided

Information Provided By

Chung Shan Medical University

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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