Effects of Graptopetalum Paraguayense E. Walther on the Oxidative Stress, Antioxidant Enzyme Activity and Inflammation in Subjects With Metabolic Syndrome
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 31, 2011
CompletedFirst Posted
Study publicly available on registry
November 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedJuly 3, 2013
July 1, 2013
1.8 years
October 31, 2011
July 2, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Blood biochemical values
12 weeks
Study Arms (2)
Placebo
EXPERIMENTALstarch
Graptopetalum paraguayense E. Walther
EXPERIMENTALGraptopetalum paraguayense E. Walther
Interventions
Graptopetalum paraguayense E. Walther
Eligibility Criteria
You may not qualify if:
- Subjects with liver, renal diseases, undergoing statin therapy, pregnancy women, and taking antioxidant vitamins supplements were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung Shan Medical University
Taichung, 40201, Taiwan
Related Publications (1)
Yen CH, Chen SJ, Liu JT, Tseng YF, Lin PT. Effects of water extracts of Graptopetalum paraguayense on blood pressure, fasting glucose, and lipid profiles of subjects with metabolic syndrome. Biomed Res Int. 2013;2013:809234. doi: 10.1155/2013/809234. Epub 2013 Nov 25.
PMID: 24371832DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 31, 2011
First Posted
November 2, 2011
Study Start
July 1, 2011
Primary Completion
April 1, 2013
Last Updated
July 3, 2013
Record last verified: 2013-07