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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01463748
Enrollment
54
Registered
2011-11-02
Start date
2011-07-31
Completion date
Unknown
Last updated
2013-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

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.

Interventions

OTHERGraptopetalum paraguayense E. Walther

Graptopetalum paraguayense E. Walther

OTHERPlacebo

starch

Sponsors

National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
Chung Shan Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Antioxidant and inflammation12 weeksThe 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

MeasureTime frameDescription
Blood biochemical values12 weeksFasting glucose, blood pressure, and blood lipid profiles(total cholesterol, triglyceride, low density lipoprotein and high density lipoprotein).

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026