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.
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: July 2, 2013
Last verified: July 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ 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.


Secondary Outcome Measures:
  • 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).


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

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463748

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

No publications provided by Chung Shan Medical University

Additional 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
Study First Received: October 31, 2011
Last Updated: July 2, 2013
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on September 14, 2014