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

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Graptopetalum paraguayense E. Walther

Placebo

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chung Shan Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Placebo

Graptopetalum paraguayense E. Walther

Arm Description

starch

Graptopetalum paraguayense E. Walther

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Blood biochemical values

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

Full Information

NCT ID

NCT01463748

First Posted

October 31, 2011

Last Updated

July 2, 2013

Sponsor

Chung Shan Medical University

Collaborators

National Science Council, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT01463748

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chung Shan Medical University

Collaborators

National Science Council, Taiwan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Experimental

Arm Description

starch

Arm Title

Graptopetalum paraguayense E. Walther

Arm Type

Experimental

Arm Description

Graptopetalum paraguayense E. Walther

Intervention Type

Other

Intervention Name(s)

Graptopetalum paraguayense E. Walther

Intervention Description

Graptopetalum paraguayense E. Walther

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

starch

Intervention Description

starch

Primary Outcome Measure Information:

Title

Antioxidant and inflammation

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Blood biochemical values

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Chung Shan Medical University

City

Taichung

ZIP/Postal Code

40201

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

24371832

Citation

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.

Results Reference

derived

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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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