The Effect of Metamin 3D on the Lipid and Glucose in Subjects With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Phase 3 Study of 3D in Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120873
• Other study ID #: S06203
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2010
• Last updated: May 10, 2010
• Start date: March 2007
• Est. completion date: June 2009

Study information

• Verified date: May 2010
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To evaluate the effect of Metamin 3D on improvement of glucose and lipid on Taiwanese subjects with metabolic syndrome.

Description:

The Metamin 3D consists of mixed extractives of nature plants, including soy bean protein, bitter melon, red yeast rice, green algae and trisodium glycyrrhizinate. the improvement of lipid and glucose was reported respectively previously. We design a prospective, double-blinded and placebo-controlled study to evaluate the improvement on metabolic syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age between 30 and 75 years

• Fasting plasma glucose >= 100 mg/dl

• Triglyceride >= 150 mg/dl

• one of the criteria following

1. HDL <40 mg/dl in man or <50 mg/dl in woman

2. Blood pressure >= 135/85 mmHg or anti-hypertension drug treatment

3. Waist >90cm in man or 80cm in woman

• Signed the inform consent

Exclusion Criteria:

• Fasting plasma glucose > 180mg/dl

• Treated by more than two types oral hypoglycemic agents in past 3 months

• Treated continuously by anti-lipid agents for 3 months in past 6 months

• Treated by thiazolidinedione or digitalis at present

• Serum creatine > 2.5mg/dl

• Liver function (GOT or GPT) more than 3-fold upper limit

• Severe systemic disease by investigator's judgement

• Pregnant or nursing women

• Enrolled in other clinical study in recent 1 month

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Metamin 3D
Metamin 3D is composed by red yeast rice, bitter gourd, chlorella, soy peptide and licorice extract is a commercial product designed by Uni-President enterprises corp in Taiwan

Locations

Country	Name	City	State
Taiwan	Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital	Taichang

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cholesterol	To assess the change of total cholesterol between 0 and 12 weeks	12 weeks	No
Secondary	Total cholesterol	To assess the change of lipid profiles during study	4 and 8 weeks	No
Secondary	Triglycerides	To assess the change of lipid profiles during study	4 and 8 weeks	No
Secondary	Low-density lipoprotein cholesterol	LDL cholesterol: To assess the lipid profiles during study	4, 8 and 12 weeks	No
Secondary	The plasma insulin by meal tolerant test		4 and 8 weeks	No
Secondary	Glycosylated hemoglobin	HbA1c: To assess the glycemic control during the study period	4 and 8 weeks	No
Secondary	Fasting plasma glucose	withdrawal if fasting glucose greater than 250 mg/dl	4 and 8 weeks	Yes
Secondary	Systolic and diastolic blood pressure		4, 8 and 12 weeks	No
Secondary	Triglycerides	To assess the change of lipid profiles between 0 and 12 weeks	12 weeks	No
Secondary	The plasma glucose by meal tolerant test		12 weeks	No
Secondary	Glycosylated hemoglobin	To assess the change of HbA1c between 0 and 12 weeks	12 weeks	No
Secondary	Fasting plasma glucose	withdrawal if fasting glucose greater than 250 mg/dl	12 weeks	Yes
Secondary	Aspartate aminotransferase	GOT: To assess the liver functions at 0 and 12 weeks	12 weeks	Yes
Secondary	Alanine aminotransferase	GPT: To assess the liver functions at 0 and 12 weeks	12 weeks	Yes
Secondary	Creatinine	Serum creatinine: To assess the renal function at 0 and 12 weeks	12 weeks	Yes

External Links

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