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

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

Detailed Description
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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.

Official Title
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Phase 3 Study of 3D in Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Drug: Metamin 3D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 30 and 75 years Fasting plasma glucose >= 100 mg/dl Triglyceride >= 150 mg/dl one of the criteria following HDL <40 mg/dl in man or <50 mg/dl in woman Blood pressure >= 135/85 mmHg or anti-hypertension drug treatment 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metamin 3D<br>A randomized, double-blinded and placebo-controlled study | Drug: Metamin 3D<br>* 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<br>* Other names: 3D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol | To assess the change of total cholesterol between 0 and 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol | To assess the change of lipid profiles during study | 4 and 8 weeks | 
| Triglycerides | To assess the change of lipid profiles during study | 4 and 8 weeks | 
| Low-density lipoprotein cholesterol | LDL cholesterol: To assess the lipid profiles during study | 4, 8 and 12 weeks | 
| The plasma insulin by meal tolerant test |  | 4 and 8 weeks | 
| Glycosylated hemoglobin | HbA1c: To assess the glycemic control during the study period | 4 and 8 weeks | 
| Fasting plasma glucose | withdrawal if fasting glucose greater than 250 mg/dl | 4 and 8 weeks | 
| Systolic and diastolic blood pressure |  | 4, 8 and 12 weeks | 
| Triglycerides | To assess the change of lipid profiles between 0 and 12 weeks | 12 weeks | 
| The plasma glucose by meal tolerant test |  | 12 weeks | 
| Glycosylated hemoglobin | To assess the change of HbA1c between 0 and 12 weeks | 12 weeks | 
| Fasting plasma glucose | withdrawal if fasting glucose greater than 250 mg/dl | 12 weeks | 
| Aspartate aminotransferase | GOT: To assess the liver functions at 0 and 12 weeks | 12 weeks | 
| Alanine aminotransferase | GPT: To assess the liver functions at 0 and 12 weeks | 12 weeks | 
| Creatinine | Serum creatinine: To assess the renal function at 0 and 12 weeks | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperglycemia, dyslipidemia, Hypertension, Obesity