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To evaluate the effect of Metamin 3D on improvement of glucose and lipid on Taiwanese subjects with metabolic syndrome.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metamin 3D | Experimental | A randomized, double-blinded and placebo-controlled study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metamin 3D | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol | To assess the change of total cholesterol between 0 and 12 weeks | 12 weeks |
| 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 |
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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
Signed the inform consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| I Te Lee, MD | Taichung Veterans General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital | Taichang | 407 | Taiwan |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D006943 | Hyperglycemia |
| D050171 | Dyslipidemias |
| D006973 | Hypertension |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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|
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |