Metabolic Syndrome
Conditions
Keywords
Hyperglycemia, dyslipidemia, Hypertension, Obesity
Brief summary
To evaluate the effect of Metamin 3D on improvement of glucose and lipid on Taiwanese subjects with metabolic syndrome.
Detailed 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.
Interventions
DRUGMetamin 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
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total cholesterol | 12 weeks | To assess the change of total cholesterol between 0 and 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Triglycerides | 4 and 8 weeks | To assess the change of lipid profiles during study |
| Low-density lipoprotein cholesterol | 4, 8 and 12 weeks | LDL cholesterol: To assess the lipid profiles during study |
| The plasma insulin by meal tolerant test | 4 and 8 weeks | — |
| Glycosylated hemoglobin | 4 and 8 weeks | HbA1c: To assess the glycemic control during the study period |
| Fasting plasma glucose | 4 and 8 weeks | withdrawal if fasting glucose greater than 250 mg/dl |
| Total cholesterol | 4 and 8 weeks | To assess the change of lipid profiles during study |
| The plasma glucose by meal tolerant test | 12 weeks | — |
| Aspartate aminotransferase | 12 weeks | GOT: To assess the liver functions at 0 and 12 weeks |
| Alanine aminotransferase | 12 weeks | GPT: To assess the liver functions at 0 and 12 weeks |
| Creatinine | 12 weeks | Serum creatinine: To assess the renal function at 0 and 12 weeks |
| Systolic and diastolic blood pressure | 4, 8 and 12 weeks | — |
Countries
Taiwan
Outcome results
None listed