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

Taichung Veterans General Hospital

Status and phase: Completed; Phase 3

Conditions: Metabolic Syndrome

Treatments: Drug: Metamin 3D

Study type: Interventional

Funder types: Other

Identifiers

NCT01120873

S06203

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 1 patient group

Metamin 3D

Experimental group

Description:

A randomized, double-blinded and placebo-controlled study

Treatment:

Drug: Metamin 3D