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

This study has been completed.
Sponsor:
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01120873
First received: May 5, 2010
Last updated: May 10, 2010
Last verified: May 2010

May 5, 2010
May 10, 2010
March 2007
June 2009   (final data collection date for primary outcome measure)
Total cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To assess the change of total cholesterol between 0 and 12 weeks
Same as current
Complete list of historical versions of study NCT01120873 on ClinicalTrials.gov Archive Site
  • Total cholesterol [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
    To assess the change of lipid profiles during study
  • Triglycerides [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
    To assess the change of lipid profiles during study
  • Low-density lipoprotein cholesterol [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]

    LDL cholesterol:

    To assess the lipid profiles during study

  • The plasma insulin by meal tolerant test [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Glycosylated hemoglobin [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]

    HbA1c:

    To assess the glycemic control during the study period

  • Fasting plasma glucose [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
    withdrawal if fasting glucose greater than 250 mg/dl
  • Systolic and diastolic blood pressure [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To assess the change of lipid profiles between 0 and 12 weeks
  • The plasma glucose by meal tolerant test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Glycosylated hemoglobin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To assess the change of HbA1c between 0 and 12 weeks
  • Fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    withdrawal if fasting glucose greater than 250 mg/dl
  • Aspartate aminotransferase [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    GOT:

    To assess the liver functions at 0 and 12 weeks

  • Alanine aminotransferase [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    GPT:

    To assess the liver functions at 0 and 12 weeks

  • Creatinine [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    Serum creatinine:

    To assess the renal function at 0 and 12 weeks

Same as current
Not Provided
Not Provided
 
The Effect of Metamin 3D on the Lipid and Glucose in Subjects With Metabolic Syndrome
Phase 3 Study of 3D in Metabolic Syndrome

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Metabolic Syndrome
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
Other Name: 3D
Experimental: Metamin 3D
A randomized, double-blinded and placebo-controlled study
Intervention: Drug: Metamin 3D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01120873
S06203
No
I-Te, Lee, Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital
Taichung Veterans General Hospital
Not Provided
Principal Investigator: I Te Lee, MD Taichung Veterans General Hospital, Taichung
Taichung Veterans General Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP