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Completed

NCT Number: NCT01120873

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

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

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Key information

Conditions

Metabolic Syndrome Body Weight Cardiovascular Diseases Dyslipidemias Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Hypertension Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital

Taichang, 407, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: 3D

Primary outcomes

  1. Total cholesterol

    Time frame: 12 weeks

    To assess the change of total cholesterol between 0 and 12 weeks

Secondary outcomes

  1. Total cholesterol

    Time frame: 4 and 8 weeks

    To assess the change of lipid profiles during study

  2. Triglycerides

    Time frame: 4 and 8 weeks

    To assess the change of lipid profiles during study

  3. Low-density lipoprotein cholesterol

    Time frame: 4, 8 and 12 weeks

    LDL cholesterol:

    To assess the lipid profiles during study

  4. The plasma insulin by meal tolerant test

    Time frame: 4 and 8 weeks

  5. Glycosylated hemoglobin

    Time frame: 4 and 8 weeks

    HbA1c:

    To assess the glycemic control during the study period

  6. Fasting plasma glucose

    Time frame: 4 and 8 weeks

    withdrawal if fasting glucose greater than 250 mg/dl

  7. Systolic and diastolic blood pressure

    Time frame: 4, 8 and 12 weeks

  8. Triglycerides

    Time frame: 12 weeks

    To assess the change of lipid profiles between 0 and 12 weeks

  9. The plasma glucose by meal tolerant test

    Time frame: 12 weeks

  10. Glycosylated hemoglobin

    Time frame: 12 weeks

    To assess the change of HbA1c between 0 and 12 weeks

  11. Fasting plasma glucose

    Time frame: 12 weeks

    withdrawal if fasting glucose greater than 250 mg/dl

  12. Aspartate aminotransferase

    Time frame: 12 weeks

    GOT:

    To assess the liver functions at 0 and 12 weeks

  13. Alanine aminotransferase

    Time frame: 12 weeks

    GPT:

    To assess the liver functions at 0 and 12 weeks

  14. Creatinine

    Time frame: 12 weeks

    Serum creatinine:

    To assess the renal function at 0 and 12 weeks

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

Phase 3 Study of 3D in Metabolic Syndrome

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 11, 2010
Registry last updated
May 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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