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

NCT ID: NCT01120873

Last Updated: 2010-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Metamin 3D

A randomized, double-blinded and placebo-controlled study

Group Type EXPERIMENTAL

Metamin 3D

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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3D

Eligibility Criteria

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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

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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

Principal Investigators

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I Te Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital, Taichung

Locations

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

Taichang, , Taiwan

Site Status

Countries

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Taiwan

Related Links

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Other Identifiers

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S06203

Identifier Type: -

Identifier Source: org_study_id

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