Efficacy and Safety of Actiponin on Antiobesity in Obese Korean Subjects.

Study Overview
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Brief Summary
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Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year. In vitro and animal studies elucidated Actiponin as a novel anti-obesity agent. However, the efficacy and safety of Actiponin supplementation on body weight regulation in humans are lacking.

Detailed Description
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The primary aim of the study was to investigate the effect of Actiponin in Korean subjects on body weight and fat loss along with changes in metabolic markers based on 12 week, randomized, double-blind, placebo-controlled clinical trial. Eighty obesity subjects with BMI > 25kg/m2 and waist-hip ratio (WHR) ≥ 0.90 for men and ≥ 0.85 for women were randomly divided into either Actiponin (n=40, 450mg/day) or placebo group (n=40, 450mg/day) for 12weeks.

Official Title
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Actiponin Supplementation Reduces Abdominal Fat Area, Weight, Body Fat Mass and BMI in Obese Korean Subjects.

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Actiponin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 25kg/m2 and WHR ≥ 0.90(men), WHR ≥ 0.85(women) Exclusion Criteria: Significant variation in weight(more 10%) in the past 3 months Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker History of disease that could interfere with the test products or impede theire absorption, such as gastrointestinal disease or gastrointestinal surgery Participation in any other clinical trials within past 2 months Abdominal hepatic liver function Renal disease, e.g. acute/chronic renal failure, nephritic syndrome Used antipsychosis drugs therapy within past 2 months Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnancy or breast feeding History of alcohol or substance abuse Allergic or hypersensitive to any of the ingredients in the test products

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Actiponin<br>Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks | Dietary Supplement: Actiponin<br>* The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.<br>* Other names: Extract of Gynostemma pentaphyllum(450mg/day);|
| Placebo Comparator: Placebo<br>Placebo(450mg/day) for 12weeks | Dietary Supplement: Placebo<br>* Amount and calorie of placebo are same with Actiponin.<br>* Other names: Placebo(450mg/day);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Body Fat Mass. | Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week). | study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Abdominal Total Fat Area. | Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week). | study visit 1(0 week), visit 4(12 week) | 
| Changes in Body Weight. | Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week). | study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week) | 
| Changes in Body Mss Index(BMI) | BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week). | study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Actiponin, Abdominal fat