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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Actiponin; Dietary Supplement: Placebo

• Registration Number: NCT01667224
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-08
• Study Completion: 2010-10
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Results First Submitted: 2014-03-16
• Results First Submitted QC: 2014-03-16
• Results First Posted: 2014-04-21
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Actiponin	Actiponin	Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks
Placebo	Placebo	Placebo(450mg/day) for 12weeks

Primary Outcome Measures

Name	Time	Method
Changes in Body Fat Mass.	study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)	Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).

Secondary Outcome Measures

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