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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Actiponin; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Actiponin; Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks	Dietary supplement: Actiponin; 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.; Other Names: Extract of Gynostemma pentaphyllum(450mg/day)
Placebo Comparator: Placebo; Placebo(450mg/day) for 12weeks	Dietary supplement: Placebo; Amount and calorie of placebo are same with Actiponin.; Other Names: Placebo(450mg/day)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital
• Investigators: Study Chair: Soo-Wan Chae, Ph.D, MD, Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: August 14, 2012
• First Submitted That Met QC Criteria: August 15, 2012
• First Posted (Estimate): August 17, 2012

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: January 5, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Abdominal fat; Actiponin
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: TgBio-TG1022-001