Efficacy and Safety of Actiponin on Antiobesity in Obese Korean Subjects. - Full Text View

Purpose

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.

Condition	Intervention	Phase
Obesity	Dietary Supplement: Actiponin Dietary Supplement: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Actiponin Supplementation Reduces Abdominal Fat Area, Weight, Body Fat Mass and BMI in Obese Korean Subjects.

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:

Changes in body fat mass and abdominal fat area. [ Time Frame: 12week ] [ Designated as safety issue: Yes ]
Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).

Abdominal fat area was measured in study visit 1(0 week) and visit 3(12 week).

Secondary Outcome Measures:

Changes in anthropometric parameters(weight, BMI, waist and hip circumference etc.). [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
Anthropometric parameters(weight, body mass index, percent body fat, lean body mass) were measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).
Changes in blood lipid profile(Total cholestero, triglyceride, HDL-choelstero, LDL-choletero, Apolipoprotein-A1, Apolipoprotein-B, Free fatty acid) [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
Blood lipid profile(total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, free fatty acid, apolipoprotein A1, apolipoprotein B) were measured in study visit 1(as screening test), visit 3(8 week) and visit 4(12 week).

Enrollment:	80
Study Start Date:	October 2009
Study Completion Date:	October 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: Placebo(450mg/day)

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.

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667224

Sponsors and Collaborators

Chonbuk National University Hospital

Investigators

Study Chair:

Soo-Wan Chae, Ph.D, MD

Chonbuk National University Hospital

More Information

No publications provided

Responsible Party:	Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:	NCT01667224 History of Changes
Other Study ID Numbers:	TgBio-TG1022-001
Study First Received:	August 14, 2012
Last Updated:	August 15, 2012
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Chonbuk National University Hospital:

Actiponin
Obesity
Abdominal fat

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013