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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01667224
First received: August 14, 2012
Last updated: March 16, 2014
Last verified: March 2014
  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:


Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in Body Fat Mass. [ 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).


Secondary Outcome Measures:
  • Changes in Abdominal Total Fat Area. [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
    Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week).

  • Changes in Body Weight. [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
    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 Body Mss Index(BMI) [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
    BMI was measured in study visit 1 (0 week), visit 2 (4 week), 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: March 16, 2014
Last Updated: March 16, 2014
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 July 24, 2014