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OpenTrials
Completed

NCT Number: NCT01667224

Efficacy and Safety of Actiponin on Antiobesity 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Actiponin

Dietary Supplement

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

Dietary Supplement

Amount and calorie of placebo are same with Actiponin.

Other names: Placebo(450mg/day)

Primary outcomes

  1. Changes in Body Fat Mass.

    Time frame: 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 outcomes

  1. Changes in Abdominal Total Fat Area.

    Time frame: 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).

  2. Changes in Body Weight.

    Time frame: 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).

  3. Changes in Body Mss Index(BMI)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 17, 2012
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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