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

NCT ID: NCT01667224

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-10-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Actiponin

Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks

Group Type: EXPERIMENTAL

Actiponin

Intervention Type: 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.

Placebo

Placebo(450mg/day) for 12weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Amount and calorie of placebo are same with Actiponin.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Amount and calorie of placebo are same with Actiponin.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Extract of Gynostemma pentaphyllum(450mg/day); Placebo(450mg/day)

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo-Wan Chae

Clinical Trial Center for Functional Foods

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soo-Wan Chae, Ph.D, MD

Role: STUDY_CHAIR

Chonbuk National University Hospital

Other Identifiers

TgBio-TG1022-001

Identifier Type: -

Identifier Source: org_study_id