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

Chonbuk National University

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Dietary Supplement: Actiponin; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01667224

TgBio-TG1022-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups, including a placebo group

Actiponin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Actiponin

Placebo

Placebo Comparator group

Description:

Placebo(450mg/day) for 12weeks

Treatment:

Dietary Supplement: Placebo