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

Chonbuk National University Hospital80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

ActiponinDIETARY_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.

PlaceboDIETARY_SUPPLEMENT

Amount and calorie of placebo are same with Actiponin.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changes in Body Fat Mass.

Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).

Time frame: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)

Secondary Outcomes

Changes in Abdominal Total Fat Area.

Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week).

Time frame: study visit 1(0 week), visit 4(12 week)

Changes in Body Weight.

Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).

Time frame: study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week)

Changes in Body Mss Index(BMI)

BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week).

Time frame: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.