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

NCT01667224 | Completed Phase 2 Results DMC

• 1 other identifier: TgBio-TG1022-001
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

Actiponin; Obesity; Abdominal fat

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (3)

• Changes in Abdominal Total Fat Area.

  study visit 1(0 week), visit 4(12 week)

• Changes in Body Weight.

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

• Changes in Body Mss Index(BMI)

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

Study Arms (2)

Actiponin

EXPERIMENTAL

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

Dietary Supplement: Actiponin

Placebo

PLACEBO COMPARATOR

Placebo(450mg/day) for 12weeks

Dietary Supplement: Placebo

Interventions

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.

Also known as: Extract of Gynostemma pentaphyllum(450mg/day)

Actiponin

Placebo DIETARY_SUPPLEMENT

Amount and calorie of placebo are same with Actiponin.

Also known as: Placebo(450mg/day)

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥ 25kg/m2 and WHR ≥ 0.90(men), WHR ≥ 0.85(women)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

MeSH Terms

Conditions

Obesity

Interventions

gypenoside

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Soo-Wan Chae
• Organization: Clinical Trial Center for Functional Food in Chonbuk National University Hospital

soowan@jbnu.ac.kr

82-63-250-2348

Study Officials

• Soo-Wan Chae, Ph.D, MD

  Chonbuk National University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 17, 2012
• Study Start: October 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 23, 2017
• Results First Posted: April 21, 2014

Record last verified: 2017-01