Efficacy and Safety of Red Ginseng on Decrement of Body Fat

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Chonbuk National University Hospital
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01734005
First received: November 21, 2012
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of red ginseng on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.


Condition Intervention Phase
Obesity
Dietary Supplement: Red Ginseng
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in Body Fat Mass [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in Percent Body Fat [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Percent Body Fat was measured in study visit 1(0 week) and visit 3(12 week).


Secondary Outcome Measures:
  • Changes in weight [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Weight was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in BMI(body mass index) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    BMI(body mass index) was measured in study visit 1(0 week) and visit 3(12 week).


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: March 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Red Ginseng Dietary Supplement: Red Ginseng
Red Ginseng (1.4g/day)
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo (1.4g/day)

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females 19-65 years old
  • BMI(body mass index) ≥ 25 kg/m^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)
  • Able to give informed consent

Exclusion Criteria:

  • Significant variation in weight(more 10%) in the past 3 months
  • Allergic or hypersensitive to any of the ingredients in the test products
  • History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
  • History of alcohol or substance abuse
  • Participation in any other clinical trials within past 2 months
  • Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
  • Pregnant or lactating women etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734005

Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Contact: Soo-Wan Chae, MD., PhD    82-63-250-2539    soowan@jbnu.ac.kr   
Sponsors and Collaborators
Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01734005     History of Changes
Other Study ID Numbers: ARIMED-BF-GC
Study First Received: November 21, 2012
Last Updated: November 26, 2012
Health Authority: South Korea: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014