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Efficacy and Safety of Red Ginseng on Decrement of Body Fat

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ClinicalTrials.gov Identifier: NCT01734005
Recruitment Status : Unknown
Verified November 2012 by Soo-Wan Chae, Chonbuk National University Hospital.
Recruitment status was:  Recruiting
First Posted : November 27, 2012
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Dietary Supplement: Red Ginseng Dietary Supplement: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : September 2012
Actual Primary Completion Date : September 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

Arm Intervention/treatment
Experimental: Red Ginseng Dietary Supplement: Red Ginseng
Red Ginseng (1.4g/day)

Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo (1.4g/day)




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

  2. Changes in Percent Body Fat [ Time Frame: 12 weeks ]
    Percent Body Fat was measured in study visit 1(0 week) and visit 3(12 week).


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

  2. Changes in BMI(body mass index) [ Time Frame: 12 weeks ]
    BMI(body mass index) was measured in study visit 1(0 week) and visit 3(12 week).



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012