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Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT01811511
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Tae Sun Park, Chonbuk National University Hospital

Brief Summary:
The investigators performed a 12-week, randomized, double-blind, placebo-controlled crossover human trial to evaluate the efficacy and safety of chungkookjang on improvement of metabolic syndrome. The investigators measured decrement of body fat parameters, including Body Fat Mass, Percent Body Fat, Fat Free Mass, Weight and BMI(body mass index), and monitored their blood pressure.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Chungkookjang Dietary Supplement: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : March 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chungkookjang
Chungkookjang(35g/day)
Dietary Supplement: Chungkookjang
Other Name: Chungkookjang(35g/day)

Dietary Supplement: Placebo
Other Name: Placebo(35g/day)

Placebo Comparator: Placebo
Placebo(35g/day)
Dietary Supplement: Chungkookjang
Other Name: Chungkookjang(35g/day)

Dietary Supplement: Placebo
Other Name: Placebo(35g/day)




Primary Outcome Measures :
  1. Change 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. Change in Glucose [ Time Frame: 12 weeks ]
    Glucose was measured in study visit 1(0 week) and visit 3(12 week).

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



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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females 18-29 years old
  • BMI(body mass index) ≥ 23 kg/m2 or WC(Waist Circumference) ≥ 90(men), WC(Waist Circumference) ≥ 85(women)
  • Able to give informed consent

Exclusion Criteria:

  • Allergic or hypersensitive to any of the ingredients in the test products
  • The diagnosis of type 1 and type 2 diabetes or fasting glucose ≥ 126mg/dL
  • Systolic pressure ≥ 160mmHg, diastolic pressure ≥ 100mmHg
  • 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

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): NCT01811511


Locations
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Korea, Republic of
Obesity Research Center of Chonbuk National University
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tae Sun Park, Obesity Research Center of Chonbuk National University, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01811511     History of Changes
Other Study ID Numbers: ORC-MS-CKJA
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases