Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811511
• Other study ID #: ORC-MS-CKJA
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 12, 2013
• Last updated: February 8, 2015
• Start date: March 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2015
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 29 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Dietary Supplement:
• Chungkookjang

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Obesity Research Center of Chonbuk National University	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Fat Mass	Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks	Yes
Primary	Changes in Percent Body Fat	Percent Body Fat was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks	Yes
Secondary	Change in Glucose	Glucose was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks	Yes
Secondary	Changes in Cholesterol	Cholesterol was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks	Yes