Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome

Phase 2

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Chungkookjang; Dietary Supplement: Placebo

• Registration Number: NCT01811511
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-14
• Primary Completion: 2014-01
• Study Completion: 2014-02
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-08
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Chungkookjang	Placebo	Chungkookjang(35g/day)
Placebo	Placebo	Placebo(35g/day)
Placebo	Chungkookjang	Placebo(35g/day)
Chungkookjang	Chungkookjang	Chungkookjang(35g/day)

Primary Outcome Measures

Name	Time	Method
Change in Body Fat Mass	12 weeks	Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Percent Body Fat	12 weeks	Percent Body Fat was measured in study visit 1(0 week) and visit 3(12 week).

Secondary Outcome Measures

Name	Time	Method
Changes in Cholesterol	12 weeks	Cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Change in Glucose	12 weeks	Glucose was measured in study visit 1(0 week) and visit 3(12 week).

Trial Locations

Locations (1)

Obesity Research Center of Chonbuk National University; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of