Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome

Chonbuk National University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Chungkookjang

Study type: Interventional

Funder types: Other

Identifiers

NCT01811511

ORC-MS-CKJA

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

120 participants in 2 patient groups, including a placebo group

Chungkookjang

Experimental group

Description:

Chungkookjang(35g/day)

Treatment:

Dietary Supplement: Chungkookjang

Dietary Supplement: Placebo

Placebo

Placebo Comparator group

Description:

Placebo(35g/day)

Treatment:

Dietary Supplement: Chungkookjang

Dietary Supplement: Placebo