Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome

NCT ID: NCT01811511

Last Updated: 2015-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Chungkookjang

Chungkookjang(35g/day)

Group Type EXPERIMENTAL

Chungkookjang

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo(35g/day)

Group Type PLACEBO_COMPARATOR

Chungkookjang

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Chungkookjang

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Chungkookjang(35g/day) Placebo(35g/day)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tae Sun Park

Obesity Research Center of Chonbuk National University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Obesity Research Center of Chonbuk National University

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

References

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Byun MS, Yu OK, Cha YS, Park TS. Korean traditional Chungkookjang improves body composition, lipid profiles and atherogenic indices in overweight/obese subjects: a double-blind, randomized, crossover, placebo-controlled clinical trial. Eur J Clin Nutr. 2016 Oct;70(10):1116-1122. doi: 10.1038/ejcn.2016.77. Epub 2016 Jun 15.

Reference Type DERIVED
PMID: 27302672 (View on PubMed)

Back HI, Ha KC, Kim HM, Kim MG, Yu OK, Byun MS, Jeong DY, Jeong SY, Cha YS, Park TS. The influence of the Korean traditional Chungkookjang on variables of metabolic syndrome in overweight/obese subjects: study protocol. BMC Complement Altern Med. 2013 Oct 31;13:297. doi: 10.1186/1472-6882-13-297.

Reference Type DERIVED
PMID: 24171779 (View on PubMed)

Other Identifiers

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ORC-MS-CKJA

Identifier Type: -

Identifier Source: org_study_id

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