NCT01811511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

10 months

First QC Date

March 12, 2013

Last Update Submit

February 8, 2015

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

  • Change in Body Fat Mass

    Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).

    12 weeks

  • Changes in Percent Body Fat

    Percent Body Fat was measured in study visit 1(0 week) and visit 3(12 week).

    12 weeks

Secondary Outcomes (2)

  • Change in Glucose

    12 weeks

  • Changes in Cholesterol

    12 weeks

Study Arms (2)

Chungkookjang

EXPERIMENTAL

Chungkookjang(35g/day)

Dietary Supplement: ChungkookjangDietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR

Placebo(35g/day)

Dietary Supplement: ChungkookjangDietary Supplement: Placebo

Interventions

ChungkookjangDIETARY_SUPPLEMENT
Also known as: Chungkookjang(35g/day)
ChungkookjangPlacebo
PlaceboDIETARY_SUPPLEMENT
Also known as: Placebo(35g/day)
ChungkookjangPlacebo

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obesity Research Center of Chonbuk National University

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 27302672DERIVED

  • 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.

    PMID: 24171779DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

chungkookjang

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obesity Research Center of Chonbuk National University

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 14, 2013

Study Start

March 1, 2013

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations

KR(1)