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A Human Trial to Evaluate the Effects of Chungkookjang on Histamine-induced Wheal Size in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01402141
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : November 12, 2012
Last Update Posted : November 22, 2012
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Healthy Subjects
Interventions Dietary Supplement: Chungkookjang
Dietary Supplement: Placebo
Enrollment 60
Recruitment Details Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
Pre-assignment Details The criteria were an age from 19 to 80 years, Histamine skin prick test: above 3mm
Arm/Group Title Chungkookjang Placebo
Hide Arm/Group Description

Chungkookjang(3times/day, 3packs/day, 35g/day) for 12weeks

Chungkookjang: The Chungkookjang was manufactured from raw beans, peels made after freeze-drying

Placebo(3times/day, 3packs/day, 35g/day) for 12weeks

Placebo : Amount and calorie of placebo are same with Chungkookjang.

Period Title: Overall Study
Started 30 30
Completed 29 28
Not Completed 1 2
Arm/Group Title Chungkookjang(35g) Placebo(35g) Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
30
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
35.5  (11.9) 34.2  (12.9) 34.9  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
20
  66.7%
28
  93.3%
48
  80.0%
Male
10
  33.3%
2
   6.7%
12
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Changes in Histamine-induced Wheal Size
Hide Description Histamine-induced wheal size was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Chungkookjang Placebo
Hide Arm/Group Description:
Oral intake Chungkookjang(35g) for 12weeks.
Oral intake placebo(35g/day) for 12weeks
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: mm^2
Pre 14.9  (7.3) 14.9  (7.0)
Post 14.1  (7.7) 16.5  (5.8)
2.Primary Outcome
Title Number of Participants With Greater Than 40% Decrease in Histamine-induced Wheal Size (Wheal Size by More Than 40% Decrease in the Number of Subjects Compared With Placebo)
Hide Description

Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size was measured in study visit 1(0 week) and visit 3(12 week).

Percentage change in histamine-induced wheal size calculations were calculated by the formula ((12weeks - 0weeks) * 100/0weeks).

Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size compared with placebo.

Time Frame 12weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Chungkookjang Placebo
Hide Arm/Group Description:
Oral intake Chungkookjang(35g) for 12weeks.
Oral intake placebo(35g/day) for 12weeks
Overall Number of Participants Analyzed 29 28
Measure Type: Number
Unit of Measure: participants
6 1
3.Secondary Outcome
Title Changes in Immunoglobulin E
Hide Description Immunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Chungkookjang Placebo
Hide Arm/Group Description:
Oral intake Chungkookjang(35g) for 12weeks.
Oral intake placebo(35g/day) for 12weeks
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: IU/mL
Pre 73.89  (92.38) 69.32  (110.25)
Post 67.32  (81.74) 62.72  (96.53)
4.Secondary Outcome
Title Changes in Serum Histamine
Hide Description Serum histamine was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Chungkookjang Placebo
Hide Arm/Group Description:
Oral intake Chungkookjang(35g) for 12weeks.
Oral intake placebo(35g/day) for 12weeks
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: μg/g creatinine
Pre 0.56  (0.54) 0.62  (0.51)
Post 0.79  (0.58) 0.80  (0.73)
5.Secondary Outcome
Title Changes in Interferon-gamma
Hide Description Interferon-gamma was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Chungkookjang Placebo
Hide Arm/Group Description:
Oral intake Chungkookjang(35g) for 12weeks.
Oral intake placebo(35g/day) for 12weeks
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: IU/ml
Pre 14.56  (3.08) 15.63  (5.46)
Post 17.57  (1.87) 18.06  (2.22)
6.Secondary Outcome
Title Changes in Interleukin-4
Hide Description Interleukin-4 was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Chungkookjang Placebo
Hide Arm/Group Description:
Oral intake Chungkookjang(35g) for 12weeks.
Oral intake placebo(35g/day) for 12weeks
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: pg/ml
Pre 0.78  (0.78) 0.55  (1.56)
Post 0.26  (0.20) 0.35  (0.78)
7.Secondary Outcome
Title Changes in Eosinophil
Hide Description Eosinophil was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Chungkookjang Placebo
Hide Arm/Group Description:
Oral intake Chungkookjang(35g) for 12weeks.
Oral intake placebo(35g/day) for 12weeks
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: Percentage of WBCs(white blood cells)
Pre 2.66  (2.14) 3.30  (2.87)
Post 2.54  (2.23) 2.56  (2.56)
8.Secondary Outcome
Title Changes in Eosinophil Cationic Protein(ECP)
Hide Description Eosinophil Cationic Protein(ECP) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Chungkookjang Placeb
Hide Arm/Group Description:
Oral intake Chungkookjang(35g) for 12weeks.
Oral intake placebo(35g/day) for 12weeks
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: μg/L
Pre 17.55  (17.28) 23.53  (21.00)
Post 19.09  (17.49) 21.80  (26.10)
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and/or other [non-serious] adverse events were not collected/assessed
 
Arm/Group Title Chungkookjang(35g) Placebo(35g)
Hide Arm/Group Description Oral intake Chungkookjang(35g) for 12weeks. Oral intake placebo(35g/day) for 12weeks
All-Cause Mortality
Chungkookjang(35g) Placebo(35g)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Chungkookjang(35g) Placebo(35g)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chungkookjang(35g) Placebo(35g)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Baek-Hwan Cho, MD
Organization: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Phone: 82-63-250-1579
Responsible Party: Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01402141     History of Changes
Other Study ID Numbers: SunChang-TCKJ-001
First Submitted: July 21, 2011
First Posted: July 26, 2011
Results First Submitted: July 11, 2012
Results First Posted: November 12, 2012
Last Update Posted: November 22, 2012