Trial Outcomes & Findings for A Human Trial to Evaluate the Effects of Chungkookjang on Histamine-induced Wheal Size in Healthy Subjects (NCT NCT01402141)

NCT ID: NCT01402141

Last Updated: 2012-11-22

Results Overview

Histamine-induced wheal size was measured in study visit 1(0 week) and visit 3(12 week).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

60 participants

Primary outcome timeframe

12weeks

Results posted on

2012-11-22

Participant Flow

Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.

The criteria were an age from 19 to 80 years, Histamine skin prick test: above 3mm

Participant milestones

Participant milestones
Measure	Chungkookjang Chungkookjang(3times/day, 3packs/day, 35g/day) for 12weeks Chungkookjang: The Chungkookjang was manufactured from raw beans, peels made after freeze-drying	Placebo Placebo(3times/day, 3packs/day, 35g/day) for 12weeks Placebo : Amount and calorie of placebo are same with Chungkookjang.
Overall Study STARTED	30	30
Overall Study COMPLETED	29	28
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chungkookjang(35g) n=30 Participants	Placebo(35g) n=30 Participants	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	35.5 years STANDARD_DEVIATION 11.9 • n=5 Participants	34.2 years STANDARD_DEVIATION 12.9 • n=7 Participants	34.9 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	28 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment Korea, Republic of	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 12weeks

Population: per protocol analysis

Histamine-induced wheal size was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Chungkookjang n=29 Participants Oral intake Chungkookjang(35g) for 12weeks.	Placebo n=28 Participants Oral intake placebo(35g/day) for 12weeks
Changes in Histamine-induced Wheal Size Pre	14.9 mm^2 Standard Deviation 7.3	14.9 mm^2 Standard Deviation 7.0
Changes in Histamine-induced Wheal Size Post	14.1 mm^2 Standard Deviation 7.7	16.5 mm^2 Standard Deviation 5.8

PRIMARY outcome

Timeframe: 12weeks

Population: per protocol analysis

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.

Outcome measures

Outcome measures
Measure	Chungkookjang n=29 Participants Oral intake Chungkookjang(35g) for 12weeks.	Placebo n=28 Participants Oral intake placebo(35g/day) for 12weeks
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)	6 participants	1 participants

SECONDARY outcome

Timeframe: 12weeks

Population: per protocol analysis

Immunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Chungkookjang n=29 Participants Oral intake Chungkookjang(35g) for 12weeks.	Placebo n=28 Participants Oral intake placebo(35g/day) for 12weeks
Changes in Immunoglobulin E Pre	73.89 IU/mL Standard Deviation 92.38	69.32 IU/mL Standard Deviation 110.25
Changes in Immunoglobulin E Post	67.32 IU/mL Standard Deviation 81.74	62.72 IU/mL Standard Deviation 96.53

SECONDARY outcome

Timeframe: 12weeks

Population: per protocol analysis

Serum histamine was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Chungkookjang n=29 Participants Oral intake Chungkookjang(35g) for 12weeks.	Placebo n=28 Participants Oral intake placebo(35g/day) for 12weeks
Changes in Serum Histamine Pre	0.56 μg/g creatinine Standard Deviation 0.54	0.62 μg/g creatinine Standard Deviation 0.51
Changes in Serum Histamine Post	0.79 μg/g creatinine Standard Deviation 0.58	0.80 μg/g creatinine Standard Deviation 0.73

SECONDARY outcome

Timeframe: 12weeks

Population: per protocol analysis

Interferon-gamma was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Chungkookjang n=29 Participants Oral intake Chungkookjang(35g) for 12weeks.	Placebo n=28 Participants Oral intake placebo(35g/day) for 12weeks
Changes in Interferon-gamma Pre	14.56 IU/ml Standard Deviation 3.08	15.63 IU/ml Standard Deviation 5.46
Changes in Interferon-gamma Post	17.57 IU/ml Standard Deviation 1.87	18.06 IU/ml Standard Deviation 2.22

SECONDARY outcome

Timeframe: 12weeks

Population: per protocol analysis

Interleukin-4 was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Chungkookjang n=29 Participants Oral intake Chungkookjang(35g) for 12weeks.	Placebo n=28 Participants Oral intake placebo(35g/day) for 12weeks
Changes in Interleukin-4 Pre	0.78 pg/ml Standard Deviation 0.78	0.55 pg/ml Standard Deviation 1.56
Changes in Interleukin-4 Post	0.26 pg/ml Standard Deviation 0.20	0.35 pg/ml Standard Deviation 0.78

SECONDARY outcome

Timeframe: 12weeks

Population: per protocol analysis

Eosinophil was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Chungkookjang n=29 Participants Oral intake Chungkookjang(35g) for 12weeks.	Placebo n=28 Participants Oral intake placebo(35g/day) for 12weeks
Changes in Eosinophil Post	2.54 Percentage of WBCs(white blood cells) Standard Deviation 2.23	2.56 Percentage of WBCs(white blood cells) Standard Deviation 2.56
Changes in Eosinophil Pre	2.66 Percentage of WBCs(white blood cells) Standard Deviation 2.14	3.30 Percentage of WBCs(white blood cells) Standard Deviation 2.87

SECONDARY outcome

Timeframe: 12weeks

Population: per protocol analysis

Eosinophil Cationic Protein(ECP) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Chungkookjang n=29 Participants Oral intake Chungkookjang(35g) for 12weeks.	Placebo n=28 Participants Oral intake placebo(35g/day) for 12weeks
Changes in Eosinophil Cationic Protein(ECP) Pre	17.55 μg/L Standard Deviation 17.28	23.53 μg/L Standard Deviation 21.00
Changes in Eosinophil Cationic Protein(ECP) Post	19.09 μg/L Standard Deviation 17.49	21.80 μg/L Standard Deviation 26.10

Adverse Events

Chungkookjang(35g)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo(35g)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Baek-Hwan Cho, MD

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Phone: 82-63-250-1579

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place