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

Efficacy and Safety of Chungkookjang, a Fermented Soy Paste, on Histamine-induced Wheal Size

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01402141
Enrollment
60
Registered
2011-07-26
Start date
2010-10-31
Completion date
2011-09-30
Last updated
2012-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

Chungkookjang, histamine, skin reaction, wheal

Brief summary

The investigators investigate the effect of Chungkookjang on histamine-induced skin reaction in a double-blind, randomized, placebo-controlled, human trial

Detailed description

Sixty volunteers (aged 20-80) who gave a written consent before entering the study, were randomized in two groups of thirty subjects each. The skin prick test with histamine was performed on the ventral forearm, 10 cm from the elbow, before and after supplement administration, as well as three times daily for 12 weeks of chungkookjang(35g/day) or placebo(35g/day)intake.

Interventions

DIETARY_SUPPLEMENTChungkookjang

Chungkookjang(35g/say)for 12 weeks

DIETARY_SUPPLEMENTPlacebo

Placebo(35g/day) for 12 weeks

Sponsors

Chonbuk National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Histamine skin prick test: above 3mm

Exclusion criteria

* No medication or cosmetic creams were allowed during Substances the previous week and no drugs containing corticosteroids or ACTH within 3 months. * Patients on systemic or topical treatment with immunosuppressive agents on the nondominant arm were excluded

Design outcomes

Primary

MeasureTime frameDescription
Changes in Histamine-induced Wheal Size12weeksHistamine-induced wheal size was measured in study visit 1(0 week) and visit 3(12 week).
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)12weeksNumber 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.

Secondary

MeasureTime frameDescription
Changes in Interferon-gamma12weeksInterferon-gamma was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Interleukin-412weeksInterleukin-4 was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Immunoglobulin E12weeksImmunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Eosinophil Cationic Protein(ECP)12weeksEosinophil Cationic Protein(ECP) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Eosinophil12weeksEosinophil was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Serum Histamine12weeksSerum histamine was measured in study visit 1(0 week) and visit 3(12 week).

Countries

South Korea

Participant flow

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

Participants by arm

ArmCount
Chungkookjang(35g)30
Placebo(35g)30
Total60

Baseline characteristics

CharacteristicPlacebo(35g)Chungkookjang(35g)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
30 Participants30 Participants60 Participants
Age Continuous34.2 years
STANDARD_DEVIATION 12.9
35.5 years
STANDARD_DEVIATION 11.9
34.9 years
STANDARD_DEVIATION 12.3
Region of Enrollment
Korea, Republic of
30 participants30 participants60 participants
Sex: Female, Male
Female
28 Participants20 Participants48 Participants
Sex: Female, Male
Male
2 Participants10 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Changes in Histamine-induced Wheal Size

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

Time frame: 12weeks

Population: per protocol analysis

ArmMeasureGroupValue (MEAN)Dispersion
ChungkookjangChanges in Histamine-induced Wheal SizePre14.9 mm^2Standard Deviation 7.3
ChungkookjangChanges in Histamine-induced Wheal SizePost14.1 mm^2Standard Deviation 7.7
PlaceboChanges in Histamine-induced Wheal SizePre14.9 mm^2Standard Deviation 7
PlaceboChanges in Histamine-induced Wheal SizePost16.5 mm^2Standard Deviation 5.8
Primary

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)

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

Population: per protocol analysis

ArmMeasureValue (NUMBER)
ChungkookjangNumber 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
PlaceboNumber 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)1 participants
Secondary

Changes in Eosinophil

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

Time frame: 12weeks

Population: per protocol analysis

ArmMeasureGroupValue (MEAN)Dispersion
ChungkookjangChanges in EosinophilPre2.66 Percentage of WBCs(white blood cells)Standard Deviation 2.14
ChungkookjangChanges in EosinophilPost2.54 Percentage of WBCs(white blood cells)Standard Deviation 2.23
PlaceboChanges in EosinophilPre3.30 Percentage of WBCs(white blood cells)Standard Deviation 2.87
PlaceboChanges in EosinophilPost2.56 Percentage of WBCs(white blood cells)Standard Deviation 2.56
Secondary

Changes in Eosinophil Cationic Protein(ECP)

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

Time frame: 12weeks

Population: per protocol analysis

ArmMeasureGroupValue (MEAN)Dispersion
ChungkookjangChanges in Eosinophil Cationic Protein(ECP)Pre17.55 μg/LStandard Deviation 17.28
ChungkookjangChanges in Eosinophil Cationic Protein(ECP)Post19.09 μg/LStandard Deviation 17.49
PlaceboChanges in Eosinophil Cationic Protein(ECP)Pre23.53 μg/LStandard Deviation 21
PlaceboChanges in Eosinophil Cationic Protein(ECP)Post21.80 μg/LStandard Deviation 26.1
Secondary

Changes in Immunoglobulin E

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

Time frame: 12weeks

Population: per protocol analysis

ArmMeasureGroupValue (MEAN)Dispersion
ChungkookjangChanges in Immunoglobulin EPre73.89 IU/mLStandard Deviation 92.38
ChungkookjangChanges in Immunoglobulin EPost67.32 IU/mLStandard Deviation 81.74
PlaceboChanges in Immunoglobulin EPre69.32 IU/mLStandard Deviation 110.25
PlaceboChanges in Immunoglobulin EPost62.72 IU/mLStandard Deviation 96.53
Secondary

Changes in Interferon-gamma

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

Time frame: 12weeks

Population: per protocol analysis

ArmMeasureGroupValue (MEAN)Dispersion
ChungkookjangChanges in Interferon-gammaPre14.56 IU/mlStandard Deviation 3.08
ChungkookjangChanges in Interferon-gammaPost17.57 IU/mlStandard Deviation 1.87
PlaceboChanges in Interferon-gammaPre15.63 IU/mlStandard Deviation 5.46
PlaceboChanges in Interferon-gammaPost18.06 IU/mlStandard Deviation 2.22
Secondary

Changes in Interleukin-4

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

Time frame: 12weeks

Population: per protocol analysis

ArmMeasureGroupValue (MEAN)Dispersion
ChungkookjangChanges in Interleukin-4Pre0.78 pg/mlStandard Deviation 0.78
ChungkookjangChanges in Interleukin-4Post0.26 pg/mlStandard Deviation 0.2
PlaceboChanges in Interleukin-4Pre0.55 pg/mlStandard Deviation 1.56
PlaceboChanges in Interleukin-4Post0.35 pg/mlStandard Deviation 0.78
Secondary

Changes in Serum Histamine

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

Time frame: 12weeks

Population: per protocol analysis

ArmMeasureGroupValue (MEAN)Dispersion
ChungkookjangChanges in Serum HistaminePre0.56 μg/g creatinineStandard Deviation 0.54
ChungkookjangChanges in Serum HistaminePost0.79 μg/g creatinineStandard Deviation 0.58
PlaceboChanges in Serum HistaminePre0.62 μg/g creatinineStandard Deviation 0.51
PlaceboChanges in Serum HistaminePost0.80 μg/g creatinineStandard Deviation 0.73

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026