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

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

Detailed Description
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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.

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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Dietary Supplement: Chungkookjang
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chungkookjang<br> | Dietary Supplement: Chungkookjang<br>* Chungkookjang(35g/say)for 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo(35g/day) for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Histamine-induced Wheal Size | Histamine-induced wheal size was measured in study visit 1(0 week) and visit 3(12 week). | 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) | 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. | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Immunoglobulin E | Immunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks | 
| Changes in Serum Histamine | Serum histamine was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks | 
| Changes in Interferon-gamma | Interferon-gamma was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks | 
| Changes in Interleukin-4 | Interleukin-4 was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks | 
| Changes in Eosinophil | Eosinophil was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks | 
| Changes in Eosinophil Cationic Protein(ECP) | Eosinophil Cationic Protein(ECP) was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chungkookjang, histamine, skin reaction, wheal