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

Phase 2

Completed

• Conditions: Healthy Subjects
• Interventions: Dietary Supplement: Chungkookjang; Dietary Supplement: Placebo

• Registration Number: NCT01402141
• Lead Sponsor: Chonbuk National University Hospital

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.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-07
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Study Completion: 2011-09
• Results First Submitted: 2012-07-11
• Results First Submitted QC: 2012-10-11
• Status Verified: 2012-11
• Results First Posted: 2012-11-12
• Last Update Submitted: 2012-11-21
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chungkookjang	Chungkookjang	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes in Histamine-induced Wheal Size	12weeks	Histamine-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)	12weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of