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

Chonbuk National University Hospital60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Healthy Subjects

Interventions

ChungkookjangDIETARY_SUPPLEMENT

Chungkookjang(35g/say)for 12 weeks

PlaceboDIETARY_SUPPLEMENT

Placebo(35g/day) for 12 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Changes in Immunoglobulin E

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

Time frame: 12weeks

Changes in Serum Histamine

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

Time frame: 12weeks

Changes in Interferon-gamma

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

Time frame: 12weeks

Changes in Interleukin-4

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

Time frame: 12weeks

Changes in Eosinophil

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

Data from ClinicalTrials.gov

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