Open AccessEffect of Chongkukjang on histamine-induced skin wheal response: A randomized, double-blind, placebo-controlled trial
Author(s) -
Hyang-Im Baek,
Se Jin Jung,
Ki-Chan Ha,
HyeMi Kim,
EunKyung Choi,
SuJin Jung,
Eun-Ock Park,
SangWook Shin,
MinGul Kim,
Seok-Kweon Yun,
Dae-Young Kwon,
HyeJeong Yang,
Minjeong Kim,
Hee-Joo Kang,
Jinhee Kim,
Do-Youn Jeong,
Seung-Wha Jo,
Back-Hwan Cho,
SooWan Chae
Publication year - 2015
Publication title -
journal of ethnic foods
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.405
H-Index - 18
eISSN - 2352-619X
pISSN - 2352-6181
DOI - 10.1016/j.jef.2015.04.003
Subject(s) - medicine , placebo , histamine , immunoglobulin e , eosinophil cationic protein , randomized controlled trial , eosinophil , gastroenterology , allergy , adverse effect , immunology , food allergy , erythema , atopic dermatitis , anesthesia , asthma , antibody , pathology , alternative medicine
Background: Studies in animals have demonstrated the antiallergenic properties of Chongkukjang (CKJ), a traditional Korean food made by fermentation of soybean with Bacillus subtilis. CKJ might therefore be used as an ingredient in a functional food designed to suppress allergies. The purpose of this study was to investigate the effect of CKJ on histamine-induced skin wheal response in healthy participants.Methods: A randomized, double-blind, placebo-controlled trial was conducted. Sixty participants (48 women and 12 men) were randomly assigned to one of two groups: One group received 35 g CKJ daily for 12 weeks, and the other received a placebo at the same dosing frequency. A skin prick test with histamine (10 mg/mL) was conducted on the ventral forearm 10 cm from the elbow, and assessed 15 minutes later. Outcomes included measurement of efficacy [skin wheal response, immunoglobulin E (IgE), histamine, interferon-gamma, interleukin-4, eosinophil, and eosinophil cationic protein (ECP)], and safety (adverse events, laboratory test results, electrocardiogram, anthropometric values, and vital signs).Results: Fifty-five participants (28 in the CKJ group and 27 in the placebo group) completed the study. After 12 weeks of supplementation, participants in the CKJ group showed a significant reduction in histamine-induced skin wheal areas compared with placebo group (p < 0.05). At 12 weeks, the CKJ group showed a significant improvement in percentage change from baseline in histamine-induced wheal area, compared with the placebo group (p < 0.05). CKJ did not influence blood levels of IgE, histamine, interferon-gamma, interleukin-4, eosinophil, or ECP.Conclusion: Oral administration of CKJ for 12 weeks resulted in a reduction of the skin wheal response to histamine, with no apparent adverse effects. Trial registration: ClinicalTrials.gov: NCT01402141