Journal of Food Hygiene and Safety (한국식품위생안전성학회지)

The Korean Society of Food Hygiene and Safety (한국식품위생안전성학회)
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The Effects of Ecklonia stolonifera Extracts on Improvement of Hepatic Function: a Double-Blind, Randomized, Placebo-Controlled Clinical Study

곰피추출물의 간기능 개선 효과 평가를 위한 12주, 무작위배정, 이중맹검, 위약-대조 인체적용시험

  • Kim, Junghee (R&D Center, Naturalway Co. Ltd.) ;
  • Kim, Eun Jin (R&D Center, Naturalway Co. Ltd.) ;
  • Kang, Dahye (R&D Center, Naturalway Co. Ltd.) ;
  • Kim, Hyung-Bin (R&D Center, Naturalway Co. Ltd.) ;
  • Jang, Jae Young (Department of Internal Medicine, Institute for Digestive Research, Digestive Disease Center, Soonchunhyang University College of Medicine) ;
  • Om, Ae-Son (Department of Food and Nutrition, College of Human Ecology, Hanyang University) ;
  • Kim, Jongwook (R&D Center, Naturalway Co. Ltd.)
  • 김정희 ((주)네추럴웨이 R&D센터) ;
  • 김은진 ((주)네추럴웨이 R&D센터) ;
  • 강다혜 ((주)네추럴웨이 R&D센터) ;
  • 김형빈 ((주)네추럴웨이 R&D센터) ;
  • 장재영 (순천향대학교 서울병원 소화기내과) ;
  • 엄애선 (한양대학교 생활과학대학 식품영양학과) ;
  • 김종욱 ((주)네추럴웨이 R&D센터)
  • Received : 2022.04.29
  • Accepted : 2022.06.13
  • Published : 2022.06.30
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Abstract

Hepatic diseases are divided into two types: alcoholic and non-alcoholic. Non-alcoholic liver injury finally induces fatty liver and damages liver function. Many studies have demonstrated that Ecklonia stolonifera has antioxidative, anti-inflammatory, and hepatoprotective activities. We conducted a 12-week double-blind, placebo-controlled, randomized trial to examine the efficacy of E. stolonifera extracts (ESE) on biochemical markers of hepatic function. Sixty-five subjects with mild or moderate liver injuries were randomly allocated to receive either 420 mg/d of ESE or a placebo for 12 weeks. Fifty-five participants completed the trial. No significant adverse events were observed among the subjects during the study. The primary end points were changes in plasma levels of aspartate transaminase (AST), alanine transaminase (ALT), and γ-glutamyltransferase (γ-GT). The secondary end points were changes in lipid profile levels, including total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL). Compared with the baseline, AST and ALT levels decreased significantly in the ESE group compared to those in the placebo group (P<0.001). In addition, γ-GT levels in the ESE group were significantly lower than those in the placebo group (P=0.016). There were no differences in the TC, TG, HDL, and LDL levels between groups. In conclusion, ESE consumption for 12 weeks improved liver parameters in subjects with liver injury. Regular consumption of ESE could maintain liver health in individuals at risk of hepatic damage.

본 연구에서는 경증 또는 중등도 간기능 이상 소견자를 대상으로 ESE의 간기능 개선 효과를 평가하기 위해 시험식품군과 대조식품군으로 나누어 단일기관, 위약대조, 무작위배정, 이중눈가림 평행 인체적용시험으로 연구를 수행하였다. 12주간 ESE 420 mg(210 mg/포, 1일 2회)을 함유한 시험식품 또는 대조식품을 섭취하였을 때 ESE의 간 기능 개선 유효성과 안전성을 평가하였다. 유효성 평가 결과, 섭취 후 시험식품군은 대조식품군과 비교하여 ALT, AST, γ-GT 수준이 유의하게 감소하였다. 반면, 지질대사 지표는 두 군간의 의미 있는 차이를 보이지 않았다. 또한, 비알콜성 시험대상자군을 대상으로 분석하였을 때도 ALT 및 AST 수준이 유의하게 감소하였으며 γ-GT의 경우 감소하는 경향성을 보였다. 안전성 평가로서 혈액, 소변, 활력 징후를 검사한 결과 대부분 항목에서 시험식품군과 대조식품군 군간 차이가 없었으며 몇몇 유의성이 나타난 지표도 임상적 의미는 없었다. 따라서 ESE는 간기능 개선에 도움을 줄 수 있을 것으로 보이며 안전한 식품 소재로 판단된다.

Keywords

Acknowledgement

이 논문은 2015년도 농림축산식품부 기술사업화지원사업 및 2022년도 해양수산부 재원으로 해양수산과학기술진흥원의 지원을 받아 수행된 연구임(20200362, 해양바이오 전략소재 개발 및 제품 상용화 지원).

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