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Open Access Highly Accessed Research article

The effectiveness of fermented turmeric powder in subjects with elevated alanine transaminase levels: a randomised controlled study

Sang-Wook Kim12, Ki-Chan Ha34, Eun-Kyung Choi1, Su-Young Jung1, Min-Gul Kim1, Dae-Young Kwon5, Hye-Jung Yang5, Min-Jung Kim5, Hee-Joo Kang5, Hyang-Im Back34, Sun-Young Kim13, Soo-Hyun Park1, Hum-Young Baek6, Yong-Jae Kim6, Joon-Yeol Lee6 and Soo-Wan Chae13*

Author Affiliations

1 Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, 560-182, Jeonju, Chonbuk, South Korea

2 Department of Internal Medicine and Research Institute of Clinical Medicine, Chonbuk National University Hospital, Jeonju, Republic of Korea

3 Department of Medical Nutrition Therapy, Chonbuk National University, Jeonju, Republic of Korea

4 Healthcare Claims & Management Incorporation, Jeonju, Republic of Korea

5 Korea Food Research Institute, Baekhyeon-dong, Bundang-gu, Seongnam-City, Gyeonggi-do, Republic of Korea

6 Korea INS Pharmaceutical Company, Daepo-ri, Dong-myeon, Hwasoon-gun, Jeollanam-do, Republic of Korea

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BMC Complementary and Alternative Medicine 2013, 13:58  doi:10.1186/1472-6882-13-58

Published: 8 March 2013

Abstract

Background

Previous animal studies have shown that Curcuma longa (turmeric) improves liver function. Turmeric may thus be a promising ingredient in functional foods aimed at improving liver function. The purpose of the study is to investigate the hepatoprotective effect of fermented turmeric powder (FTP) on liver function in subjects with elevated alanine transaminase (ALT) levels.

Methods

A randomised, double-blind, placebo-controlled trial was conducted between November 2010 and April 2012 at the clinical trial center for functional foods of the Chonbuk National University Hospital. The trial included 60 subjects, 20 years old and above, who were diagnosed mild to moderate elevated ALT levels between 40 IU/L and 200 IU/L. Sixty subjects were randomised to receive FTP 3.0 g per day or placebo 3.0 g per day for 12 weeks. The treatment group received two capsules of FTP three times a day after meals, for 12 weeks. The primary efficacy endpoint was change in the ALT levels in the two groups. The secondary efficacy endpoints included its effect on aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), total bilirubin (TB), and lipid profiles. Safety was assessed throughout the study using ongoing laboratory tests. Adverse events (AEs) were also recorded.

Results

Sixty subjects were randomised in the study (30 into the FTP group, 30 into the placebo group), and among them, twelve subjects were excluded from the analysis for protocol violation, adverse events or consent withdrawal. The two groups did not differ in baseline characteristics. After 12 weeks of treatment, 48 subjects were evaluated. Of the 48 subjects, 26 randomly received FTP capsules and 22 received placebo. The FTP group showed a significant reduction in ALT levels after 12 weeks of treatment compared with the placebo group (p = 0.019). There was also observed that the serum AST levels were significantly reduce in the FTP group than placebo group (p = 0.02). The GGT levels showed a tendency to decrease, while the serum alkaline phosphatase (ALP), TB, and lipids levels were not modified. There were no reported severe AEs during this study, or abnormalities observed on blood glucose, total protein, albumin, blood urea nitrogen (BUN), and creatinine levels.

Conclusion

The data of this trial indicate that FTP is effective and safe, generally well-tolerated without severe AEs, in the treatment of subjects with elevated ALT levels over a 12 weeks period.

Trial registration

ClinicalTrials.gov: http://NCT01634256 webcite