title: The effectiveness of fermented turmeric powder in subjects with elevated alanine transaminase levels: a randomised controlled study.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01634256
authors.affiliation: Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Chonbuk 560-182, South Korea.
authors.forename: Sang-Wook
authors.initials: SW
authors.lastname: Kim
authors.forename: Ki-Chan
authors.initials: KC
authors.lastname: Ha
authors.forename: Eun-Kyung
authors.initials: EK
authors.lastname: Choi
authors.forename: Su-Young
authors.initials: SY
authors.lastname: Jung
authors.forename: Min-Gul
authors.initials: MG
authors.lastname: Kim
authors.forename: Dae-Young
authors.initials: DY
authors.lastname: Kwon
authors.forename: Hye-Jung
authors.initials: HJ
authors.lastname: Yang
authors.forename: Min-Jung
authors.initials: MJ
authors.lastname: Kim
authors.forename: Hee-Joo
authors.initials: HJ
authors.lastname: Kang
authors.forename: Hyang-Im
authors.initials: HI
authors.lastname: Back
authors.forename: Sun-Young
authors.initials: SY
authors.lastname: Kim
authors.forename: Soo-Hyun
authors.initials: SH
authors.lastname: Park
authors.forename: Hum-Young
authors.initials: HY
authors.lastname: Baek
authors.forename: Yong-Jae
authors.initials: YJ
authors.lastname: Kim
authors.forename: Joon-Yeol
authors.initials: JY
authors.lastname: Lee
authors.forename: Soo-Wan
authors.initials: SW
authors.lastname: Chae
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood*; D001219:Aspartate Aminotransferases / Q000097:blood; D001663:Bilirubin / Q000097:blood; D030024:Curcuma; D004311:Double-Blind Method; D005260:Female; D005285:Fermentation; D006801:Humans; D008099:Liver / Q000187:drug effects* / Q000201:enzymology; D008107:Liver Diseases / Q000097:blood / Q000188:drug therapy* / Q000201:enzymology; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D028321:Plant Preparations / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D005723:gamma-Glutamyltransferase / Q000097:blood
chemical_list: D028321:Plant Preparations; D005723:gamma-Glutamyltransferase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D001663:Bilirubin