The effectiveness of fermented turmeric powder in subjects with elevated alanine
transaminase levels: a randomised controlled study.
Author(s): Kim SW(1), Ha KC, Choi EK, Jung SY, Kim MG, Kwon DY, Yang HJ, Kim MJ, Kang HJ,
Back HI, Kim SY, Park SH, Baek HY, Kim YJ, Lee JY, Chae SW.
Affiliation(s): Author information:
(1)Clinical Trial Center for Functional Foods, Chonbuk National University Hospital,
Jeonju, Chonbuk 560-182, South Korea.
Publication date & source: 2013, BMC Complement Altern Med. , 13:58
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: NCT01634256
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