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

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://NCT0163425

Effect of Chongkukjang on histamine-induced skin wheal response: A randomized, double-blind, placebo-controlled trial

AbstractBackgroundStudies 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.MethodsA 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).ResultsFifty-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.ConclusionOral 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

A placebo-controlled trial of Korean red ginseng extract for preventing Influenza-like illness in healthy adults

<p>Abstracts</p> <p>Background</p> <p>Standardized Korean red ginseng extract has become the best-selling influenza-like illness (ILI) remedy in Korea, yet much controversy regarding the efficacy of the Korean red ginseng (KRG) in reducing ILI incidence remains. The aim of the study is to assess the efficacy of the KRG extract on the ILI incidence in healthy adults.</p> <p>Methods/Design</p> <p>We will conduct a randomized, double-blind, placebo-controlled study at the onset of the influenza seasons. A total of 100 subjects 30-70 years of age will be recruited from the general populations. The subjects will be instructed to take 9 capsules per day of either the KRG extract or a placebo for a period of 3 months. The primary outcome measure is to assess the frequency of ILI onset in participated subjects. Secondary variable measures will be included severity and duration of ILI symptoms. The ILI symptoms will be scored by subjects using a 4-point scale.</p> <p>Discussion</p> <p>This study is a randomized placebo controlled trial to evaluate the efficacy of the KRG extract compared to placebo and will be provided valuable new information about the clinical and physiological effects of the KRG extract on reduction of ILI incidence including flu and upper respiratory tract infections. The study has been pragmatically designed to ensure that the study findings can be implemented into clinical practice if KRG extract can be shown to be an effective reduction strategy in ILI incidence.</p> <p>Trial Registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT01478009">NCT01478009</a>.</p