Efficacy of artichoke leaf extract in non‐alcoholic fatty liver disease: A pilot double‐blind randomized controlled trial

Non‐alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease worldwide and is potentially treatable, though there are few therapeutic agents available. Artichoke leaf extract (ALE) has shown potential as a hepatoprotective agent. This study sought to determine if ALE had therapeutic utility in patients with established NAFLD. In this randomized double‐blind placebo‐controlled parallel‐group trial, 100 subjects with ultrasound‐diagnosed NAFLD were randomized to either ALE 600 mg daily or placebo for a 2‐month period. NAFLD response was assessed by liver ultrasound and serological markers including the aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio and AST to platelet ratio index (APRI) score. Ninety patients completed the study (49 ALE and 41 placebo) with no side effects reported. ALE treatment compared with placebo: Doppler sonography showed increased hepatic vein flow (p < .001), reduced portal vein diameter (p < .001) and liver size (p < .001), reduction in serum ALT (p < .001) and AST (p < .001) levels, improvement in AST/ALT ratio and APRI scores (p < .01), and reduction in total bilirubin. ALE supplementation reduced total cholesterol, low‐density lipoprotein cholesterol, high‐density lipoprotein cholesterol, non‐high‐density lipoprotein cholesterol, and triglyceride concentrations (p = .01). This study has shown beneficial effects of ALE supplementation on both ultrasound liver parameters and liver serum parameters (ALT, AST, APRI ratio, and total bilirubin) in patients with NAFLD.     

Hesperidin improves hepatic steatosis,hepatic enzymes,and metabolic and inflammatory parameters in patients with nonalcoholic fatty liver disease: A randomized,placebo‐controlled,double‐blind clinical trial

This study aimed to evaluate the effects of hesperidin on nonalcoholic fatty liver disease (NAFLD) characteristics. In this randomized, double‐blind, controlled clinical trial, 50 NAFLD patients were supplemented with either 1‐g hesperidin capsule or identical placebo capsule for 12 weeks. During the intervention, both groups were advised to follow healthy lifestyle habits including dietary and physical activity recommendations. At the end of the study, hesperidin supplementation, compared with placebo, was associated with a significant reduction in alanine aminotransferase (p = .005), γ‐glutamyltransferase (p = .004), total cholesterol (p = .016), triglyceride (p = .049), hepatic steatosis (p = .041), high‐sensitivity C‐reactive protein (p = .029), tumor necrosis factor‐α, and nuclear factor‐κB (NF‐κB). In conclusion, our results indicate that hesperidin supplementation accompanied with lifestyle modification is superior to lifestyle modification alone in management of NAFLD at least partially through inhibiting NF‐κB activation and improving lipid profile. Further studies with higher dose of hesperidin are required to find the optimal dose.     

Effects of green tea or green tea catechin on liver enzymes in healthy individuals and people with nonalcoholic fatty liver disease: A systematic review and meta‐analysis of randomized clinical trials

The therapeutic potential of green tea as a rich source of antioxidants and anti‐inflammatory compounds has been investigated by several studies. The present study aimed to systematically review and analyze randomized clinical trials (RCTs) assessing the effects of green tea, catechin, and other forms of green tea supplementation on levels of liver enzymes. PubMed, SCOPUS, EMBASE, and Cochrane databases were searched until February 2019. All RCTs investigating the effect of green tea or its catechin on liver enzymes including alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and bilirubin were included. A total of 15 RCTs were included. The overall effect of green tea on liver enzymes was nonsignificant (ALT [Standardized mean difference (SMD)= ?0.17, CI ?0.42 to 0.08, p = .19], AST [SMD = ?0.07, CI ?0.43 to 0.29, p = .69], and ALP [SMD = ?0.17, CI ?0.45 to 0.1, p = .22]). However, subgroup analyses showed that green tea reduced the levels of liver enzymes in participants with nonalcoholic fatty liver disease (NAFLD) but in healthy subjects, a small significant increase in liver enzymes was observed. In conclusion, the results of this study suggest that the effect of green tea on liver enzymes is dependent on the health status of individuals. While a moderate reducing effect was observed in patients with NAFLD, in healthy subjects, a small increasing effect was found.     

The effects of black seed supplementation on cardiovascular risk factors in patients with nonalcoholic fatty liver disease: A randomized,double‐blind,placebo‐controlled clinical trial

Nonalcoholic fatty liver disease (NAFLD) is highly related to cardiovascular disorders risk factors. This study aimed to evaluate the effects of black seed (Nigella sativa) supplementation on cardiovascular disorders risk factors in patients with NAFLD. This randomized, double‐blind, placebo‐controlled clinical trial was conducted on 50 patients with NAFLD. Participants were assigned to receive a lifestyle modification plus 2 g/day of either N. sativa or placebo for 12 weeks. Compared with the placebo, N. sativa supplementation led to significant reductions in serum glucose (?7.95 vs. ?1.22; p = .041), serum insulin (?3.87 vs. ?1.07; p = .027), homeostatic model of assessment for insulin resistance (?1.02 vs. ?0.28; p = .021), and a significant increase in quantitative insulin sensitivity check index (0.03 vs. 0.006; p = .002). All of these changes were remained significant after adjusting for known confounding variables; however, there was no significant difference in lipid profile changes between the two groups (p = .05). N. sativa supplementation significantly decreased hepatic steatosis percentage compared with the placebo after adjustment for confounding variables (p = .005). In conclusion, our results indicate that daily intake of 2‐g N. sativa plus lifestyle modification is superior to lifestyle modification alone in amelioration of insulin resistance and hepatic steatosis in patients with NAFLD.     

The efficacy of sour tea (Hibiscus sabdariffa L.) on selected cardiovascular disease risk factors: A systematic review and meta‐analysis of randomized clinical trials

This study sought to summarize clinical evidence of sour tea (Hibiscus sabdariffa L.) administration on cardiovascular disease risk factors. PubMed, Scopus, Institute for Scientific Information Web of Science, and Google Scholar were systematically searched from inception to June 2019 to identify randomized clinical trials, which assessed the effect of sour tea consumption on lipid profiles, fasting plasma glucose, and blood pressure in adult populations. Mean and standard deviation for each parameter were extracted to calculate effect size. Cochrane Collaboration tools were used to evaluate risk of bias assessment. A total of seven randomized clinical trials consisting 362 participants were included in the meta‐analysis. Pooled effect size demonstrated that sour tea consumption significantly reduces fasting plasma glucose (?3.67 mg/dl, 95% confidence interval, CI [?7.07, ?0.27]; I² = 37%), systolic blood pressure (?4.71 mmHg, 95% CI [?7.87, ?1.55]; I² = 53%), and diastolic blood pressure (?4.08 mmHg, 95% CI [?6.48, ?1.67]; I² = 14%). Although no significant effect was observed on triacylglycerol, total cholesterol, and high‐density lipoprotein cholesterol following sour tea consumption, a trend toward a significant reduction was found in low‐density lipoprotein cholesterol serum concentrations (p = 0.08). This systematic review and meta‐analysis suggests that sour tea consumption could have beneficial effect in controlling glycemic status and blood pressure among adult population.     

The effects of curcumin supplementation on body mass index,body weight,and waist circumference in patients with nonalcoholic fatty liver disease: A systematic review and dose–response meta‐analysis of randomized controlled trials

Nonalcoholic fatty liver disease (NAFLD) is a major cause of liver‐related morbidity; its prevalence is elevating due to the rising epidemic of obesity. Several clinical trials have examined the effects of curcumin supplementation on anthropometric variables in NAFLD patients with inconclusive results. This dose–response meta‐analysis aimed to evaluate the impact of curcumin supplementation on body mass index (BMI), body weight, and waist circumference (WC) in patients with NAFLD. A systematic review of the literature was conducted using PubMed/Medline, ISI Web of Science, Scopus, Cochrane Library, EMBASE, Google Scholar, Sid.ir, and Magiran.com to identify eligible studies up to March 2019. A meta‐analysis of eligible studies was performed using the random‐effects model to estimate the pooled effect size. Eight randomized controlled trials with 520 participants (curcumin group = 265 and placebo group = 255) were included. Supplementation dose and duration ranged from 70 to 3,000 mg/day and 8 to 12 weeks, respectively. Curcumin supplementation significantly reduced BMI (weighted mean difference [WMD] = ?0.34 kg/m², 95% CI [?0.64, ?0.04], p < .05) and WC (WMD = ?2.12 cm, 95% CI [?3.26, ?0.98], p < .001). However, no significant effects of curcumin supplementation on body weight were found. These results suggest that curcumin supplementation might have a positive effect on visceral fat and abdominal obesity that have been associated with NAFLD.     

Treatment of Non‐alcoholic Fatty Liver Disease with Curcumin: A Randomized Placebo‐controlled Trial

Non‐alcoholic fatty liver disease (NAFLD) is a global health problem. Although many aspects of NAFLD pathogenesis have been understood, there is a paucity of effective treatments to be used as the second line when lifestyle modification is insufficient. Curcumin, a natural polyphenol from turmeric, has been shown to be effective against development of hepatic steatosis and its progression to steatohepatitis, yet these beneficial effects have not been explored in clinical practice. The aim of this study is to investigate the effects of curcumin on hepatic fat content as well as biochemical and anthropometric features of patients with NAFLD. In this randomized double‐blind placebo‐controlled trial, patients with ultrasonographic evidence of NAFLD were randomly assigned to receive an amorphous dispersion curcumin formulation (500 mg/day equivalent to 70‐mg curcumin) or matched placebo for a period of 8 weeks. Liver fat content (assessed through ultrasonography), glycemic and lipid profile, transaminase levels, and anthropometric indices were evaluated at baseline and at the end of follow‐up period. The clinical trial protocol was registered under the Iranian Registry of Clinical Trials ID: IRCT2014110511763N18. Compared with placebo, curcumin was associated with a significant reduction in liver fat content (78.9% improvement in the curcumin vs 27.5% improvement in the placebo group). There were also significant reductions in body mass index and serum levels of total cholesterol, low‐density lipoprotein cholesterol, triglycerides, aspartate aminotransferase, alanine aminotransferase, glucose, and glycated hemoglobin compared with the placebo group. Curcumin was safe and well tolerated during the course of trial. Findings of the present proof‐of‐concept trial suggested improvement of different features of NAFLD after a short‐term supplementation with curcumin. Copyright © 2016 John Wiley & Sons, Ltd.     

The effect of l‐carnitine supplementation on serum levels of omentin‐1, visfatin and SFRP5 and glycemic indices in patients with pemphigus vulgaris: A randomized,double‐blind,placebo‐controlled clinical trial

Pemphigus vulgaris (PV) is a chronic autoimmune disorder with potentially fatal outcomes. The aim of this study was to investigate the effect of l ‐carnitine (LC) on secreted frizzled‐related protein‐5 (SFRP5), omentin, visfatin, and glycemic indices in PV patients under corticosteroid treatment. In this randomized, double‐blind, placebo‐controlled clinical trial, 52 patients with PV were divided randomly into two groups to receive 2 g of LC or a placebo for 8 weeks. Serum levels of SFRP5, omentin, visfatin, and also glycemic indices were evaluated at the baseline and end of the study. LC supplementation significantly decreased the serum level of visfatin (95% CI [?14.718, ?0.877], p = .05) and increased the serum levels of SFRP5 (95%CI [1.637, 11.380], p < .006) and omentin (95% CI [9.014, 65.286], p < .01). However, LC supplementation had no significant effects on the serum levels of glycemic factors such as insulin (95% CI [?1.125, 3.056], p = .426), fasting blood sugar (95% CI [?4.743, 3.642], p = .894), homeostatic model assessment of insulin resistance (95% CI [?0.305, 0.528], p = .729), and quantitative insulin‐sensitivity check index (95% CI [?0.016, ?0.010], p = .81). LC supplementation decreased visfatin serum level and increased omentin‐1 and SFRP5 serum levels in patients with PV. However, it has no significant effect on the serum levels of insulin and glycemic indices.     

Quercetin improves nonalcoholic fatty liver by ameliorating inflammation,oxidative stress,and lipid metabolism in db/db mice

Multiphase pathological processes involve in Type 2 diabetes (T2DM)‐induced nonalcoholic fatty liver disease (NAFLD). However, the therapies are quite limited. In the present study, the hepatoprotective effects and underlying mechanisms of quercetin in T2DM‐induced NAFLD were investigated. T2DM‐induced NAFLD and quercetin treatment models were established in vivo and in vitro. The results revealed that quercetin alleviated serum transaminase levels and markedly reduced T2DM‐induced histological alterations of livers. Additionally, quercetin restored superoxide dismutase, catalase, and glutathione content in livers. Not only that, quercetin markedly attenuated T2DM‐induced production of interleukin 1 beta, interleukin 6, and TNF‐α. Accompanied by the restoration of the increased serum total bile acid (p = .0001) and the decreased liver total bile acid (p = .0005), quercetin could reduce lipid accumulation in the liver of db/db mice. Further mechanism studies showed that farnesoid X receptor 1/Takeda G‐protein‐coupled receptor 5 signaling pathways was involved in quercetin regulation of lipid metabolism in T2DM‐induced NAFLD. In high D‐glucose and free fatty acid cocultured HepG2 cells model, quercetin eliminated lipid droplets and restored the upregulated total cholesterol and triglyceride levels. Similar to the findings in mice, quercetin could also activate farnesoid X receptor 1/Takeda G‐protein‐coupled receptor 5 signaling pathway. These findings suggested that quercetin might be a potentially effective drug for the treatment of T2DM‐induced NAFLD.     

Effect of curcumin supplementation on disease severity in patients with liver cirrhosis: A randomized controlled trial

Recent reports indicated that curcumin had beneficial effects in animal models of liver injury and cirrhosis. Current study aimed to investigate the effects of curcumin supplementation in patients with liver cirrhosis. In this randomized double‐blind placebo‐controlled trial, 70 patients with liver cirrhosis aged 20–70 years were randomly divided into two groups to receive 1,000 mg/day curcumin (n = 35) or placebo (n = 35) for 3 months. Model for end‐stage liver disease (MELD) (i), MELD, MELD‐Na, and Child–Pugh scores were used to assess the severity of cirrhosis. Sixty patients (29 in the curcumin group and 31 in the placebo group) completed the study. MELD(i) (15.55 ± 3.78 to 12.41 ± 3.07), MELD (15.31 ± 3.07 to 12.03 ± 2.79), MELD‐Na (15.97 ± 4.02 to 13.55 ± 3.51), and Child–Pugh (7.17 ± 1.54 to 6.72 ± 1.31) scores decreased significantly in the curcumin group after 3‐month intervention (p < .001, p < .001, p = .001, and p = .051, respectively), whereas they increased significantly in the placebo group (p < .001, p < .001, p < .001, p = .001, respectively). Significant differences were only observed between the two groups in MELD(i), MELD, MELD‐Na, and Child–Pugh scores after 3‐month intervention (p < .001 for all of them). In this pilot study, beneficial effects of curcumin supplementation were observed in decreasing disease activity scores and severity of cirrhosis in patients with cirrhosis.     

Does turmeric/curcumin supplementation improve serum alanine aminotransferase and aspartate aminotransferase levels in patients with nonalcoholic fatty liver disease? A systematic review and meta‐analysis of randomized controlled trials

We performed a meta‐analysis to evaluate the efficacy of turmeric/curcumin supplementation on serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in patients with nonalcoholic fatty liver disease (NAFLD). We searched PubMed, Scopus, Cochrane Library, ISI Web of Science, and Google Scholar up to November 20, 2018. Studies that examined the effect of turmeric/curcumin on serum concentrations of ALT and AST among patients with NAFLD were included. The mean difference and standard deviation (SD) of changes in ALT and AST between intervention and control groups were used as effect size for the meta‐analysis. A total of six randomized controlled trials (RCTs) were eligible for meta‐analysis. Results from pooled analysis revealed that turmeric/curcumin supplementation reduced ALT (MD: ?7.31 UL/L, 95% CI [?13.16, ?1.47], p = 0.014) and AST (MD: ?4.68 UL/L, 95% CI [?8.75 ?0.60], p = 0.026). When RCTs stratified on the basis of their treatment duration, the significant reduction in serum concentrations of ALT and AST was observed only in studies lasting less than 12 weeks. This review suggests that turmeric/curcumin might have a favorable effect on serum concentrations of ALT and AST in patients with NAFLD. However, further clinical trials are needed to confirm these findings.     

An investigation of the effects of curcumin on iron overload,hepcidin level,and liver function in β‐thalassemia major patients: A double‐blind randomized controlled clinical trial

This study investigated the effects of curcumin, the active polyphenol in turmeric, on iron overload, hepcidin level, and liver function in β‐thalassemia major patients. This double‐blind randomized controlled clinical trial was conducted on 68 β‐thalassemia major patients. The subjects were randomly divided into 2 groups to receive either 500 mg curcumin capsules (total: 1,000 mg) twice daily or placebo for 12 weeks. Dietary intakes and biochemical variables including hemoglobin, transferrin saturation, total iron binding capacity, nontransferrin bound iron (NTBI), ferritin, hepcidin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were assessed at the beginning and end of the trial. Curcumin significantly reduced serum levels of NTBI (2.83 ± 1.08 compared with 2.22 ± 0.97 μmol/L, p = .001), ALT (42.86 ± 11.15 compared with 40.60 ± 9.89 U/L, p = .018), and AST (49.45 ± 12.39 compared with 46.30 ± 10.85 U/L, p = .002) at the end of the study. Based on analysis of covariance, a significant decrease was also observed in levels of NTBI (2.22 ± 0.97 vs. 2.55 ± 0.94 μmol/L, p = .026), ALT (40.60 ± 9.89 vs. 45.01 ± 10.42 U/L, p = .004), and AST (46.30 ± 10.85 vs. 50.99 ± 9.36 U/L, p = .009) in curcumin group in comparison with placebo group. There were no significant changes in hepcidin and other variables in any of the 2 groups. Curcumin administration alleviated iron burden and liver dysfunction by reducing NTBI, ALT, and AST levels in patients with β‐thalassemia major.

     

Efficacy of a Standardized Extract of Prunus mume in Liver Protection and Redox Homeostasis: A Randomized,Double‐Blind,Placebo‐Controlled Study

The antioxidant, anti‐inflammatory and hepatoprotective effects of Prunus mume (PM) have previously been demonstrated. This double‐blind, placebo‐controlled study was designed to evaluate the influence of two doses of a food supplement, made of 150 mg of a standardized PM extract on liver transaminases, lipid profile, glycemia, neopterin and reduced and oxidized thiols in plasma and erythrocytes, during a 3‐month treatment period, in healthy subjects with transaminases levels between 20 and 40 UI/L. Forty‐five subjects (56.0 ± 11.6 years) were enrolled. The results showed a beneficial and statistically significant effect versus placebo of PM extract on liver function, with a decrease versus baseline in alanine aminotransferase (47%), aspartate aminotransferase (7%), gamma‐glutamyl transpeptidase (15%) and glycemia (11%). The lipid profile modification was also positive with an increase versus baseline in HDL cholesterol (13%), and a decrease in LDL/HDL ratio (12%) and triglycerides (8%). The antioxidant action of PM translated into a decrease in oxidized glutathione, reduced/oxidized cysteine‐glycine, oxidized cysteine (intracellular pro‐oxidant) and neopterin (inflammation biomarker), was associated with an increase in reduced glutathione. These results are in favor of the use of a standardized extract of P. mume for the support of liver health and prevention of common metabolic and inflammation‐based diseases. Copyright © 2016 John Wiley & Sons, Ltd.     

茵陈蒿汤合四逆散治疗非酒精性脂肪肝伴高同型半胱氨酸血症临床观察

目的:探讨茵陈蒿汤合四逆散对非酒精性脂肪肝(NAFLD)伴高同型半胱氨酸血症(HHcy)患者的临床疗效。方法:病例来源于北京市西城区什刹海社区卫生服务中心门诊共126例NAFLD伴HHcy患者,随机数字表法分为脂肪肝对照组(安慰剂)、西药组(多烯磷脂酰胆碱胶囊和叶酸片)、中药组(茵陈蒿汤合四逆散方),42例/组,治疗期间无脱落;连续治疗3个月。观察治疗前后临床有效率,观察肝功能[丙氨酸氨基转移酶(ALT),天门冬氨酸氨基转移酶(AST)],同型半胱氨酸(Hcy),血脂[总胆固醇(TC),总甘油三酯(TG),低密度脂蛋白(LDL),高密度脂蛋白(HDL)],氧化炎症指标[丙二醛(MDA),超氧化物酶歧化酶(SOD),超敏C反应蛋白(hs-CRP)],安全性评价指标肾功能(血肌酐(SCr),血尿素氮(BUN)]以及症状评分。结果:中药组总有效率92. 86%;西药组总有效率88. 10%;两组总有效率比较无统计学差异。各组患者治疗前各指标无差异。治疗后中药组、西药组ALT,AST,Hcy,TC,TG,MDA,hs-CRP,症状积分较本组治疗前明显降低(P 0. 05),且低于脂肪肝对照组(P 0. 05); HDL,SOD明显升高(P 0. 05),且高于脂肪肝对照组(P 0. 05);与西药组比较,中药组ALT,Hcy,TC,TG,MDA,hs-CRP,症状积分明显降低(P 0. 05),SOD明显升高(P 0. 05)。结论:茵陈蒿汤合四逆散改善NAFLD伴Hcy患者的高同型半胱氨酸血症、肝功能、血脂以及氧化、炎症状态。     

Adjuvant Therapy with Bioavailability‐Boosted Curcuminoids Suppresses Systemic Inflammation and Improves Quality of Life in Patients with Solid Tumors: A Randomized Double‐Blind Placebo‐Controlled Trial

Curcuminoids are bioactive polyphenolics with potent antiinflammatory properties. Although several lines of in vitro and preclinical evidence suggest potent anticancer effects of curcuminoids, clinical findings have not been conclusive. The present randomized double‐blind placebo‐controlled trial aimed to evaluate the efficacy of curcuminoids as adjuvant therapy in cancer patients. Eighty subjects with solid tumors who were under standard chemotherapy regimens were randomly assigned to a bioavailability‐boosted curcuminoids preparation (180 mg/day; n = 40) or matched placebo (n = 40) for a period of 8 weeks. Efficacy measures were changes in the health‐related quality of life (QoL) score (evaluated using the University of Washington index) and serum levels of a panel of mediators implicated in systemic inflammation including interleukins 6 (IL‐6) and 8 (IL‐8), TNF‐α, transforming growth factor‐β (TGFβ), high‐sensitivity C‐reactive protein (hs‐CRP), calcitonin gene‐related peptide (CGRP), substance P and monocyte chemotactic protein‐1 (MCP‐1). Curcuminoid supplementation was associated with a significantly greater improvement in QoL compared with placebo (p < 0.001). Consistently, the magnitude of reductions in TNF‐α (p < 0.001), TGFβ (p < 0.001), IL‐6 (p = 0.061), substance P (p = 0.005), hs‐CRP (p < 0.001), CGRP (p < 0.001) and MCP‐1 (p < 0.001) were all significantly greater in the curcuminoids versus placebo group. In contrast, the extent of reduction in serum IL‐8 was significantly greater with placebo versus curcuminoids (p = 0.012). Quality of life variations were associated with changes in serum TGFβ levels in both correlation and regression analyses. Adjuvant therapy with a bioavailable curcuminoid preparation can significantly improve QoL and suppress systemic inflammation in patients with solid tumors who are under treatment with standard chemotherapy protocols. Copyright © 2014 John Wiley & Sons, Ltd.     

Supplementation with Cynanchum wilfordii radix extract for 8 weeks lowers serum total cholesterol: A controlled,randomized, double‐blind clinical trial

This trial aimed to determine the effect of a standardized Cynanchum wilfordii Radix extract (CWE) on the lipid profiles of individuals with elevated total cholesterol (T‐Chol) using a double‐blind randomized placebo‐controlled design. Ninety‐six Korean individuals with elevated T‐Chol level (200–240 mg/dL) were recruited and randomly allocated to groups that received VasH300 (300 mg CWE/day, n = 32), VasH600 (600 mg CWE/day, n = 32), or a placebo (n = 32) groups. Primary outcomes included T‐Chol, low‐density lipoprotein (LDL)‐cholesterol, high‐density lipoprotein (HDL)‐cholesterol, triglyceride, and safety (adverse events, biochemical parameters, and hematological parameters). Data were compared using a one‐way analysis of variance followed by Duncan's post‐hoc tests (among groups) and paired t tests (within groups). Values for T‐Chol and LDL‐cholesterol were significantly reduced in the VasH300 and groups (VasH300: 4.0 and 6.4%, respectively; VasH600; 3.8 and 5.8% respectively; both p < .05) compared with the placebo group and were not dose‐dependent. VasH300 significantly improved the lipid profiles of individuals with elevated T‐Chol without any serious side effects. Daily supplementation with VasH might be an alternative strategy with which to modify cholesterol‐related parameters, especially in individuals with elevated T‐Chol levels.     

Effects of crocin and saffron aqueous extract on gene expression of SIRT1, AMPK,LOX1, NF‐κB,and MCP‐1 in patients with coronary artery disease: A randomized placebo‐controlled clinical trial

This trial evaluated the potential impacts of saffron aqueous extract (SAE) and its main carotenoid on some of the atherosclerosis‐related gene expression and serum levels of oxidized low‐density cholesterol (ox‐LDL) and Monocyte chemoattractant protein 1 (MCP‐1) in patients with coronary artery disease (CAD). Participants of this randomized controlled trial included 84 CAD patients who categorized into three groups: Group 1 received crocin (30 mg/day), Group 2 SAE (30 mg/day), and Group 3 placebo for 8 weeks. Gene expression of Sirtuin 1 (SIRT1), 5'‐adenosine monophosphate‐activated protein kinase (AMPK), Lectin‐like oxidized LDL receptor 1 (LOX1), nuclear factor kappa‐light‐chain‐enhancer of activated B cells (NF‐κB), and MCP‐1 in peripheral blood mononuclear cells assessed by real‐time PCR. Furthermore, serum ox‐LDL and MCP‐1 levels measured at the beginning and end of the intervention. Compared with the placebo group, gene expression of SIRT1 and AMPK increased significantly in the crocin group (p = .001), and the expression of LOX1 and NF‐κB decreased significantly (p = .016 and .004, respectively). Serum ox‐LDL levels decreased significantly in the crocin group after the intervention (p = .002) while MCP‐1 levels decreased both in crocin and SAE groups (p = .001). Crocin may have beneficial effects on CAD patients by increasing the gene expression of SIRT1 and AMPK and decreasing the expression of LOX1 and NF‐κB.     

Barberry Treatment Reduces Serum Anti‐Heat Shock Protein 27 and 60 Antibody Titres and High‐sensitivity C‐reactive Protein in Patients with Metabolic Syndrome: A Double‐blind,Randomized Placebo‐controlled Trial

Metabolic syndrome is an important risk factor for cardiovascular disease (CVD). The heat shock proteins (HSPs) are associated with risk factors for CVD. The aim of the present study was to survey the effect of barberry on antibody titres to HSPs and high‐sensitivity C‐reactive protein (hs‐CRP) in patients with metabolic syndrome. In our study, subjects (N = 106, 79 women and 27 men, 18–65 years old) with metabolic syndrome were randomized into two groups: a group of patients who received three capsules of barberry and a control group who received three capsules of placebo for 6 weeks. Antibodies against HSPs 27, 60/65 and 70, hs‐CRP and lipid profile were determined in patients before (week 0) and after (week 6) intervention. spss software (version 16.0; Inc, Chicago, IL) was used for data analysis. Results showed that barberry had no significant effect on serum level of anti‐HSPs 65 and 70. But there was a significant decrease in anti‐HSP 27 in both case and control groups (p = 0.001 and p < 0.001, respectively, in the case and control groups). Barberry decreased significantly anti‐HSP 60 in the case group (p = 0.03). High‐sensitivity CRP was decreased non‐significantly (p = 0.17) in the case group and increased significantly (p = 0.04) in the control group. Barberry decreased significantly low‐density lipoprotein and total cholesterol and increased significantly high‐density cholesterol (p < 0.05). Results of the present study suggested that barberry supplementation in patients with metabolic syndrome decreased significantly anti‐HSPs 27 and 60 and hs‐CRP levels and improved lipid profile. Copyright © 2014 John Wiley & Sons, Ltd.     

Acute cardiovascular effects of bitter orange extract (p‐synephrine) consumed alone and in combination with caffeine in human subjects: A placebo‐controlled,double‐blind study

The purpose was to examine cardiovascular responses to supplementation with p‐synephrine alone and in combination with caffeine during quiet sitting. Sixteen subjects were given (in double‐blind manner) either 103 mg of p‐synephrine (S), 233 mg of caffeine +104 mg of p‐synephrine (LC + S), 240 mg of caffeine (LC), 337 mg of caffeine +46 mg of p‐synephrine (HC + S), 325 mg of caffeine (HC), or a placebo. The subjects sat quietly for 3 hr while heart rate (HR) and blood pressure were measured. Only HC + S and HC significantly increased mean systolic blood pressure (SBP) during the second hour and tended to increase mean SBP during the third hour. Mean diastolic blood pressure in S was significantly lower than the other trials during the first and second hours, and mean arterial pressure was significantly lower in S compared to the LC, LC + S, HC, and HC + S trials. No differences were observed in HR. Consumption of p‐synephrine may acutely reduce diastolic blood pressure and mean arterial pressure and not affect SBP or HR during quiet sitting. The addition of p‐synephrine to caffeine did not augment SBP or HR indicating that consumption of up to 104 mg of p‐synephrine does not induce cardiovascular stress during quiet sitting.     

The effects of wheat germ supplementation on metabolic profile in patients with type 2 diabetes mellitus: A randomized,double‐blind,placebo‐controlled trial

The aim of the present trial was to examine the effects of wheat germ (WG) consumption on metabolic control and oxidative stress status of type 2 diabetes mellitus (T2DM) patients. Eighty participants with T2DM were randomly allocated to receive 20‐g WG (n = 40) or placebo (n = 40) in a randomized double‐blind clinical trial for 12 weeks. Serum lipid profiles, glycaemic indices, total antioxidant capacity, and malondialdhyde (MDA) were assessed. A total of 75 subjects completed the trial. Compared with the placebo, WG consumption led to significant reduction in total cholesterol (TC) concentrations (p = .04). There was a trend regarding TC to high density lipoprotein ratio (p = .08) following 12 weeks WG consumption, although they were not statistically significant after correcting for multiple testing. In addition, within‐group comparison revealed a significant rise in total antioxidant capacity concentration (p = .001) in WG group. We observed no significant effects of WG intake on glycaemic status, blood pressure, MDA, triglyceride, and low density lipoprotein levels. WG consumption for 12 weeks could decrease serum TC levels and had no significant effects on other metabolic variables and MDA in patients with T2DM. Though observed health benefit effects were small, it might lead to a major impact on wider public health.