Effect of Zingiber officinale on Lipid Profile and Some Inflammatory Markers in Diabetic Hemodialysis Patients: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

Background: Diabetes, inflammation, and abnormal lipid levels are the main risk factors for mortality in end-stage renal disease (ESRD). The present study aimed to investigate the effects of ginger supplementation on inflammatory markers and lipid profile in diabetic patients with ESRD undergoing hemodialysis. Methods: In this study, 44 patients were randomly assigned to either the ginger or the placebo group. The patients in the ginger group received 2000 mg/d ginger for eight weeks, while the control group received the placebo with the same protocol. The serum concentrations of triglyceride (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-c), high-density lipoprotein-cholesterol (HDL-c), albumin, and high-sensitivity C-reactive protein (hs-CRP) were measured after a 12- to 14-hours fast at the baseline and the end of the study, as along with the platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and Glasgow prognostic score (GPS). Results: Forty-one subjects were analyzed based on the intention-to-treat method of all included patients. Serum levels of TG (p=0.003), hs-CRP (p=0.022), and NLR (p=0.001) decreased significantly in the ginger group compared to the placebo group, while albumin concentration in serum was elevated (p=0.022). However, there were no significant differences in GPS, levels of TC, LDL-C, HDL-C, and PLR within and between the groups (p > 0.05). Conclusion: Ginger administration reduced NLR, hs-CRP, and TG serum levels and increased serum albumin levels in included patients. Thus, ginger can be considered an effective complementary treatment for these patients. This trail is registered with IRCT20191109045382N3.

Renoprotective effects of the ginger (Zingiber officinale) on Diabetic kidney disease, current knowledge and future direction: a systematic review of animal studies.

OBJECTIVE: Diabetic kidney disease affects approximately 40% of diabetic patients and is the leading cause of chronic kidney disease (CKD) worldwide. As a result, preventing renal complications in diabetic patients is critical. Ginger (Zingiber Officinale Rosco) is a popular spice and natral medicine. The present study was a systematic review focused on the existing evidence of the renoprotective effect of ginger extract on some features of diabetic kidney disease. METHODS: The literature was searched in online databases such as PubMed, Scopus, EMBASE, ProQuest databases, and Google Scholar from inception to July 2022. RESULTS: This review included 41 articles that met the eligibility criteria. Ginger supplementation was found to be associated with a significant decrease in blood glucose in 28 studies. Nine studies showed a significant reduction in malondialdehyde (MDA) after supplementation. Also, seventeen studies showed decreased serum levels of creatinine. Fifteen studies reported a decrease in total cholesterol (TC) and fourteen studies showed a lowered triglycerides (TG) concentrations. In twenty-six studies, ginger reduced renal injuries due to diabetes. CONCLUSION: Ginger may improve blood sugar indices, lipid profile, some inflammatory markers, oxidative stress, and pathologic injuries in diabetic kidney disease. However, future well-designed clinical trials and meta-analyses are required for a solid consensus.

Vitamin D supplementation positively affects anthropometric indices: Evidence obtained from an umbrella meta-analysis.

Despite the growing evidence from meta-analyses on vitamin D's anti-obesity properties, their results are controversial. The current umbrella review was performed to assess the available evidence and provide a conclusive explanation in this regard. The international databases PubMed, Scopus, Embase, Web of Science and Google Scholar were systematically searched till March, 2022. A random-effects model was used to run the meta-analysis. All meta-analyses that examined the effect of vitamin D supplementation on BW, BMI, WC, and fat mass were included. Findings of 14 meta-analyses revealed that vitamin D supplementation reduced body mass index (BMI) (ES: -0.11 kg/m2; 95% CI: -0.18, -0.05, p?0.001; I 2 = 61.0%, p < 0.001), and waist circumference (WC) (ES = -0.79 cm; 95% CI: -1.20, -0.37; p < 0.001; I 2 = 46.5%, p = 0.096) in comparison to control group. However, the effects of vitamin D on body weight (ES = -0.16 kg, 95% CI: -0.36, 0.04; p = 0.125; I 2 = 57.0%, p = 0.017), and fat mass (ES: 0.02, 95% CI: -0.20, 0.24, p = 0.868; I 2 = 0.0%, p = 0.531) were not considerable. Vitamin D supplementation significantly improved levels of obesity indices such as BMI, and WC.

Inositol supplementation and body mass index: A systematic review and meta-analysis of randomized clinical trials.

Background: Inositol is a sugar-alcohol and recognized as a key component of cell membrane phospholipids. It has crucial role in the cell signaling pathways and contribute to improving glycemic responses. Although some earlier studies have revealed the effect of inositol mediating glucose uptake by improving insulin sensitivity, the benefit of inositol supplementation in patients with overweight and obesity is not completely understood. This study aimed to assess the impact of inositol supplementation on body mass index (BMI) through a systematic review and meta-analysis of controlled clinical trials. Methods: A systematic search was performed to August 2021 in the following databases: PubMed-Medline, Embase, Web of Science and Scopus. Fifteen controlled clinical trials investigating the effect of inositol on adult's BMI were finally included in the study. A random-effects model was employed to estimate the effect size. Subgroup analysis was performed by dose, duration, age, type of inositol. Meta-regression was used to investigate presence of any linear relationship. Begg's and Egger's tests were carried out to detect small study effect. Results: The results of pooled analysis showed that inositol supplementation significantly decreased BMI scores (WMD = -0.41 kg/m2; 95% CI: -0.78, -0.04; p = 0.028). Subgroup analysis was performed to identify the source of heterogeneity among studies (I 2 = 73.9%, p < 0.001), demonstrating supplementation duration, baseline BMI, mean age of participants, type of inositol and dosage were potential sources of heterogeneity. The effect of intervention was more clinically significant in participants with polycystic ovary syndrome (PCOS) and overweight/obesity. Inositol in the form of myo-inositol (MI) had stronger effect on BMI reduction. Conclusion: The meta-analysis suggests that oral inositol supplementation has positive effect on BMI reduction. Inositol supplementation could be considered as an adjunct treatment to improve body mass index.

Anti-obesity properties of probiotics; a considerable medical nutrition intervention: Findings from an umbrella meta-analysis.

Although several studies have indicated that consumption of probiotics is effective in the treatment of obesity, the results in this regard have yielded controversial findings. The current umbrella meta-analysis was performed to evaluate the effects of probiotics supplementation on obesity indices in adults. Scopus, PubMed, Web of Science, Embase and Google Scholar were searched for relevant studies published till November 2021. Meta-analysis was conducted using the random-effects model. Sensitivity and subgroup analyses were performed. In total, 29 meta-analyses with 14,366 participants, including 112, 78, and 38 unique trials for body mass index (BMI), body weight (BW), and waist circumference (WC), were included in the study, respectively. The findings demonstrated that the probiotics supplementation was significantly effective on decreasing of BMI (ES = -0.21; 95% CI: -0.30, -0.13, p < 0.001; I2 = 83.0%, p < 0.001), BW (ES = -0.38, 95% CI: -0.60, -0.16; p < 0.001; I2 = 81.8%, p < 0.001), and WC (ES = -0.60; 95% CI: -0.89, -0.31; p < 0.001; I2 = 89.1%, p < 0.001). Greater effects on BW were observed when intervention duration was >8 weeks and on obese individuals. BMI was also greatly modified in participants with metabolic syndrome and when intervention duration lasted for ≥12 weeks. The methodological quality (AMSTAR2) was moderate in 83%, low in 10%, and critically low in 7% of included studies. The current umbrella meta-analysis indicated that supplementation of probiotics in adults led to a meaningful reduction in BW, BMI, and WC. Therefore, our findings strongly recommend supplementation with probiotics as a potent intervention in the management of obesity.

Melatonin effectiveness in amelioration of oxidative stress and strengthening of antioxidant defense system: Findings from a systematic review and dose-response meta-analysis of controlled clinical trials.

BACKGROUND AND AIM: Oxidative stress is involved in the development of chronic diseases. It has been suggested that melatonin has a protective role against oxidative stress by activation of antioxidant enzymes and scavenging free-radicals. Present study aimed to investigate the effect of melatonin supplementation on oxidative stress and antioxidant biomarkers such as malondialdehyde (MDA), increased total antioxidant capacity (TAC), superoxide dismutase (SOD), and Glutathione peroxidase (GPx). METHODS: Systematic search was performed to identify relevant studies in PubMed/Medline, SCOPUS, Web of Science and Embase databases and Google Scholar up to September 2020. Meta-analysis was conducted using random-effect model. Subgroup analysis and meta-regression was used to identify sources of heterogeneity. The quality of studies was assessed using Cochrane Collaboration's tool. Publication bias was assessed by visual inspection of funnel plot. RESULTS: A total number of 16 eligible articles were included in the meta-analysis. The dosages of melatonin varied between 3 and 400 mg/day, with a duration range between 1.42 and 12 weeks. Melatonin supplementation significantly increased serum levels of TAC [SMD: 1.59; 95% CI: 0.89, 2.29; P < 0.001; (I2 = 93.53%, P < 0.001 No significant effects were observed on MDA [SMD: -3.09; 95% CI: -7.07, 0.89; P = 0.12; (I2 = 99.57%, P < 0.001)], GPx [SMD: 0.86; 95% CI: -3.46, 5.19; P = 0.61; (I2 = 98.17%, P < 0.001)] and SOD levels [SMD: 1.92; 95% CI: -3.57, 7.41; P = 0.35; (I2 = 98.27%, P < 0.001)]. CONCLUSION: Results of the current meta-analysis showed that melatonin supplementation had a significant impact on attenuating of oxidative stress and enhancing antioxidant performance. Melatonin supplementation could be suggested as a safe complementary approach in amelioration of the chronic diseases.

Saffron, as an adjunct therapy, contributes to relieve depression symptoms: An umbrella meta-analysis.

BACKGROUND: Saffron is a traditional herbal medicine that has been used to treat various ailments such as depressive mood. However, the findings of several meta-analyses regarding anti-depressive properties of saffron (Crocus sativus L.) are controversial. The current umbrella meta-analysis was carried out to determine the magnitude and direction of saffron administration on depression. METHODS: Relevant studies were searched in international databases including PubMed, Scopus, EMBASE, Web of Science, and Cochrane Central Library up to June 2021. Meta-analysis studies investigating the effects of saffron on depression were considered to include in the study. Random-effects model was used to perform the meta-analysis. Additional analyses including subgroup and sensitivity analyses were carried out. RESULTS: Overall, 7 meta-analyses were included in the study. The results demonstrated that the consumption of saffron resulted in a significant reduction in BDI scores (ES: -3.87; 95% CI: -5.27, -2.46). However, saffron did not change the HAMD scores (ES: -2.10; 95% CI: -5.05, 0.86, p = 0.164) and mixed scores (HAM-D/BDI/DASS) (ES: 0.02; 95% CI: -0.39, 0.43,p = 0.941). CONCLUSION: Present umbrella meta-analysis demonstrated that saffron intake might contribute to alleviation of depression disorder, however, it cannot be considered as a single therapeutic approach to treat depression.

Clinical efficacy of zinc supplementation in improving antioxidant defense system: A comprehensive systematic review and time-response meta-analysis of controlled clinical trials.

Oxidative stress is a contributing factor to many chronic diseases. It has been investigated that zinc (Zn) may enhance the antioxidant defense. The current dose-response and time-response meta-analysis aims to determine the efficacy of Zn supplementation in improving antioxidant defense. Scopus, PubMed/Medline, Web of Science, and Embase databases were searched systematically up to December 30, 2020. Meta-analysis was performed on human controlled clinical trials using random effects method. To find any source of heterogeneity, subgroup analysis and meta-regression were performed. Trim and fill analysis was used for adjusting the publication bias. To find any non-linear relationship between variables and effect size, dose-response and time-response analyses were performed. Cochrane Collaboration's tool was used for evaluating the quality assessment. A total of 23 controlled clinical trials were analyzed. The range of Zn supplementation duration in various studies was within 4-24 weeks. Zn supplementation did not have beneficial effects on glutathione peroxidase (GPx) activity (SMD = -0.34 U/g; 95% CI: -0.93, 0.25; P = 0.258). There were significant increasing effects of Zn supplementation on glutathione (GSH) (SMD = 1.28 µmol/l; 95% CI: 0.42, 2.14; P = 0.003) and total antioxidant capacity (TAC) levels (SMD = 1.39 mmol/l; 95% CI: 0.44, 2.35; P = 0.004). Zn had ameliorative effects on superoxide dismutase (SOD) activity after elimination of publication bias (SMD: 0.84 U/g; 95% CI: 0.12, 1.56, P < 0.05). Zn could also elevate GSH and TAC levels, plus SOD activity after modifying the publication bias. Finally, Zn had no significant effect on GPx activity.

Lutein supplementation combined with a low-calorie diet in middle-aged obese individuals: effects on anthropometric indices, body composition and metabolic parameters.

Lutein is considered as a major biologically active carotenoid, with potential benefits for obesity and cardiometabolic health. This double-blind, randomised controlled trial aimed to assess whether the consumption of lutein along with a low-calorie diet (LCD) can influence anthropometric indices, body composition and metabolic parameters in obese middle-aged individuals. After a 2-week run-in period with an LCD, forty-eight participants aged 45-65 years were randomly assigned to consume 20 mg/d lutein or placebo along with the LCD for 10 weeks. Dietary intake, anthropometric indices, body composition, lipid profile, glucose homoeostasis parameters, NEFA and appetite sensations were assessed at the beginning and end of the study. After 10 weeks, body weight and waist circumference significantly decreased in both groups, although between-group differences were not significant. There was more of a decrease in the percentage of body fat in the lutein group v. the placebo group. Moreover, the placebo group experienced a significant reduction in fat-free mass (FFM), whereas the lutein group preserved FFM during calorie restriction, although the between-group difference did not reach statistical significance. Visceral fat and serum levels of total cholesterol (TC) and LDL-cholesterol were significantly decreased only in the lutein group, with a statistically significant difference between the two arms only for TC. No significant changes were observed in the TAG, HDL-cholesterol, glucose homoeostasis parameters, NEFA and appetite sensations. Lutein supplementation in combination with an LCD could improve body composition and lipid profile in obese middle-aged individuals.

Mechanistic insights into the effect of lutein on atherosclerosis, vascular dysfunction, and related risk factors: A systematic review of in vivo, ex vivo and in vitro studies.

Lutein is an essential carotenoid commonly consumed in the diet; however, its dietary intake does not usually reach the minimum recommended intake to decrease the incidence of chronic diseases. Experimental and epidemiological evidence suggests an anti-atherosclerotic effect for lutein-rich foods or lutein supplementation. This systematic review aimed to assess the mechanistic pathways of lutein in the prevention of atherosclerosis. Electronic databases, including PubMed, SCOPUS, ProQuest, Embase, and Google Scholar were searched to May 2019. Original studies published in English-language journals that investigated the effects of lutein on atherosclerosis and related risk factors, including lipid profile, hemodynamic, glycemic and inflammatory measurements, and endothelial function indices, were considered. Two reviewers independently extracted data on study characteristics, methods and outcomes. The review protocol has been registered at PROSPERO database of Systematic Reviews (registration number: CRD42019121381). A total of 5818 articles were found in the first phase of the search; from these, 19 met the inclusion criteria: 3 in vitro, 1 ex vivo, 11 animal, and 4 human studies. Nine of ten studies showed positive effects of lutein on endothelial function by reducing blood pressure, arterial thickness, monocyte migration, and vascular smooth muscle cell migration. Twelve studies examined the anti-inflammatory properties of lutein and found a significant decrease in proinflammatory cytokines. Although few studies investigated the anti-hyperlipidemic effects of lutein, three animal studies and one clinical trial found a beneficial effect of lutein on lipid profile. Evidence supports positive effects of lutein on atherosclerosis development and some common risk factors of atherosclerosis, including inflammation and endothelial dysfunction. Further studies focused on the effects of lutein on hyperglycemia, lipid profile, blood pressure and coagulation are required.

Risk factors for paclitaxel-induced peripheral neuropathy in patients with breast cancer.

BACKGROUND: Paclitaxel induced peripheral neuropathy (PIPN) is a major debilitating side effect of paclitaxel in patients with breast cancer with no fully known mechanisms. The aim of the study was to find out the possible risk factors for PIPN. METHODS: Eligible patients with node positive breast cancer undergoing chemotherapy with paclitaxel were assessed. They belonged to an initial randomized controlled trial in which the effectiveness of omega-3 fatty acids in preventing and reducing severity of PIPN was evaluated (protocol ID: NCT01049295). Reduced total neuropathy score (r-TNS) was used for measuring PIPN. All analyses were performed adjusting for intervention effect. The association between age, BMI, BSA, pathological grade, molecular biomarkers and PIPN was evaluated. RESULTS: Fifty-seven patients with breast cancer were investigated. Age was significantly associated with risk of PIPN (RR:1.50, P value = .024). Body mass index and BSA had significant association with severity of PIPN (B:1.28, P = .025; and B: 3.88, P = .010 respectively). Also, BSA showed a significant association with the risk of PIPN (RR: 2.28, P = .035; B: 3.88, P = .035). Incidence and severity of PIPN were much more pronounced in progesterone receptor positive (PR+) patients (RR:1.88, P = .015 and B:1.54, P = .012). Multivariate analysis showed that age and the status of PR+ were independent risk factor for incidence and the status of PR+ was the only independent risk factor for severity of PIPN. CONCLUSION: Age, BSA and the status of PR+, should be considered as the risk factors for PIPN before commencement of chemotherapy with paclitaxel in patients with breast cancer. Older patients, those with greater BSA and PR+ patients may need closer follow up and more medical attention due to greater incidence and severity of PIPN.

The effect of n-3 polyunsaturated fatty acids on incidence and severity of oxaliplatin induced peripheral neuropathy: a randomized controlled trial.

BACKGROUND: Oxaliplatin induced peripheral neurotoxicity (OXIPN) is the major dose-limiting and long-lasting side effect of oxaliplatin. N-3 PUFAs have neuroprotective property via their effects on voltage-gated ion channels and by reducing the production of proinflammatory cytokines that causes neuropathy. This study was a randomized double blind placebo controlled trial to find the possible advantages of n-3 PUFAs for preventing and reducing the severity of OXIPN in patients with colon cancer. METHODS: Eligible patients with colon cancer randomly allocated to take n-3 PUFAs pearls, 640 mg t.i.d during chemotherapy with oxaliplatin and one month after the cessation of the treatment or placebo. All patients were evaluated for incidence and severity of OXIPN based on "reduced Total Neuropathy Score" in which clinical and electrophysiological assessments were included. RESULTS: Seventeen patients (47 %) of the n-3 PUFA supplemented group (n = 36) did not develop PN while it was 11 %(4 patients) in the placebo group (n = 35). There was a significant difference in PN incidence (OR = 0.14, .95 % CI = (0.04 to 0.49), p = 0.002). The difference of OXIPN severity was significant between the two study groups (B = -1.61, 0.95 % CI = (-2.59 to -0.62), p = 0.001). CONCLUSIONS: N-3 PUFAs may have neuroprotective effect for reducing the incidence and severity of OXIPN. Finding an effective prophylactic or symptomatic therapy for OXIPN would significantly improve the patients' quality of life. TRIAL REGISTRATION: IRCT201112158397N2.

Influence of chemotherapy on the lipid peroxidation and antioxidant status in patients with acute myeloid leukemia.

Chemotherapeutic agents used in patients with cancer cause to generate the enormous amounts of free radicals associated with cell injury. In this study we assess the effects of chemotherapy regimen on oxidant/antioxidant status in patients with acute myeloid leukemia (AML). 38 newly diagnosed patients with acute myeloid leukemia were recruited in this study. All patients received cytarabine and daunorubicin as chemotherapy regimen. Plasma levels of malondialdehyde (MDA), total antioxidant status (TAS), and the levels of erythrocyte activity of superoxide dismutase (SOD) and glutathione peroxidase (GPx) were determined before chemotherapy and 14 days after chemotherapy with cytarabine and daunorubicin. Plasma MDA concentrations increased significantly (from 2.68 ± 0.89 nmol/L to 3.14 ± 1.29 nmol/L) during the 14 days post-chemotherapy period (P=0.04). Plasma TAS concentrations changed with chemotherapy from 1.09 ± 0.15 mmol/L to 1.02 ± 0.14 mmol/L with P=0.005. Erythrocyte SOD and GPX activity decreased overtime from 1157.24 ± 543.61 U/g Hb to 984.01 ± 419.09 U/g Hb (P=0.04) and 46.96 ± 13.70 U/g Hb to 41.40 ± 6.44 U/g Hb (P=0.02) respectively. We report here that there is an increase in malondialdehyde levels and a decrease in the levels of antioxidant enzymes and total antioxidant status. This suggests that chemotherapy causes these changes as a result of enormous production of reactive oxygen species in the patients with AML. Antioxidant supplementation must be approached with caution because of the probability of reduction the therapeutic efficacy of these cytotoxic drugs.

Omega-3 fatty acids are protective against paclitaxel-induced peripheral neuropathy: a randomized double-blind placebo controlled trial.

BACKGROUND: Axonal sensory peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Omega-3 fatty acids have beneficial effects on neurological disorders from their effects on neurons cells and inhibition of the formation of proinflammatory cytokines involved in peripheral neuropathy. METHODS: This study was a randomized double blind placebo controlled trial to investigate the efficacy of omega-3 fatty acids in reducing incidence and severity of paclitaxel-induced peripheral neuropathy (PIPN). Eligible patients with breast cancer randomly assigned to take omega-3 fatty acid pearls, 640 mg t.i.d during chemotherapy with paclitaxel and one month after the end of the treatment or placebo. Clinical and electrophysiological studies were performed before the onset of chemotherapy and one month after cessation of therapy to evaluate PIPN based on "reduced Total Neuropathy Score". RESULTS: Twenty one patients (70%) of the group taking omega-3 fatty acid supplement (n = 30) did not develop PN while it was 40.7%( 11 patients) in the placebo group(n = 27). A significant difference was seen in PN incidence (OR = 0.3, .95% CI = (0.10-0.88), p = 0.029). There was a non-significant trend for differences of PIPN severity between the two study groups but the frequencies of PN in all scoring categories were higher in the placebo group (0.95% CI = (-2.06 -0.02), p = 0.054). CONCLUSIONS: Omega-3 fatty acids may be an efficient neuroprotective agent for prophylaxis against PIPN. Patients with breast cancer have a longer disease free survival rate with the aid of therapeutical agents. Finding a way to solve the disabling effects of PIPN would significantly improve the patients' quality of life. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov (NCT01049295).