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Objective: The purpose of this study was to evaluate the impact of isoflavone supplementation compared with placebo on endometrial histology and serum estradiol levels in premenopausal women with nonatypical endometrial hyperplasia. Materials and Methods: The present double-blindplacebo-controlled clinical trial was conducted on 100 women with nonatypical endometrial hyperplasia in the age range of 30 to 45 years. Participants were randomly assigned to receive 50 mg of isoflavone (n = 50) or placebos (n = 50) daily for three months. Both groups received the standard treatment of nonatypical endometrial hyperplasia. Endometrial biopsy and blood samples were taken at the baseline and three months after the intervention. The incidence of drug side effects was assessed as well. Results: After three months, 88.4% of isoflavone-administered subjects had a significant histological improvement compared to 68.9% subjects in the placebo group (P=0.02). There were no significant differences between the two groups in the changes of serum estradiol levels and the incidence of drug side effects. Conclusion: The findings of the present study demonstrated that the coadministration of 50 mg of isoflavones and medroxyprogesterone acetate increases the treatment efficacy in women with nonatypical endometrial hyperplasia. Clinical Trial Registration. This trial was registered on the Iranian website for clinical trial registration (https://www.irct.ir/trial/53553).
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Hiperplasia Endometrial , Isoflavonas , Femenino , Humanos , Adulto , Persona de Mediana Edad , Hiperplasia Endometrial/tratamiento farmacológico , Hiperplasia Endometrial/inducido químicamente , Hiperplasia Endometrial/epidemiología , Isoflavonas/efectos adversos , Medroxiprogesterona , Irán , Método Doble Ciego , Estradiol/efectos adversos , Suplementos DietéticosRESUMEN
OBJECTIVE: This study evaluated the effects of melatonin supplementation on parameters of mental health, glycemic control, markers of cardiometabolic risk, and oxidative stress in diabetic hemodialysis (HD) patients. DESIGN: A randomized, double-blind, placebo-controlled clinical trial was conducted in 60 diabetic HD patients, 18-80 years of age. Participants were randomly divided into 2 groups to take either melatonin (2 x 5mg/day) (n = 30) or placebo (n = 30) 1 hour before bedtime for 12 weeks. The effects of melatonin on mental health, metabolic status, and gene expression related to metabolic status were assessed using multiple linear regression adjusting for age and BMI. RESULTS: Melatonin supplementation significantly decreased Pittsburgh Sleep Quality Index (P = .007), Beck Depression Inventory index (P = .001), and Beck Anxiety Inventory index (P = .01) compared with the placebo. Additionally, melatonin administration significantly reduced fasting plasma glucose (ß = -21.77 mg/dL, 95% CI -33.22 to -10.33, P < .001), serum insulin levels (ß = -1.89 µIU/mL, 95% CI -3.34 to -0.45, P = .01), and homeostasis model of assessment-insulin resistance (ß = -1.45, 95% CI -2.10 to -0.80, P < .001), and significantly increased the quantitative insulin sensitivity check index (ß = 0.01, 95% CI 0.007-0.02, P < .001) compared with placebo treated subjects. In addition, melatonin administration resulted in a significant reduction in serum high sensitivity C-reactive protein (ß = -1.92 mg/L, 95% CI -3.02 to -0.83, P = .001) and plasma malondialdehyde (ß = -0.21 µmol/L, 95% CI -0.36 to -0.06, P = .005); also, significant rises in plasma total antioxidant capacity (ß = 253.87 mmol/L, 95% CI 189.18-318.56, P < .001) and nitric oxide levels (ß = 2.99 µmol/L, 95% CI 0.71-5.28, P = .01) were observed compared with the placebo. CONCLUSION: Overall, melatonin supplementation for 12 weeks to diabetic HD patients had beneficial effects on mental health, glycemic control, inflammatory markers, and oxidative stress.
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Enfermedades Cardiovasculares/sangre , Diabetes Mellitus/sangre , Control Glucémico/métodos , Melatonina/farmacología , Salud Mental/estadística & datos numéricos , Estrés Oxidativo/efectos de los fármacos , Diálisis Renal/métodos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Antioxidantes/administración & dosificación , Antioxidantes/metabolismo , Antioxidantes/farmacología , Biomarcadores/sangre , Glucemia , Enfermedades Cardiovasculares/prevención & control , Diabetes Mellitus/psicología , Suplementos Dietéticos , Método Doble Ciego , Femenino , Humanos , Insulina/sangre , Resistencia a la Insulina , Masculino , Melatonina/administración & dosificación , Melatonina/sangre , Persona de Mediana Edad , Diálisis Renal/psicología , Resultado del Tratamiento , Adulto JovenRESUMEN
This study was performed to evaluate the effects of vitamin D and n-3 fatty acids' co-supplementation on markers of cardiometabolic risk in diabetic patients with CHD. This randomised, double-blinded, placebo-controlled trial was conducted among sixty-one vitamin D-deficient diabetic patients with CHD. At baseline, the range of serum 25-hydroxyvitamin D levels in study participants was 6·3-19·9 ng/ml. Subjects were randomly assigned into two groups either taking 50 000 IU vitamin D supplements every 2 weeks plus 2× 1000 mg/d n-3 fatty acids from flaxseed oil (n 30) or placebo (n 31) for 6 months. Vitamin D and n-3 fatty acids' co-supplementation significantly reduced mean (P = 0·01) and maximum levels of left carotid intima-media thickness (CIMT) (P = 0·004), and mean (P = 0·02) and maximum levels of right CIMT (P = 0·003) compared with the placebo. In addition, co-supplementation led to a significant reduction in fasting plasma glucose (ß -0·40 mmol/l; 95 % CI -0·77, -0·03; P = 0·03), insulin (ß -1·66 µIU/ml; 95 % CI -2·43, -0·89; P < 0·001), insulin resistance (ß -0·49; 95 % CI -0·72, -0·25; P < 0·001) and LDL-cholesterol (ß -0·21 mmol/l; 95 % CI -0·41, -0·01; P = 0·04), and a significant increase in insulin sensitivity (ß +0·008; 95 % CI 0·004, 0·01; P = 0·001) and HDL-cholesterol (ß +0·09 mmol/l; 95 % CI 0·01, 0·17; P = 0·02) compared with the placebo. Additionally, high-sensitivity C-reactive protein (ß -1·56 mg/l; 95 % CI -2·65, -0·48; P = 0·005) was reduced in the supplemented group compared with the placebo group. Overall, vitamin D and n-3 fatty acids' co-supplementation had beneficial effects on markers of cardiometabolic risk.
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Enfermedad Coronaria/complicaciones , Diabetes Mellitus Tipo 2/sangre , Suplementos Dietéticos , Ácidos Grasos Omega-3/administración & dosificación , Vitamina D/administración & dosificación , Anciano , Biomarcadores/sangre , Glucemia/metabolismo , Diabetes Mellitus Tipo 2/complicaciones , Método Doble Ciego , Femenino , Humanos , Insulina/sangre , Masculino , Persona de Mediana Edad , Placebos , Factores de Riesgo , Vitamina D/análogos & derivados , Vitamina D/sangre , Deficiencia de Vitamina D/complicacionesRESUMEN
This systematic review and meta-analysis of randomized controlled trials was performed to determine the effect of quercetin supplementation on glycemic control among patients with metabolic syndrome and related disorders. Databases including PubMed, MEDLINE, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials were searched until August 30, 2018. Nine studies with 10 effect sizes out of 357 selected reports were identified eligible to be included in current meta-analysis. The pooled findings indicated that quercetin supplementation did not affect fasting plasma glucose (FPG), homeostasis model of assessment-estimated insulin resistance, and hemoglobin A1c levels. In subgroup analysis, quercetin supplementation significantly reduced FPG in studies with a duration of ≥8 weeks (weighted mean difference [WMD]: -0.94; 95% confidence interval [CI; -1.81, -0.07]) and used quercetin in dosages of ≥500 mg/day (WMD: -1.08; 95% CI [-2.08, -0.07]). In addition, subgroup analysis revealed a significant reduction in insulin concentrations following supplementation with quercetin in studies that enrolled individuals aged <45 years (WMD: -1.36; 95% CI [-1.76, -0.97]) and that used quercetin in dosages of ≥500 mg/day (WMD: -1.57; 95% CI [-1.98, -1.16]). In summary, subgroup analysis based on duration of ≥8 weeks and used quercetin in dosages of ≥500 mg/day significantly reduced FPG levels.
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Glucemia/efectos de los fármacos , Suplementos Dietéticos/análisis , Síndrome Metabólico/tratamiento farmacológico , Quercetina/uso terapéutico , Humanos , Síndrome Metabólico/patología , Persona de Mediana Edad , Quercetina/farmacología , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
In the article, the name of the co-author was given incorrectly. The correct name of the author is Mohammad Ali Mansournia. In the abstract section the correct abbreviation of "mean difference" is MD.
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This systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to clarify the effect of melatonin supplementation on glycemic control. Databases including PubMed, MEDLINE, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials were searched until July 30th, 2018. Two reviewers independently assessed study eligibility, extracted data, and evaluated the risk of bias for included trials. Heterogeneity among included studies was assessed using Cochran's Q test and I-square (I2) statistic. Data were pooled using random-effect models and standardized mean difference (MD) was considered as the overall effect size. Twelve trials out of 292 selected reports were identified eligible to be included in current meta-analysis. The pooled findings indicated that melatonin supplementation significantly reduced fasting glucose (SMD=-6.34; 95% CI, -12.28, -0.40; p=0.04; I2: 65.0) and increased the quantitative insulin sensitivity check index (QUICKI) (SMD=0.01; 95% CI, 0.00, 0.02; p=0.01; I2: 0.0). However, melatonin administration did not significantly influence insulin levels (SMD=-1.03; 95% CI, -3.82, 1.77; p=0.47; I2: 0.53), homeostasis model assessment of insulin resistance (HOMA-IR) (SMD=-0.34; 95% CI, -1.25, 0.58; p=0.37; I2: 0.37) or HbA1c levels (SMD=-0.22; 95% CI, -0.47, 0.03; p=0.08; I2: 0.0). In summary, the current meta-analysis showed a promising effect of melatonin supplementation on glycemic control through reducing fasting glucose and increasing QUICKI, yet additional prospective studies are recommended, using higher supplementation doses and longer intervention period, to confirm the impact of melatonin on insulin levels, HOMA-IR and HbA1c.
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Glucemia/metabolismo , Diabetes Mellitus/tratamiento farmacológico , Melatonina/administración & dosificación , Diabetes Mellitus/metabolismo , Suplementos Dietéticos/análisis , Humanos , Resistencia a la Insulina , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
In this systematic review and meta-analysis of randomized controlled trials (RCTs), the effects of vitamin D supplementation on biomarkers of inflammation and oxidative stress in diabetic patients are summarized. The following databases were searched up to December 2017: MEDLINE, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials. The quality of the relevant extracted data was assessed according to the Cochrane risk of bias tool. Data were pooled using the inverse variance method and expressed as mean difference with 95% Confidence Intervals (95% CI). Heterogeneity between studies was assessed by the Cochran Q statistic and I-squared tests (I2). Overall, 33 studies were included in the meta-analyses. Vitamin D supplementation were found to significantly reduce serum high-sensitivity C-reactive protein (hs-CRP) (WMD 0.27; 95% CI, - 0.35, - 0.20; p<0.001) and malondialdehyde (MDA) levels (WMD - 0.43, 95% CI - 0.62, - 0.25, p<0.001) in diabetic patients. In addition, vitamin D supplementation were found to increase markers of nitric oxide (NO) release (WMD 4.33, 95% CI 0.96, 7.70), total serum antioxidant capacity (TAC) (WMD 57.34, 95% CI 33.48, 81.20, p<0.001) and total glutathione (GSH) levels (WMD 82.59, 95% CI 44.37, 120.81, p<0.001). Overall, this meta-analysis shows that in diabetic patients, taking vitamin D had significant effects on hs-CRP and MDA levels, and significantly increased NO, TAC and GSH levels.
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Biomarcadores/metabolismo , Diabetes Mellitus/tratamiento farmacológico , Diabetes Mellitus/patología , Suplementos Dietéticos , Inflamación/patología , Estrés Oxidativo , Vitamina D/uso terapéutico , Adulto , Anciano , Antioxidantes/metabolismo , Proteína C-Reactiva/metabolismo , Glutatión/metabolismo , Humanos , Malondialdehído/metabolismo , Persona de Mediana Edad , Óxido Nítrico/metabolismo , Sesgo de Publicación , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Vitamina D/farmacologíaRESUMEN
The current systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to summarize the effect of vitamin D supplementation on biomarkers of inflammation and oxidative stress among women with polycystic ovary syndrome (PCOS). Cochrane library, Embase, PubMed, and Web of Science database were searched to identify related randomized-controlled articles (RCTs) published up to November 2017. Two researchers assessed study eligibility, extracted data, and evaluated risk of bias of included RCTs, independently. To check heterogeneity Q-test and I2 statistics were used. Data were pooled by using the random-effect model and standardized mean difference (SMD) was considered as summary effect size. Seven RCTs were included into our meta-analysis. The findings showed that vitamin D supplementation in women with PCOS significantly decreased high-sensitivity C-reactive protein (hs-CRP) (SMD -1.03; 95% CI, -1.58, -0.49; p <0.001) and malondialdehyde (MDA) (SMD -1.64, 95% CI -2.26 to -1.02, p <0.001), and significantly increased total antioxidant capacity (TAC) levels (SMD 0.86, 95% CI 0.08 to 1.64, p=0.03). Vitamin D supplementation had no significant effect on nitric oxide (NO) (SMD 0.11, 95% CI -0.44 to 0.66, p=0.69) and total glutathione (GSH) levels (SMD 0.54, 95% CI -0.20 to 1.28, p=0.15). Overall, the current meta-analysis demonstrated that vitamin D supplementation to women with PCOS resulted in an improvement in hs-CRP, MDA and TAC, but did not affect NO and GSH levels.
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Biomarcadores/sangre , Suplementos Dietéticos , Inflamación/sangre , Inflamación/tratamiento farmacológico , Estrés Oxidativo/efectos de los fármacos , Síndrome del Ovario Poliquístico/sangre , Vitamina D/administración & dosificación , Femenino , Humanos , Inflamación/etiología , Síndrome del Ovario Poliquístico/complicaciones , Síndrome del Ovario Poliquístico/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Vitaminas/administración & dosificaciónRESUMEN
BACKGROUND: The aim of this clinical trial was to determine the effects of melatonin administration on disease severity and sleep quality in children diagnosed with atopic dermatitis (AD). METHODS: This randomized, double-blinded, placebo-controlled trial was conducted by recruiting 70 patients, aged 6-12 years, who had been diagnosed with AD. Study participants were randomly allocated into two intervention groups to receive either 6 mg/d melatonin supplements or placebo (n = 35 each group) for 6 weeks. Severity of disease was assessed using the scoring atopic dermatitis (SCORAD) and objective SCORAD indices. Sleep quality was evaluated by completing the Children's Sleep Habits Questionnaire (CSHQ). RESULTS: Following 6 weeks of intervention, melatonin supplementation significantly improved SCORAD index (ß -3.55; 95% CI, -6.11, -0.98; P = 0.007), objective SCORAD index (ß -3.23; 95% CI, -5.08, -1.38; P = 0.001), serum total IgE levels (ß -153.94 ku/L; 95% CI, -260.39, -47.49; P = 0.005), and CSHQ scores (ß -2.55; 95% CI, -4.34, -0.75; P = 0.006). However, melatonin had no significant impact on pruritus scores, high-sensitivity C-reactive protein (hs-CRP), sleep-onset latency, total sleep time, weight, and BMI compared with placebo. CONCLUSIONS: Overall, melatonin supplementation had beneficial effects on disease severity, serum total IgE levels, and CSHQ among children diagnosed with AD.
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Dermatitis Atópica/tratamiento farmacológico , Melatonina/administración & dosificación , Sueño/efectos de los fármacos , Niño , Dermatitis Atópica/fisiopatología , Método Doble Ciego , Femenino , Humanos , Inmunoglobulina E/sangre , Irán , Masculino , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
This study was carried out to evaluate the effects of Se supplementation on metabolic profiles in patients with congestive heart failure (CHF). This randomised double-blind, placebo-controlled trial was performed among fifty-three subjects with CHF, aged 45-85 years old. Subjects were randomly allocated into two groups to take either 200 µg/d of Se as Se yeast (n 26) or placebo (n 27) for 12 weeks. Metabolic profiles were assessed at baseline and at the end of trial. Compared with the placebo, Se supplementation led to significant reductions in serum insulin (-18·41 (sd 27·53) v. +13·73 (sd 23·63) pmol/l, P<0·001), homoeostatic model of assessment for insulin resistance (-1·01 (sd 1·61) v. +0·55 (sd 1·20), P<0·001) and a significant increase in quantitative insulin sensitivity check index (QUICKI) (+0·007 (sd 0·03) v. -0·01 (sd 0·01), P=0·007). In addition, Se supplementation significantly decreased LDL-cholesterol (-0·23 (sd 0·29) v. -0·04 (sd 0·28) mmol/l, P=0·03) and total-:HDL-cholesterol ratio (-0·47 (sd 0·31) v. -0·06 (sd 0·42), P<0·001), and significantly increased HDL-cholesterol levels (+0·18 (sd 0·19) v. +0·02 (sd 0·13) mmol/l, P=0·001) compared with the placebo. In addition, taking Se supplements was associated with a significant reduction in high-sensitivity C-reactive protein (hs-CRP) (-1880·8 (sd 3437·5) v. +415·3 (sd 2116·5) ng/ml, P=0·01), and a significant elevation in plasma total antioxidant capacity (TAC) (+30·9 (sd 118·0) v. -187·9 (sd 412·7) mmol/l, P=0·004) and total glutathione levels (+33·7 (sd 130·4) v. -39·2 (sd 132·8) µmol/l, P=0·003) compared with the placebo. When we applied Bonferroni correction for multiple outcome testing, QUICKI (P=0·11), LDL-cholesterol (P=0·51), hs-CRP (P=0·17), TAC (P=0·06) and GSH (P=0·05) became non-significant, and other metabolic profiles did not alter. Overall, our study supported that Se supplementation for 12 weeks to patients with CHF had beneficial effects on insulin metabolism and few markers of cardio-metabolic risk.
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Suplementos Dietéticos , Insuficiencia Cardíaca/terapia , Selenio/uso terapéutico , Anciano , Anciano de 80 o más Años , Antropometría , Enfermedades Cardiovasculares/metabolismo , Dieta , Método Doble Ciego , Femenino , Humanos , Insulina/sangre , Resistencia a la Insulina , Lipoproteínas LDL/metabolismo , Masculino , Persona de Mediana Edad , Factores de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: Several studies have evaluated the effect of inositol supplementation on lipid profiles among population with metabolic diseases; however, the findings are controversial. This review of randomized controlled trials (RCTs) was performed to summarize the evidence of the effects of inositol supplementation on lipid profiles among population with metabolic diseases. METHODS: Relevant RCTs studies were searched in Cochrane Library, EMBASE, MEDLINE, and Web of Science until October 2017. Two researchers assessed study eligibility, extracted data, and evaluated risk of bias of included primary studies, independently. To check for the heterogeneity among included studies Q-test and I2 statistics were used. Data were pooled by using the random-effect model and standardized mean difference (SMD) was considered as summary of the effect size. RESULTS: Overall, 14 RCTs were included into meta-analysis. Pooled results showed that inositol supplementation among patients with metabolic diseases significantly decreased triglycerides (SMD - 1.24; 95% CI, - 1.84, - 0.64; P < 0.001), total- (SMD - 1.09; 95% CI, - 1.83, - 0.55; P < 0.001), and LDL-cholesterol levels (SMD - 1.31; 95% CI, - 2.23, - 0.39; P = 0.005). There was no effect of inositol supplementation on HDL-cholesterol levels (SMD 0.20; 95% CI, - 0.27, 0.67; P = 0.40). CONCLUSIONS: Inositol supplementation may result in reduction in triglycerides, total- and LDL-cholesterol levels, but did not affect HDL-cholesterol levels among patients with metabolic diseases. Additional prospective studies regarding the effect of inositol supplementation on lipid profiles in patients with metabolic diseases are necessary.
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LDL-Colesterol/sangre , Suplementos Dietéticos , Inositol/administración & dosificación , Enfermedades Metabólicas/dietoterapia , Triglicéridos/sangre , Adulto , HDL-Colesterol/sangre , LDL-Colesterol/antagonistas & inhibidores , Femenino , Humanos , Metabolismo de los Lípidos/efectos de los fármacos , Masculino , Enfermedades Metabólicas/sangre , Enfermedades Metabólicas/patología , Metaboloma/efectos de los fármacos , Persona de Mediana Edad , Oportunidad Relativa , Ensayos Clínicos Controlados Aleatorios como Asunto , Triglicéridos/antagonistas & inhibidoresRESUMEN
OBJECTIVE: This systematic review and meta-analysis of randomized controlled trials (RCTs) was carried out to determine the effect of melatonin supplementation on the inflammatory markers among individuals with metabolic syndrome (MetS) and related disorders. METHODS: We searched the following databases up to March 2018: PubMed, MEDLINE, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials. Three reviewers independently assessed study eligibility, extracted data, and evaluated risk of bias of included primary studies. Statistical heterogeneity was assessed using Cochran's Q test and I-square (I2) statistic. Data were pooled using the random effect model and standardized mean difference (SMD) was considered as the summary effect size. RESULTS: Six trials of 317 potential reports were identified to be suitable for our meta-analysis. The pooled results using random effects model indicated that melatonin supplementation significantly reduced C-reactive protein (CRP) (SMD = - 1.80; 95% CI - 3.27, - 0.32; P = 0.01; I2: 95.2) and interleukin 6 (IL-6) concentrations (SMD = - 2.02; 95% CI - 3.57, - 0.47; P = 0.01; I2: 91.2) among patients with MetS and related disorders; however, it did not affect tumor necrosis factor-α (TNF-α) concentrations (SMD = - 1.87; 95% CI - 3.81, 0.07; P = 0.05; I2: 94.4). CONCLUSIONS: In summary, the current meta-analysis showed the promising effect of melatonin administration on reducing CRP and IL-6, but not TNF-α levels among patients with MetS and related disorders. Additional prospective studies are recommended using higher supplementation doses and longer intervention period.
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Inflamación/tratamiento farmacológico , Melatonina/administración & dosificación , Síndrome Metabólico/tratamiento farmacológico , Biomarcadores/metabolismo , Proteína C-Reactiva/metabolismo , Suplementos Dietéticos , Humanos , Inflamación/fisiopatología , Interleucina-6/metabolismo , Síndrome Metabólico/fisiopatología , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
The purpose of the present clinical trial was to determine the impact of zinc supplementation on serum liver enzymes, steatosis severity, lipid profile, and inflammatory status in overweight or obese children with nonalcoholic steatohepatitis (NASH). This randomized controlled trial was conducted by enrolling 60 children with NASH, aged 10-18 years old. The participants were randomly assigned to two groups that received either 30 mg/day of elemental zinc or placebo for 16 weeks. The severity of liver steatosis was evaluated using liver ultrasonography. Fasting blood samples were collected from each patient at the beginning and after 16 weeks of intervention to measure biochemical parameters. Following a 16-week intervention, zinc supplementation compared with placebo significantly decreased serum alanine aminotransferase (ALT) concentrations and high-sensitivity C-reactive protein and considerably enhanced HDL-cholesterol values. However, zinc intake had no considerable impact on aspartate aminotransferase, the severity of liver steatosis, anthropometric parameters, and other lipid indices versus the placebo group. Overall, zinc supplementation showed a promising impact on serum ALT, HDL-cholesterol, and inflammatory status in overweight or obese children suffering from NASH. Zinc supplementation may be a new strategy for the amelioration of NASH in overweight or obese children. This trial has been registered on the Iranian website for registration of clinical trials with the special ID of IRCT20200531047614N1 ( https://www.irct.ir/trial/48543 ).
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Background: This investigation was performed to assess the effects of alpha-lipoic acid (ALA) supplementation on psychological status and markers of inflammation and oxidative damage in patients with type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD). Methods: This randomized, double-blind, placebo-controlled trial was performed in 60 patients with T2DM and CHD, aged 45-85 years. Patients were randomized into two groups to receive either 600 mg/day ALA (n = 30) or placebo (n = 30) for 12 weeks. Results: ALA supplementation significantly decreased Beck Depression Inventory index (BDI) (-5.1 ± 3.5 vs. -1.1 ± 4.8, P = 0.001) when compared with the placebo. ALA supplementation resulted also in a significant reduction of serum high sensitivity C-reactive protein (hs-CRP) (-0.8 ± 1.4 vs. +0.5 ± 0.6 mg/L, P < 0.001) and malondialdehyde (MDA) (-0.3 ± 0.2 vs. -0.1 ± 0.3 µmol/L, P = 0.003), and a significant increase in plasma total antioxidant capacity (TAC) levels (+ 26.8 ± 36.0 vs. -4.6 ± 43.4 mmol/L, P = 0.007) when compared with the placebo. ALA intake upregulated transforming growth factor beta (TGF-ß) (P = 0.03) and downregulated gene expression of interleukin-1 (IL-1) (P = 0.001) in peripheral blood mononuclear cells of patients with T2DM and CHD as well. Conclusions: ALA supplementation for 12 weeks in patients with T2DM and CHD had beneficial effects on BDI, hs-CRP, TAC, MDA values, and gene expression of IL-1 and TGF-ß. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-022-01031-1.
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The purpose of this systematic review and meta-analysis of randomized controlled trials (RCTs) is to determine the effectiveness of probiotic supplementation on clinical symptoms, weight loss, glycemic control, lipid and hormonal profiles, and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome (PCOS). Eligible studies were systematically searched from Cochrane Library, Embase, Medline, and Web of Science databases until January 2019. Cochran (Q) and I-square statistics were used to measure heterogeneity among included studies. Data were pooled by using random-effect model and expressed as standardized mean difference (SMD) with 95% confidence interval (CI). Eleven articles were included in this meta-analysis. Probiotic supplementation significantly decreased weight (SMD - 0.30; 95% CI, - 0.53, - 0.07; P = 0.01), body mass index (BMI) (SMD - 0.29; 95% CI, - 0.54, - 0.03; P = 0.02), fasting plasma glucose (FPG) (SMD - 0.26; 95% CI, - 0.45, - 0.07; P < 0.001), insulin (SMD - 0.52; 95% CI, - 0.81, - 0.24; P < 0.001), homeostatic model assessment for insulin resistance (HOMA-IR) (SMD - 0.53; 95% CI, - 0.79, - 0.26; P < 0.001), triglycerides (SMD - 0.69; 95% CI, - 0.99, - 0.39; P < 0.001), VLDL-cholesterol (SMD - 0.69; 95% CI, - 0.99, - 0.39; P < 0.001), C-reactive protein (CRP) (SMD - 1.26; 95% CI, - 2.14, - 0.37; P < 0.001), malondialdehyde (MDA) (SMD - 0.90; 95% CI, - 1.16, - 0.63; P < 0.001), hirsutism (SMD - 0.58; 95% CI, - 1.01, - 0.16; P < 0.001), and total testosterone levels (SMD - 0.58; 95% CI, - 0.82, - 0.34; P < 0.001), and also increased the quantitative insulin sensitivity check index (QUICKI) (SMD 0.41; 95% CI, 0.11, 0.70; P < 0.01), nitric oxide (NO) (SMD 0.33; 95% CI 0.08, 0.59; P = 0.01), total antioxidant capacity (TAC) (SMD 0.64; 95% CI, 0.38, 0.90; P < 0.001), glutathione (GSH) (SMD 0.26; 95% CI, 0.01, 0.52; P = 0.04), and sex hormone binding globulin (SHBG) levels (SMD 0.46; 95% CI, 0.08, 0.85; P = 0.01). Probiotic supplementation may result in an improvement in weight, BMI, FPG, insulin, HOMA-IR, triglycerides, VLDL-cholesterol, CRP, MDA, hirsutism, total testosterone, QUICKI, NO, TAC, GSH, and SHBG but did not affect dehydroepiandrosterone sulfate levels, and total, LDL, and HDL cholesterol levels in patients with PCOS.
Asunto(s)
Síndrome del Ovario Poliquístico , Probióticos , Biomarcadores/metabolismo , Suplementos Dietéticos , Femenino , Control Glucémico , Humanos , Inflamación/metabolismo , Estrés Oxidativo , Síndrome del Ovario Poliquístico/tratamiento farmacológico , Síndrome del Ovario Poliquístico/metabolismo , Probióticos/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Triglicéridos , Pérdida de PesoRESUMEN
Objectives: Deformation of the skull by external forces in the absence of synostosis has been defined as positional plagiocephaly (PP). The aim of this investigation was to determine the risk factors of PP in healthy Iranian infants. Materials & Methods: This case-control study was performed on 300 healthy Iranian infants aged 8-12 weeks who were referred to the pediatric neurology clinic at Shahid Beheshti Hospital of Kashan. Plagiocephaly evaluations were done using Argenta's scale. Results: Based on multivariate logistic regression analysis, there was a significant association between PP and male gender (OR=2.26; P=0.002), head circumference (OR=1.22; P=0.006), multiple pregnancy (OR=2.55; P=0.03), abnormal presentation in uterine (OR=2.18; P=0.02), primiparity (OR=2.43; P=0.003), and supine sleep position (OR=2.97; P<0.001). However, type of delivery, firmness of headrest, oligohydramnios, and prolonged labor were not correlated with PP. Conclusions: The current investigation supports the idea that head circumference, male gender, primiparity, multiple pregnancy, supine sleep position, and abnormal presentation in the uterine are correlated with a greater incidence of PP. Further investigations should be undertaken to understand PP and its related risk factors fully.
RESUMEN
An amendment to this paper has been published and can be accessed via a link at the top of the paper.