Assessing the predictive value of insulin resistance indices for metabolic syndrome risk in type 2 diabetes mellitus patients.

Limited research has explored the effectiveness of insulin resistance (IR) in forecasting metabolic syndrome (MetS) risk, especially within the Iranian population afflicted with type 2 diabetes mellitus (T2DM). The present investigation aimed to assess the efficacy of IR indices in predicting the risk of MetS among T2DM patients. Convenient sampling was utilized to select four hundred subjects with T2DM. Metabolic factors and IR indices, including the Waist Circumference-Triglyceride Index (WTI), Triglyceride and Glucose Index (TyG index), the product of TyG index and abdominal obesity indices, and the Metabolic Score for Insulin Resistance (METS-IR), were evaluated. Logistic regression, coupled with modeling, was employed to explore the risk of MetS. The predictive performance of the indices for MetS stratified by sex was evaluated via receiver operating characteristic (ROC) curve analysis and estimation of the area under the curve (AUC) values. The TyG-Waist Circumference (TyG-WC) index exhibited the largest AUCs in both males (0.91) and females (0.93), while the TyG-Body Mass Index (TyG-BMI) demonstrated the smallest AUCs (0.77 in males and 0.74 in females). All indices significantly predicted the risk of MetS in all subjects before and after adjustment (p < 0.001 for all). The TyG-WC index demonstrated the highest odds ratios for MetS (8.06, 95% CI 5.41-12.00). In conclusion, all IR indices assessed in this study effectively predicted the risk of MetS among Iranian patients with T2DM, with the TyG-WC index emerging as the most robust predictor across both genders.

The effects of rutin supplement on blood pressure markers, some serum antioxidant enzymes, and quality of life in patients with type 2 diabetes mellitus compared with placebo.

Background: This trial aimed to investigate the effects of rutin supplement in type 2 diabetes mellitus (T2DM) patients. Methods: In this trial with a double-blind and controlled design, fifty patients were randomly divided into intervention (n = 25) and control groups (n = 25) and were treated with 1 g of rutin or placebo for three months, respectively. At the baseline and end of the intervention, mean arterial pressure (MAP), heart rate (HR), pulse pressure (PP), systolic and diastolic blood pressure (SBP and DBP), serum levels of antioxidant enzymes, such as catalase (CAT), glutathione peroxidase (GPx), and superoxide dismutase (SOD) and quality of life (QOL) parameters, were evaluated. Results: Rutin consumption caused a significant reduction in SBP, DBP, PP, MAP, and HR, with a significant increase in SOD, CAT, and GPx and some QOL parameters (emotional limitations, energy and freshness, mental health, social performance, and general health) compared with baseline (p for all <0.05). Also, the mean changes of emotional limitations, energy and freshness, mental health, and general health (unadjusted p for all <0.05) and GPX and SOD (adjusted p for all <0.05) were significantly higher in the rutin group compared with the placebo group. Although, in the supplement group compared with the placebo group, the mean changes of SBP, DBP, MAP, PP, and HR were significantly lower (adjusted p for all <0.05). Conclusion: Rutin consumption improved blood pressure, the levels of antioxidant enzymes, and QOL in patients with T2DM.

Development and Validation of a Simple Equation to Predict Fat-Free Mass in the Adult Population.

Background: Estimating Fat-Free Mass (FFM) is an integral part of Body composition measurements, so obtaining an accurate estimation for evaluating FFM is critical for researchers and specialists. We aimed to develop and validate a simple equation for predicting FFM in the adult population. Methods: Participants were 1996 adults (1085 men and 911 women), and 18 to 69 years old from Ahvaz City, southern Iran. They were randomly divided into the derivation (n=1396) and the validation (n=600) groups with no significant differences from Jan 2018 to Feb 2020. FFM was measured by Bioelectrical Impedance Analyzer (BIA) (InBody 770©; Biospace, Seoul, South Korea). Based on the demographic variables retrieved from the Derivation group, 8 FFM predictive equations were developed using multiple regression; finally, the most accurate model (using the coefficient of determination (R2)) was chosen and then validated on the Validation group for more evaluation. Results: The best equation derived from demographic characteristics was: "FFM= 0.28 × Weight (kg) + 0.57×Height (cm)+7.35×Sex (M=1, F=0)+0.03×Age (years)-70.61"; where sex = 1 for male and 0 for female. R=0.94, R2=0.89, standard error of the estimate=4.04 kg. Conclusion: Our developed and cross-validated anthropometric prediction equation for fat-free mass estimation using BIA attained a high coefficient of determination, a low standard error of the estimate, and the lowermost coefficient of variation. Predictive equations may be reliable and valuable alternative methods for the clinical evaluation of fat-free mass in the adult population.

A case-control study of drinking beverages and the risk of multiple sclerosis in Iran.

BACKGROUND: There is no study in the world on the relationship between consuming black and green tea as beverages containing polyphenols and the risk of MS. This study aimed to determine the association between the consumption of green and black tea, coffee, non-alcoholic beer, milk, fruit juices and carbonated beverages with the risk of MS. METHODS AND MATERIALS: This case-control study was performed on 150 patients with MS and 300 healthy individuals as a control group among patients who were referred to the ophthalmology ward of a referral hospital in Ahvaz with the groups matching for age. The data collection tool was a researcher-made questionnaire including demographic information and beverage consumption. Analysis was performed using univariate and multiple logistic regression models. RESULTS: The mean age of patients at the time of diagnosis was 38.55 ± 8.88 years. The results showed that drinking milk (OR = 5.46), natural juice (OR = 2.49), and carbonated beverages (OR = 16.17) were associated with an increased chance of developing MS. However, drinking non-alcoholic beer (OR = 0.48), black tea (OR = 0.20), green tea (OR = 0.29) and coffee (OR = 0.07) were associated with a reduced chance of developing MS. CONCLUSION: The results show that drinking black and green tea, non-alcoholic beer, and coffee are associated with a decrease in the chance of developing MS. The results of this study can be used to design interventional research and to change people's lifestyles to prevent MS.

The effects of rutin flavonoid supplement on glycemic status, lipid profile, atherogenic index of plasma, brain-derived neurotrophic factor (BDNF), some serum inflammatory, and oxidative stress factors in patients with type 2 diabetes mellitus: A double-blind, placebo-controlled trial.

This study aimed to investigate the effects of rutin flavonoid in type 2 diabetes mellitus (T2DM) patients. In this trial (double-blind, placebo-controlled), 50 T2DM patients (supplement, n = 25 and placebo, n = 25) were randomized and supplemented with 500 mg rutin or placebo per day for 3-months. At the beginning and at the end of the study, metabolic parameters including fasting blood glucose (FBG), insulin, glycosylated hemoglobin (HbA1c), homeostasis model assessment of insulin resistance (HOMO-IR), quantitative insulin sensitivity check index (QUICKI), homeostasis model assessment of ß-cell function (HOMA-ß), triglyceride (TG), total cholesterol (CHOL), high-density and low-density lipoprotein cholesterol (HDL-c and LDL-c), and atherogenic index of plasma (AIP), inflammatory and oxidative stress markers such as interleukin 6 (IL-6), total antioxidant capacity (TAC), and malondialdehyde (MDA) and brain-derived neurotrophic factor (BDNF) were assessed. The results showed a significant decrease in FBG, insulin, HbA1c, HOMO-IR, LDL-c, TG, VLDL, CHOL, LDL-c.HDL-c ratio, AIP, IL-6, and MDA and a significant increase in HDL-c, QUICKI index, BDNF, and TAC compared with the initial value (p for all <.05). In the adjusted model, the mean changes of FBG, insulin, HbA1c, HOMO-IR, LDL-c, CHOL, LDL.HDL ratio, AIP, MDA, and IL-6 were significantly lower and mean changes of QUICKI index, HDL-c, and TAC were significantly higher in the rutin group compared with the placebo group (adjusted p for all <.05). It seems that rutin may have beneficial effects on improving metabolic parameters, BDNF, and inflammatory and oxidative stress factors in T2DM patients.

Effects of melatonin supplementation in patients with type 2 diabetes mellitus and chronic periodontitis under nonsurgical periodontal therapy: A double-blind randomized controlled trial.

Background: The aim of the present study was to investigate the effects of melatonin supplementation along with nonsurgical periodontal therapy (NSPT) in patients with type 2 diabetes mellitus (T2DM) and chronic periodontitis (CP). Materials and Methods: The present study was a double-blind clinical trial. Fifty diabetic patients with periodontitis were randomly allocated to control (n = 25) and intervention groups (n = 25). Two tablets of 250 mg melatonin (6 mg net melatonin) or placebo were received by the intervention or control groups once a day for 8 weeks. Fasting blood glucose (FBG), glycosylated hemoglobin levels (HbA1c), lipid profile, systolic and diastolic blood pressure (SBP and DBP), anthropometric indices including weight, waist and hip circumference (WC and HC), and body mass index (BMI) were measured in patients at the beginning and end of the intervention. Results: Forty-four patients (22 patients in each group) completed the study. In the intervention group, a significant reduction was observed in HbA1c (P = 0.004), weight, BMI, WC, HC (all P < 0.001), DBP (P = 0.017), and SBP (P = 0.006). The high-density lipoprotein-cholesterol was significantly increased in the intervention group after the intervention (P = 0.007). Moreover, after the adjustment of confounding factors, the mean changes of HbA1c (mean difference: -1.30, confidence interval [CI]: -2.41--0.19, P = 0.02), weight (mean difference: -3.90, CI: -5.30-2.50, P < 0.001), WC (mean difference: -1.37, CI: -2.19--0.55, P = 0.002), BMI (mean difference: -1.41, CI: -1.92--0.89, P < 0.001), HC (mean difference: -3.55, CI: -4.74--2.35, P < 0.001), and SBP (mean difference: -1.24, CI: -2.41--0.06, P = 0.03) improved significantly in the intervention group by comparison with the control group. No side effects were reported during the study. Conclusion: The adjunct therapy of NSPT and melatonin may be useful in controlling the glycemic index, lipid profile, BP, and weight in T2DM with CP.

The association of vitamin D, semen parameters, and reproductive hormones with male infertility: A cross-sectional study.

Background: The prevalence of vitamin D deficiency and male infertility is high in Iran. Objective: The present research aimed to examine the association between serum vitamin D [25(OH)D], parameters of semen including semen volume, sperm count, motility and morphology, and reproductive hormones in infertile Iranian men. Materials and Methods: This was a cross-sectional study on 119 infertile men conducted between September 2018 and May 2019. Subjects were divided into 3 groups based on serum vitamin D levels: deficient ( < 10 ng/mL), insufficient (10 ng/mL ≤ 25(OH)D ≤ 30 ng/mL), and sufficient ( > 30 ng/mL). Body mass index and waist circumference were measured. 25(OH)D, testosterone, sex hormone-binding globulin, luteinizing hormone (LH), follicle-stimulating hormone and estradiol levels, and semen parameters were assessed. Results: The semen volume, sperm counts, total and progressively motile sperm, normal sperm morphology, testosterone levels, and testosterone/estradiol ratio were substantially higher in the sufficient group compared to the other groups (p < 0.001). Also, in the sufficient group, serum LH (p < 0.001) and estradiol (p < 0.001, p = 0.01) were notably lower and serum sex hormone-binding globulin (p < 0.001) and the testosterone/LH ratio (p < 0.001) were considerably higher compared to the insufficient and deficient groups. Conclusion: Our study showed a positive relationship between serum vitamin D levels, and seminal parameters and sex hormones in Iranian infertile males.

Vitamin D3 Supplementation Effects on Spermatogram and Oxidative Stress Biomarkers in Asthenozoospermia Infertile Men: a Randomized, Triple-Blind, Placebo-Controlled Clinical Trial.

The objective is to evaluate the effects of vitamin D3 (VD3) on sperm parameters and seminal and serum oxidative stress (OS) biomarkers in asthenozoospermia infertile men. This randomized, triple-masking, placebo-controlled clinical trial conducted on 86 asthenozoospermia infertile men with serum 25 hydroxy vitamin D3 (25-OH-D3) < 30 ng/ml in the infertility clinic of Ahvaz Jahad Daneshgahi, Iran. Patients were randomly allocated to groups A and B, who received daily 4000 IU vitamin D3 (VD3) and matching placebo respectively for 3 months. Demographic data, dietary intake, physical activity, sun exposure, anthropometric indices, serum and seminal levels of MDA (Malondialdehyde), 8-hydroxy-2- Dioxy Guanosine (8-OHDG), total antioxidant capacity (TAC) and calcium, sperm DNA fragmentation index (DFI), serum 25-OH-D3, parathyroid hormone (PTH), phosphorus, and sperm parameters were assessed. VD3 supplementation had no significant effects on body weight, body mass index (BMI), waist circumference (WC), body fat (BF), 8-OHDG, DFI, semen volume, sperm count, and normal sperm morphology, but increased post-intervention mean and mean change of serum 25-OH-D3 (P < 0.001, P < 0.001), PTH (P < 0.001, P < 0.001) and phosphorus (P = 0.009, P = 0.049) and seminal calcium (P = 0.035, P = 0.038) and serum calcium (P = 0.008, P = 0.009), seminal TAC (P < 0.001, P < 0.001), and serum TAC (P = 0.007, P = 005), total sperm motility (P < 0.001, P < 0.001) and progressive sperm motility (P < 0.001, P < 0.001) and decreased seminal MDA (P = 0.017, P = 0.004) and serum MDA (P = 006, P = 0.005) significantly compared to the baseline and placebo group respectively. VD3 supplementation may modulate OS and affect sperm motility in men with asthenozoospermia and serum 25-OH-D3 < 30 ng/ml. Iran Clinical Trials Registry, ID: IRCT20151128025274N4, registered on 28 March 2018, URL of trial registry record: https://www.irct.ir/trial/29983.

Soy Foods and the Risk of Fracture: A Systematic Review of Prospective Cohort Studies.

OBJECTIVES: The primary objective of our study was to systematically review all available prospective cohort studies which investigated the association of soy food intake and incident fracture risk. METHODS: We searched PubMed, Scopus, and Embase databases for relevant studies up to June 2021. SYNTHESIS: Of 695 records, a total of 5 cohort studies were included in the current systematic review. Two studies that were performed in China evaluated hip fracture while 2 studies that were done in Singapore evaluated any kind of fractures. The other study was conducted in Japan and evaluated osteoporosis fractures. All studies used a face-to-face interview to assess the dietary intake of soy foods. All 5 cohort studies were determined to be of high quality. One study considered soy food as a part of a vegetables-fruit-soy food dietary pattern. Others reported the association of dietary intake of soy foods with the risk of fractures. CONCLUSION: The evidence from prospective cohort studies was suggestive for a protective role of soy foods, alone or within a dietary pattern, in the risk of incident fracture among Asian women, particularly for those in early menopause and those who used fermented soy products. But for men, the association was not significant. However, more cohort studies, including non-Asian populations, are required to confirm this association fully.

The effects of Vitamin D3 supplementation on Spermatogram and endocrine factors in asthenozoospermia infertile men: a randomized, triple blind, placebo-controlled clinical trial.

OBJECTIVE: Evaluate the effects of vitamin D3 (VD3) on sperm parameters and endocrine markers in infertile men with asthenozoospermia. MATERIALS AND METHODS: This randomized, triple-masking, placebo-controlled clinical trial conducted on 86 asthenozoospermia infertile men with serum 25 hydroxy vitamin D3 (25(OH)VD3) < 30 ng/ml in the infertility clinic of Ahvaz Jahad daneshgahi, Iran. Patients were randomly allocated to groups A and B, who received daily 4000 IU VD3 and matching placebo respectively for 3 months. Demographic data, dietary intake, physical activity, sun exposure, anthropometric indices, serum 25(OH)VD3, luteinizing hormone (LH), follicle-stimulating hormone (FSH), total testosterone (T), estradiol (E2),, sex hormone-binding globulin (SHBG), free androgen index (FAI = T/SHBG. 100), T/LH and T/E2 ratios, prolactin (PRO), parathyroid hormone (PTH), osteocalcin (OCN), phosphorus and sperm parameters were assessed. RESULTS: Three months VD3 supplementation with 4000 IU/day had no significant effects body weight, body mass index (BMI), waist circumference (WC), body fat (BF), serum, OCN, LH, FSH, T, E2, SHBG, PRO, T/E2 ratio, FAI, semen volume, sperm count and normal sperm morphology. It increases serum 25(OH)VD3, PTH and phosphorus and seminal and serum calcium, T/LH ratio and total and progressive sperm motility and decreased significantly compared to the baseline and placebo group. CONCLUSION: VD3 supplementation may affect sperm motility in men with asthenozoospermia and serum 25(OH)VD3 < 30 ng/ml. TRIAL REGISTRATION: Iran Clinical Trials Registry, ID: IRCT20151128025274N4, registered on 28 March 2018, URL of trial registry record: https://www.irct.ir/trial/29983.

Evaluation of the effect of vitamin D supplementation on spermatogram, seminal and serum levels of oxidative stress indices in asthenospermia infertile men: a study protocol for a triple-blind, randomized controlled trial.

BACKGROUND: It is suggested that vitamin D may have a beneficial role in male reproduction. The male reproductive system is a target tissue for vitamin D. This study will aim to evaluate the effects of vitamin D supplementation on sperm parameters, seminal and serum levels of oxidative stress and serum endocrine factors in asthenospermia infertile men. METHODS/DESIGN: This randomized, triple-blind, placebo-controlled clinical trial will be conducted on 86 infertile men with idiopathic asthenozoospermia (the mobility of sperm < 40% and rapid progressive sperm motility < 32%), with serum levels of vitamin D less than 30 ng / ml in the "Infertility Clinic of Ahvaz Jahad daneshgahi", Iran. MAIN OUTCOMES MEASURE (S): Demographic data, dietary intake, physical activity, sun exposure, anthropometric indices, serum and seminal levels of MDA (Malondialdehyde), 8-hydroxy-2- Dioxy Guanosine (8-OHDG), Total Antioxidant Capacity (TAC) and calcium, sperm DNA fragmentation index (DFI), serum 25-OHD, luteinizing hormone (LH), follicle-stimulating hormone (FSH), total testosterone (T), estradiol (E2), sex hormone-binding globulin (SHBG), free androgen index (FAI = T/SHBG. 100), T/LH and T/E2 ratios, prolactin (PRO), parathyroid hormone (PTH), osteocalcin (OCN), phosphorus and sperm parameters. DISCUSSION: The deficiency of vitamin D as an antioxidant is common all over the world. Numerous observational studies have shown a positive association between vitamin D levels and semen quality. However, few clinical studies have been conducted in this area. So considering with the high prevalence of this antioxidant deficiency specifically in infertile men, it seems that the supplementation of vitamin D in infertile men with insufficient levels or deficiency may improve the status of oxidative stress and thereby may affect sperm parameters and endocrine factors involved in male fertility. TRIAL REGISTRATION: Iran Clinical Trials Registry, ID: IRCT20151128025274N4 , registered on 28 March 2018.

Consumption of melatonin supplement improves cardiovascular disease risk factors and anthropometric indices in type 2 diabetes mellitus patients: a double-blind, randomized, placebo-controlled trial.

BACKGROUND: Diabetes mellitus is a common chronic disease. Dyslipidemia and hypertension are two complications that may develop in diabetic patients if hyperglycemia, insulin resistance, and weight gain are not controlled. This study investigated the effects of melatonin supplementation on some cardiovascular disease risk factors and anthropometric indices in patients with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: In this double-blind, randomized, placebo-controlled trial, 50 T2DM patients were randomly allocated to intervention and control groups which received two tablets of either melatonin or placebo (250 mg) once a day for 8 weeks. Systolic blood pressure (SBP), mean arterial pressure (MAP), pulse pressure (PP), the atherogenic index of plasma (AIP), weight, body mass index (BMI), waist and hip circumference (WC, HC), a body shape index (ABSI), abdominal volume index (AVI), body adiposity index (BAI), lipid accumulation product (LAP), conicity index, and waist-to-height ratio (WHtR) were evaluated in all the patients pre- and post-intervention. RESULTS: Melatonin supplementation for 8 weeks significantly decreased the mean levels of SBP, MAP, PP, weight, BMI, WC, HC, BAI, AVI, conicity index, and WHtR post-intervention (p <  0.05). Also, the median changes of SBP, MAP, PP, weight, BMI, WC, HC BAI, AVI, and conicity index were significantly lower in the intervention group compared with the control group (p <  0.05). A significant increase (p <  0.001) was observed in the mean levels of ABSI in the intervention group. The median changes of ABSI were significantly greater in the intervention group compared with the control group (p <  0.001). CONCLUSIONS: Consumption of melatonin supplement may be effective in controlling arterial pressure including SBP, MAP, and PP and anthropometric indices (as predictors of obesity) in T2DM patients. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20190303042905N1 . Registered on 17 May 2019.

The association between dietary inflammatory index with sleep quality and obesity amongst iranian female students: A cross-sectional study.

BACKGROUND: Overweight, obesity and lack of sleep quality as inflammatory states are the common problems amongst college students and the Association of Dietary Inflammatory Index (DII) with these problems amongst this population is unknown. We aimed to evaluate the relationship of the DII with obesity and sleep quality amongst Iranian female students. METHODS: The present cross-sectional study was conducted on 249 female college students. The Dietary Inflammatory Index (DII) was calculated using a valid and reliable 147-item food frequency questionnaire (FFQ). To assess sleep quality, Pittsburgh Sleep Quality Index (PSQI) was used. Odds Ratio (OR) and 95% Confidence Intervals (CIs) were estimated for anthropometric indices and sleep quality according to the DII score. Linear regression was used to estimate the relationship between DII score with sleep and anthropometric indices. RESULTS: There was a significant association evident between DII and sleep quality (>5 is considered as poor quality of sleep); ie, the odds ratios between DII quartile 2 vs 1 (unadjusted model: OR = 0.33 (CI: 0.14-0.74), P for trend = .002; model 1: the fully adjusted OR = 0.31(CI: 0.12-0.78), P for trend = .005; model 2:OR = 0.30 (CI: 0.12-0.78), P for trend = .005) to quartile 4(unadjusted model: OR = 1.13(CI: 0.45-2.80); model 1: OR = 1.11(CI: 0.44-2.79); model 2:OR = 1.13(CI: 0.44-2.87), P for trend = .005). Also, odds ratios increased significantly from quartile 2 to quartile 4 in all models for DII and sleep quality. According to the continuous score of DII, there was a significant positive association between DII and sleep quality in all three models: unadjusted, model 1, and model 2 (OR = 1.21 (CI: 1.05-1.40), OR = 1.21 (CI: 1.03-1.43), and OR = 1.22 (CI: 1.03-1.44), respectively. CONCLUSIONS: In this study, after removing the effect of confounding factors, participants in the highest quartile of DII score had significantly higher PSQI global score.

Effect of Fasting-Mimicking Diet or Continuous Energy Restriction on Weight Loss, Body Composition, and Appetite-Regulating Hormones Among Metabolically Healthy Women with Obesity: a Randomized Controlled, Parallel Trial.

BACKGROUND: Fasting-mimicking diet (FMD) has been recently promoted to achieve similar metabolic changes of fasting. The purpose of our study was to compare the effect of FMD versus continuous energy restriction (CER) on anthropometric measurements, body composition, glucose metabolism, and serum levels of leptin, neuropeptide Y (NPY), and total ghrelin. METHODS: A randomized controlled trial (RCT) was conducted on 60 women with obesity aged 18-55 years. Subjects received either a 5-day FMD (low in energy, sugars, and proteins, but high in unsaturated fats) or a CER (an average daily energy deficit of 500 kcal) for 2 months. Anthropometric and biochemical factors were measured at baseline and the end of the study. Serum levels of leptin, total ghrelin, and NPY were tested with an ELISA kit. Physical activity and dietary intakes were also recorded. RESULTS: There was no significant difference in weight loss between the two groups: mean weight change for CER was - 2.29 (standard deviation [SD], 1.95) kg compared to - 1.13 (2.27) kg for FMD (p = 0.06). There was more reduction in the basal metabolic rate (BMR) in the CER group (p = 0.045). Favorable effects on fat mass and muscle mass were only seen in the FMD group. Although insulin resistance was reduced in the FMD group compared to the CER group, results were not significant after adjustment. After controlling for potential confounders, there was a significant increase in serum levels of total ghrelin (p = 0.048) and NPY (p = 0.041) following CER; however, results for circulating leptin were not statistically significant (p = 0.48). CONCLUSIONS: There was no significant difference in weight loss following FMD and CER. However, FMD was more effective at reducing insulin resistance and regulating appetite-regulating hormones as well as preserving muscle mass and BMR. TRIAL REGISTRATION: This trial was registered at the Iranian Clinical Trial Registry ( https://www.irct.ir/trial/40881 ) with the IRCT identification number IRCT20190717044244N1.

Ginseng and Cancer-Related Fatigue: A Systematic Review of Clinical Trials.

PURPOSE: The data on the effect of ginseng on general fatigue were previously reviewed. However, there is limited data on the effect of various types of ginseng on cancer-related fatigue (CRF). CRF is one of the most pervasive symptoms of cancer and cancer treatment. The primary objective of the current study was to systematically review trials investigating the safety and efficacy of three different types of ginseng separately used in the treatment protocol for patients with CRF. METHODS: We searched the available online databases for relevant publications up to October 2019. Data were independently extracted by two reviewers. We assessed the risk of bias using the Cochrane Collaboration Review Manager (RevMan, version 5.3) and reported the results in a narrative summary. RESULTS: A total of 210 studies were identified by the initial search, from which seven clinical trials and one retrospective study were included in this systematic review. A total of two clinical trials and one retrospective review examined the impact of American ginseng on CRF symptoms, three studies tested Asian ginseng, and two trials were conducted using Korean ginseng. The quality of the selected studies varied greatly. All three types of ginseng were tolerated well with few low-grade adverse events. American ginseng, containing more than 5% ginsenosides, consumed at the dosage of 2000 mg/day for up to eight weeks significantly reduced fatigue. Asian ginseng, containing ≥ 7% ginsenosides, relieved symptoms of fatigue at the dosage of 400 mg/day in the majority of patients with CRF. Korean ginseng, consumed at the dosage of 3000 mg/day for 12 weeks, decreased symptoms of CRF. CONCLUSIONS: Although our findings support the safety and effectiveness of ginseng in the treatment of CRF, the number of high-quality studies is not adequate to adopt ginseng as a standard treatment option for CRF.

Lycopene Does Not Affect Prostate-Specific Antigen in Men with Non-Metastatic Prostate Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Several randomized controlled trials (RCTs) have investigated the effect of lycopene supplementation on serum levels of prostate-specific antigen (PSA) in patients with prostate cancer. However, results have been inconclusive. We systematically searched PubMed, Embase, and Scopus up to January 2020 to find RCTs investigating the effect of lycopene supplementation on serum levels of PSA in patients with non-metastatic prostate cancer. Using a random-effects model, the reported risk estimates were pooled. A total of six trials were included in the final analysis. we found no significant effect of lycopene on circulating PSA (WMD: -0.60, 95% CI: -2.01, 0.81 µg/L). However, we observed a significant reducing effect when the analysis was confined to studies that included patients with higher baseline levels of PSA (≥6.5 µg/L) (WMD: -3.74 µg/L, 95% CI: -5.15, -2.32, P < 0.001). Subgroup analysis based on the duration of intervention did not result in any significant effect. Non-linear dose-response analysis did not show any significant effects of lycopene dosage (Pnon-linearity = 0.50) and duration of the intervention (Pnon-linearity = 0.63) on serum levels of PSA. Although lycopene supplementation did not produce any reduction in PSA levels overall, a significant reducing effect was observed in patients with higher levels of baseline PSA. Due to the heterogeneity of our results, further high-quality clinical trials with long-term duration are required to determine the efficacy of lycopene in patients with non-metastatic prostate cancer.

Effects of Concurrent Omega-3 and Cranberry Juice Consumption Along with Standard Antibiotic Therapy on the Eradication of Helicobacter pylori, Gastrointestinal Symptoms, Some Serum Inflammatory and Oxidative Stress Markers in Adults with Helicobacter pylori Infection: A Study Protocol for a Randomized Controlled Trial.

BACKGROUND: It seems alternative treatments such as antioxidant intervention and anti-inflammatory intervention adjuvant to antibiotic regimens may enhance cancer prevention approaches and decrease adverse side effects related to therapeutic antibiotic regimens. So, we will evaluate the effects of concurrent omega-3 and cranberry juice supplementation along with standard antibiotic therapy on the eradication of Helicobacter pylori, gastrointestinal symptoms, some serum inflammatory and oxidative stress markers in adults with HP infection. METHODS: We will conduct a 4-week double-blinded randomized clinical trial. The subjects will be randomly stratified according to sex and BMI using a permuted block randomization procedure by Random Allocation Software (RAS). They will be assigned to one of the four study groups: (1) cranberry juice fortified with omega-3 Intervention (n=23), (2) cranberry juice intervention group (n=23), (3) placebo beverage fortified with omega-3 intervention group (n=23), and (4) placebo beverage intervention (control group) (n=23). All statistical analyses will be performed using IBM SPSS Statistics software. DISCUSSION: A combination of alternative therapies may have a synergistic effect compared to a single approach. It could potentially be more effective in promoting the efficacy of standard antibiotic therapy in eradicating HP infection. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT20151128025274N3, www.irct.ir/trial/28997). TRIAL STATUS: This study is in the early stages of sampling.

The Impact of Obesity on Various Semen Parameters and Sex Hormones in Iranian Men with Infertility: A Cross-Sectional Study.

OBJECTIVE: The aim of this study was to examine the correlations between body mass index (BMI) and waist circumference (WC) and semen parameters (semen volume, sperm count, motility, and morphology) and sex hormones in Iranian men with infertility. MATERIALS AND METHODS: In this cross-sectional study, a total of 119 male patients who had lived as a partner in an infertile couple for at least 1 year, after regular unprotected sexual intercourse in their married life were investigated. BMI and WC were assessed, and a morning blood sample was taken assessing serum levels of testosterone (T), sex hormone-binding globulin (SHBG), prolactin (PRL), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2) and leptin. Semen-analysis parameters were also measured. RESULTS: Based on BMI and WC, the sperm count, total motility and progressive sperm were significantly lower in overweight and obese infertile males compared to that in normal weight infertile males and those with WC<102 cm. In addition, the fraction of sperm with abnormal morphology was significantly higher in infertile men with WC>102 cm compared to that in those with WC<102 cm. Moreover serum levels of LH, FSH, and leptin were significantly higher in overweight and obese infertile males compared to that in normal weight infertile males and those with WC<102 cm. Moreover serum level of E2 was significantly higher in obese infertile males compared to the normal weight infertile males and in those with WC>102 cm compared to the WC<102 cm. Furthermore, serum level of T was significantly lower in obese infertile males compared to the overweight infertile males and in those with WC>102 cm compared to the WC<102 cm. The mean of T/E2 ratio also was significantly lower in obese infertile males vs overweight and normal weight infertile males and in those with WC>102 cm compared to the WC<102 cm. CONCLUSION: We concluded that overweight and obesity in infertile men compared to those with normal weight may worsen the infertility situation.

Major dietary patterns in relation to obesity and quality of sleep among female university students.

BACKGROUND: Few studies reported the association of dietary patterns with obesity, central adiposity, and quality of sleep. We aimed to investigate the association between major dietary patterns and anthropometric indices in relation to obesity and quality of sleep among female students of Ahvaz Jundishapur University of Medical Sciences (AJUMS). METHODS: This cross-sectional study was conducted on 245 female university students aged 18-38 years. To assess sleep quality, we used a self-reported Pittsburgh sleep quality index (PSQI). Usual dietary intakes were assessed with the use of a 168 items food frequency questionnaire (FFQ). We used factor analysis to identify dietary patterns. RESULTS: Four major dietary patterns were identified: mixed, high protein, Western, and healthy dietary patterns. After adjustment for energy intake, subjects in the upper tertile of the mixed dietary pattern were more likely to have a high quality of sleep than those in the first tertile (odds ratio [OR]: 0.27; 95% CI: 0.13, 0.55). Individuals with greater adherence to Western dietary pattern had greater odds of having low quality of sleep compared to those in the first tertile (OR: 1.99; 95% CI: 1.04, 3.82). A healthy dietary pattern was associated with a higher quality of sleep; however, the association was no longer significant after adjustment for dietary energy intake. No significant association was found for high protein dietary patterns. Compared to the first tertile of the healthy dietary pattern, individuals in the upper tertile were less likely to be centrally obese (OR = 0.15; 95% CI = 0.50-0.52). Participants in the last tertile of the high protein dietary pattern were less likely to be generally obese (OR = 0.34; 95% CI = 0.12-0.99), whereas those in the upper tertile of the Western dietary pattern were more likely to be generally obese (OR = 1.84; 95% CI = 1.08-4.93). CONCLUSIONS: Adherence to a mixed dietary pattern was associated with a high quality of sleep; however, the result was not significant for a high protein dietary pattern. While the high protein dietary pattern was negatively associated with general and central obesity, students in the upper tertile of the Western dietary pattern were more likely to be generally obese.

Heavy metals risk assessment in fish species (Johnius Belangerii (C) and Cynoglossus Arel) in Musa Estuary, Persian Gulf.

In this study the possible health effects of consumption of benthopelagic (Johnius Belangerii (C); JB) and demersal (Cynoglossus Arel; CA) fishes were evaluated. These fish species living in the Musa estuary (the biggest estuary in the south of Iran and in the northern coastline of Persian Gulf) are likely to be polluted with Hg, V, Ni and Tl. The food frequency questionnaire (FFQ) was used to estimate fish intakes in the residents of Mahshahr city. Also, heavy metal concentrations were determined in fishes and compared with the maximum permissible levels (MPLs). The bioaccumulation factor (BAF) showed high bioaccumulation ability for Hg and Tl in both fish spices. The ratio of TDI/EDI showed the importance of the health hazard by both fish consumption. Also, Hg and Tl in fishes had a higher calculated target hazard quotient (THQ) than the limits. Regarding with the high possibility of serious health concerns associated with Hg and Tl contamination in the Musa estuary, it is suggested to do appropriate and urgent actions by the governors.