Protective Effect of Vitamin D Supplementation on Some Hemogram Derived Inflammatory Indices in Normal and High-Fat Diet Fed Male Wistar Rats.

Background: Hematological inflammatory indices are currently suggested to assess systemic inflammation. This study aims to investigate a vitamin D supplementation effect on hematological indices of inflammation in rats. Method: Forty-eight middle-aged male rats were allocated into a normal diet (ND) group (10% fat) and a high-fat diet (HFD) group (60% fat). The animals were fed for 26 weeks. After this period, each group was randomly divided into three subgroups, each of 8 rats: Group (1): animals were fed the ND and HFD containing 1 IU/g vitamin D for 4 months, group (2): animals were fed the ND and HFD containing 6 IU/g vitamin D for 4 months and group (3): animals were euthanized to evaluate the HFD effect. Serum 25-hydroxyvitamin D level, white blood cell count (WBCs), platelet count, platelet crit (PCT), mean platelet volume (MPV), platelet distribution width (PDW), platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR) were measured. Results: The HFD, significantly increased body weight, PCT, PDW, PLR, NLR, and MLR and significantly reduced serum vitamin D levels compared to the ND (P < 0.05). There was a significant decrease in food intake, MPV, PDW, and NLR after vitamin D supplementation in the ND-fed group (P < 0.05). A significant reduction in platelet count, PCT, and MLR was observed after vitamin D supplementation in HFD-fed rats (P < 0.05). Conclusions: In our study, some hemogram-derived inflammatory indices were higher in the HFD-fed group, and vitamin D supplementation lowering effects on some hematological indices were seen in both ND and HFD groups.

Effect of sumac powder on clinical symptoms, hyperandrogenism, inflammation, blood glucose, lipid profiles in women with polycystic ovary syndrome: A double-blind randomized clinical trial.

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders associated with a high risk of diabetes, atherosclerosis, and cardiovascular disease. The purpose of this study was to determine the effect of sumac powder on clinical symptoms and laboratory parameters in women with PCOS. The double-blind randomized controlled clinical trial was conducted on 88 women with PCOS randomly assigned to the intervention and control groups. The intervention group received three capsules each containing 1 g of sumac powder for 12 weeks. All data and serum levels of sex hormone, hs-CRP, glucose, and lipid profiles were measured at the baseline and at the end of the study. Data were analyzed using SPSS version 25 software. The ANCOVA test results showed that hs-CRP level was significantly reduced in the intervention group (p = .008). Blood glucose and lipid profiles in the intervention group were significantly reduced compared to the placebo group (p < .05). Insulin sensitivity and HDL levels were increased significantly in the Sumac group after the intervention (p < .05). Sumac powder can reduce the inflammatory effects, and glycemic status and lipid profile of polycystic ovaries in affected women, but has no significant effect on anthropometric parameters and sex hormones.

Information System Success of the Iranian Integrated Health Record System Based on the Clinical Information System Success Model.

Background: The Integrated Health Record System, locally known as the "SIB," is the most used information system for recording public health services provided to the Iranian population. The objective of this study was to evaluate the success rate of the SIB using the Clinical Information System Success Model (CISSM). Methods: This is a psychometric and evaluation study. The CISSM has a 26-item instrument that assesses 7 constructs in 3 following stages: (1) the socio-technical stage (facilitating conditions, social influence, information quality, and system performance(; (2) the integrated stage (system use dependency and user satisfaction); and (3) success outcome stage (net benefit). A Persian version of the CISSM instrument was validated and applied in this study. Based on this instrument, the reliability and the validity of the CISSM were assessed. The SIB success rate was evaluated using a validated CISSM. The study participants were 758 SIB users from different disciplines and different levels. Results: Assessment of content validity, construct validity, internal consistency, and test-retest reliability showed acceptable psychometric properties of the CISSM instrument. The results demonstrated that the SIB success rate was in the moderate range (59.6%). Facilitating conditions and information quality were strong predictors of use dependency and user satisfaction, while both of these 2 constructs significantly influenced net benefit. Conclusion: The SIB success was in the moderate range, and it needs to be enhanced. Therefore, Iranian healthcare policymakers should consider working on the most important factors influencing SIB success (facilitating conditions, information quality, use dependency, and user satisfaction) to improve SIB success.

Development of an Instrument to Measure Dietary Supplement Health Literacy.

BACKGROUND: Health literacy is one of the important social determinants of health. OBJECTIVE: The aim of this study was to develop an instrument to measure Dietary Supplement Health Literacy (DSHL) of Iranian women. METHODS: In this psychometrics study, an initial nine-factor instrument was developed. Face validity and content validity of the instrument were evaluated. The factor structure of the instrument was explored by the Exploratory Factor Analysis (EFA) among 400 women taking Dietary supplement. Confirmatory Factor Analysis (CFA) was done to determine the underlying factor structure of the instrument in this population. The internal and external reliability of the instrument was evaluated. KEY RESULTS: According to expert panel opinions, 16 items were deleted. The results of the EFA showed that the Kaiser-Meyer-Olkin and Bartlett's test of sphericity were significant. EFA showed that 30 items could be grouped into nine factors that accounted for 60.84% of the variance. Since two items in the ability to actively engage with health care providers factor were loaded in factor 1, this factor was labeled Engaging in receiving informational supports from health care providers. In addition, one item of the dimension was loaded in factor 3. Given that the one item of factor 5 and 1 item of factor 6 were loaded in a new factor 9, this factor was labeled Applying information to decision-making. The CFA indicated that the nine-factor structure of the DSHL instrument had a poor fit. To modify indices, factor 9 with 2 items and 1 item of factor 6 were deleted. The Cronbach's alpha and intraclass correlation coefficient of the instrument were acceptable. Finally, a 27-item instrument with 8 dimensions was confirmed. CONCLUSIONS: The results of the study showed that the instrument developed was a valid tool for identifying the DSHL of Iranian women. [HLRP: Health Literacy Research and Practice. 2022;6(2):e159-e166.] Plain Language Summary: This study sought to develop and validate a multidimensional instrument to measure the health literacy of Iranian women about dietary supplements that was performed from July 2019 to May 2020 in Iran. Findings showed that the 30-item instrument developed in this study is a valid instrument to be used for identifying the health literacy of Iranian women about dietary supplements.

Effects of supplementation of vitamins D, C and E on Idiopathic Pulmonary Fibrosis (IPF): A clinical trial.

BACKGROUND & AIMS: Idiopathic pulmonary fibrosis (IPF) is a chronic disease with a growing prevalence. We aimed to evaluate the effects of co-supplementation with vitamins C, E, and D on respiratory, inflammatory, and oxidative stress outcomes in IPF patients. METHODS: Thirty-three patients participated in this quasi-experimental study and were supplemented with vitamins E, C, and D with 200 IU/daily, 250 mg/every other day and 50000 IU/Weekly, respectively for 12 weeks. Anthropometric indices, dietary recall, physical activity, Saint George questionnaire were assessed along with the biochemical measures of inflammation and oxidative stress, and respiratory parameters. Data were analyzed by SPSS version 21, and P-value ≤ 0.05 was considered significant. RESULTS: Results of spirometry and plethysmography tests showed a significant increase in FEV1 (P-value = 0.016), IRV (P-value = 0.001), RV (P-value = 0.002) and TLC (P-value = 0.003). But no significant change was observed in FVC, VC, FEV1/FVC, and ERV. We also found that ESR, hs-CRP, TGFß, and PrC remarkably reduced after the supplementation (P-value ≤ 0.05), while the GPx level remained unchanged. CONCLUSIONS: It is concluded that three months of supplementation with a combination of D, C, and E vitamins in IPF patients may positively affect the respiratory function and alleviate the inflammation and oxidative stress.

Investigation on factors associated with ovarian cancer: an umbrella review of systematic review and meta-analyses.

Following cervical and uterine cancer, ovarian cancer (OC) has the third rank in gynecologic cancers. It often remains non-diagnosed until it spreads throughout the pelvis and abdomen. Identification of the most effective risk factors can help take prevention measures concerning OC. Therefore, the presented review aims to summarize the available studies on OC risk factors. A comprehensive systematic literature search was performed to identify all published systematic reviews and meta-analysis on associated factors with ovarian cancer. Web of Science, Cochrane Library databases, and Google Scholar were searched up to 17th January 2020. This study was performed according to Smith et al. methodology for conducting a systematic review of systematic reviews. Twenty-eight thousand sixty-two papers were initially retrieved from the electronic databases, among which 20,104 studies were screened. Two hundred seventy-seven articles met our inclusion criteria, 226 of which included in the meta-analysis. Most commonly reported genetic factors were MTHFR C677T (OR=1.077; 95 % CI (1.032, 1.124); P-value<0.001), BSML rs1544410 (OR=1.078; 95 %CI (1.024, 1.153); P-value=0.004), and Fokl rs2228570 (OR=1.123; 95 % CI (1.089, 1.157); P-value<0.001), which were significantly associated with increasing risk of ovarian cancer. Among the other factors, coffee intake (OR=1.106; 95 % CI (1.009, 1.211); P-value=0.030), hormone therapy (RR=1.057; 95 % CI (1.030, 1.400); P-value<0.001), hysterectomy (OR=0.863; 95 % CI (0.745, 0.999); P-value=0.049), and breast feeding (OR=0.719, 95 % CI (0.679, 0.762) and P-value<0.001) were mostly reported in studies. Among nutritional factors, coffee, egg, and fat intake significantly increase the risk of ovarian cancer. Estrogen, estrogen-progesterone, and overall hormone therapies also are related to the higher incidence of ovarian cancer. Some diseases, such as diabetes, endometriosis, and polycystic ovarian syndrome, as well as several genetic polymorphisms, cause a significant increase in ovarian cancer occurrence. Moreover, other factors, for instance, obesity, overweight, smoking, and perineal talc use, significantly increase the risk of ovarian cancer.

Effect of Portulaca Oleracea (purslane) extract on liver enzymes, lipid profile, and glycemic status in nonalcoholic fatty liver disease: A randomized, double-blind clinical trial.

Purslane (Portulaca oleracea L.) is the richest green leafy vegetable source of omega-3, especially alpha linolenic acid (ALA). Experimental studies have shown beneficial effects of purslane extract on liver enzymes. The aim of the present study was to examine the effect of purslane hydroalcohoic extract in patients with non-alcoholic fatty liver disease (NAFLD). In a randomized double-blinded clinical trial, 74 patients were randomly assigned to receive either 300 mg purslane extract or placebo capsules for 12 weeks. Compared with baseline, alanine aminotransferase (ALT) (-9 [-17, 0.50] mg/dl; p = .007), aspartate aminotransferase (AST) (-4 [-10, -0.50] mg/dl; p = .001), gamma glutamyltransferase (GGT) (-6.21 ± 9.85 mg/dL; p < .001), fasting blood glucose (FBG) (-8 [-11, -1.50] mg/dl; p < .001) insulin resistance (-0.95 ± 2.23; p = .020), triglyceride (-20 [-67.50, 3.50] mg/dl; p = .010), and low-density lipoprotein cholesterol (LDL-C) (-5 [-12, -1] mg/dl; p < .001) decreased significantly in the purslane group. At the end of study, no significant changes were observed in liver steatosis grade, insulin, liver enzymes, total bilirubin, lipid profile, and blood pressure between the two groups. The findings of our study show that purslane extract at the dose of 300 mg/day for 12 weeks has no significant effects on liver enzymes, lipid profile, and glycemic indices in patients with NAFLD.

The effects of Chlorella supplementation on glycemic control, lipid profile and anthropometric measures on patients with type 2 diabetes mellitus.

BACKGROUND: Diabetes is a chronic disease and the prevalence of it is rapidly increasing. Recently, the use of natural products in chronic diseases such as diabetes has gained more attention. Chlorella, a single-celled green alga, is one of them. There have been some studies on the effects of chlorella supplementation in chronic diseases such as NAFLD, prediabetes, and diabetic mice, but none of them examined the effects of chlorella in patients with T2DM. The present study was designed to evaluate the effects of chlorella supplementation on glycemic control, lipid profile, and anthropometric indices in type 2 diabetic patients. METHODS: This study is a double-blind, randomized controlled trial. 84 patients with T2DM assigned into two groups, receiving 1500 mg/day C. vulgaris or placebo for 8 weeks. Anthropometric information, blood pressure, 24-h food intake recall, and blood samples were collected at the beginning and end of the study to determine the changes of FBS, HbA1c, insulin concentration, insulin resistance, and lipid profile. RESULTS: None of the variables investigated in this study showed a significant change after 8 weeks of intervention with C. vulgaris. CONCLUSION: According to the findings of this study, supplementation with C. vulgaris with a dosage of 1500 mg/day for 8 weeks, does not improve the anthropometric measurements, glycemic status, and lipid profile as well. Thus, it cannot be considered as a complementary therapeutic approach to common medications at this dosage and duration. However, future studies with a higher dosage of C. vulgaris and more prolonged than 8 weeks are needed to be done.

A randomized controlled trial on the coloprotective effect of coenzyme Q10 on immune-inflammatory cytokines, oxidative status, antimicrobial peptides, and microRNA-146a expression in patients with mild-to-moderate ulcerative colitis.

PURPOSE: Coenzyme Q10 (CoQ10), having potent antioxidant and anti-inflammatory pharmacological properties, has recently been shown to be a safe and promising agent in maintaining remission of ulcerative colitis (UC). This trial was, therefore, designed to determine CoQ10 efficacy on inflammation and antioxidant status, antimicrobial peptides, and microRNA-146a expression in UC patients. METHODS: In this randomized double-blind controlled trial, 88 mild-to-moderate UC patients were randomly allocated to receive CoQ10 (200 mg/day) or placebo (rice flour) for 2 months. At the baseline and at an 8-week follow-up, serum levels of Nrf2, cathelicidin LL-37, ß-defensin 2, IL-10, IL-17, NF-κB p65 activity in peripheral blood mononuclear cells (PBMCs), simple clinical colitis activity index questionnaire (SCCAIQ), and quality of life (IBDQ-32 score), as well as an expression rate of microRNA-146a were measured. RESULTS: A significant reduction was detected in the serum IL-17 level, activity of NF-κB p65 in PBMCs, and also SCCAI score in the CoQ10 group compared to the placebo group, whereas IL-10 serum concentrations and IBDQ-32 score of the CoQ10 group considerably increased versus the control group; the changes of these variables were also significantly different within and between groups at the end of the study. Furthermore, CoQ10 remarkably increased serum levels of cathelicidin LL-37. A significant change in serum cathelicidin LL-37 levels was also observed between the two groups. No statistical difference, however, was seen between the two groups in terms of the serum levels of Nrf2 and ß-defensin 2 and the relative expression of microRNA-146a. CONCLUSIONS: Our results indicate that CoQ10 supplementation, along with drug therapy, appears to be an efficient reducer of inflammation in patients with mild-to-moderate UC at a remission phase. TRIAL REGISTRATION: The research has also been registered at the Iranian Registry of Clinical Trials (IRCT): IRCT20090822002365N17.

Randomized Study of the Effects of Zinc, Vitamin A, and Magnesium Co-supplementation on Thyroid Function, Oxidative Stress, and hs-CRP in Patients with Hypothyroidism.

Hypothyroidism can occur due to deficiencies in micronutrients such as zinc, magnesium, and vitamin A. The aim of this study was to determine the effects of supplementation with these micronutrients on thyroid function, oxidative stress, and hs-CRP levels in patients with hypothyroidism. In a randomized double-blind, placebo-controlled trial with two parallel groups, 86 hypothyroid patients aged 20-65 were allocated to receive daily supplementation with either: (intervention group, n = 43) one 30 mg zinc gluconate capsule per day, one 250 mg magnesium oxide tablet per day, and one 25,000 IU vitamin A capsule twice/week for 10 weeks or (placebo group, n = 43) placebo capsules and tablets as above for 10 weeks. Neither of the groups changed their diet or physical activity. Thyroid hormones (free and total thyroxine (FT4 and TT4), free tri-iodothyronine (FT3), and thyroid-stimulating hormone (TSH)), oxidative markers (malondialdehyde (MDA) and total antioxidant capacity (TAC)), serum hs-CRP, and anthropometric indices (height and weight) were assessed at the baseline and at the end of the study. In the intervention group, we found a significant increase in serum FT4, decreased anthropometric indices, and lower levels of serum hs-CRP by the end of the 10 week protocol (P < 0.05). In the placebo group, serum TAC was decreased and hs-CRP increased (P < 0.05), with no significant changes in serum TSH, FT3, TT4, and MDA after the intervention. Zinc, vitamin A, and magnesium supplementation may have beneficial effects in patients with hypothyroidism and in diseases associated with hyperthyroidism.

The effect of synbiotic on glycemic profile and sex hormones in overweight and obese breast cancer survivors following a weight-loss diet: A randomized, triple-blind, controlled trial.

BACKGROUND: The investigation was designed to assess the effects of synbiotic supplementation on glycemic profile, insulin-like growth factor-1 (IGF-1) and sex hormones in overweight and obese postmenopausal breast cancer survivors (BCSs) who had hormone-receptor-positive breast cancer. METHODS: This randomized, triple-blind, placebo-controlled trial was conducted on 76 overweight and obese BCSs aged 57.43 (5.82) years. All participants were given a specified low calorie diet and were randomly assigned into two groups to intake 109 CFU/day of synbiotic supplement (n = 38) or placebo (n = 38) for 8 weeks. Body composition, physical activity, glycemic profile, IGF-1, estradiol, testosterone and dehydroepiandrosterone sulfate (DHEA-S) were measured at baseline and after 8 weeks. RESULTS: A significant reduction in serum insulin (median change (Q1, Q3) from baseline of -1.05 (-2.36, 0.32) µIU/mL; P = 0.006) and insulin resistance (HOMA-IR) (mean change (SD) from baseline of -4.0 (0.9); P = 0.007) were seen over the 8 weeks in the synbiotic group. However, no significant changes were observed in serum insulin, fasting plasma glucose, HbA1c, HOMA-IR, IGF-1, estradiol, testosterone, DHEA-S and sex hormone binding globulin between-groups at the end of the intervention. CONCLUSIONS: Overall, as the 8-week synbiotic consumption compared with placebo had insignificant-reducing effects on glycemic profile, IGF-1 and sex hormones among overweight and obese postmenopausal BCSs, synbiotics may exert considerable beneficial consequences, which need to be further assessed in future clinical trials. TRIAL REGISTRATION: IRCT, IRCT2015090223861N1. Registered 02 February 2017, http://www.irct.ir: IRCT2015090223861N1.

Effects of quercetin supplementation on inflammatory factors and quality of life in post-myocardial infarction patients: A double blind, placebo-controlled, randomized clinical trial.

Myocardial infarction (MI) is one of the leading causes of death in the world. Epidemiological studies have shown that dietary flavonoids are inversely related to cardiovascular morbidity and mortality. The study aimed to determine whether quercetin supplementation can improve inflammatory factors, total antioxidant capacity (TAC) and quality of life (QOL) in patients following MI. This randomized double-blind, placebo-controlled trial was conducted on 88 post-MI patients. Participants were randomly assigned into quercetin (n = 44) and placebo groups (n = 44) receiving 500 mg/day quercetin or placebo tablets for 8 weeks. Quercetin supplementation significantly increased serum TAC compared to placebo (Difference: 0.24 (0.01) mmol/L and 0.00 (0.00) mmol/L respectively; p < .001). TNF-α levels significantly decreased in the quercetin group (p = .009); this was not, however, significant compared to the placebo group. As for QOL dimensions, quercetin significantly lowered the scores of insecurity (Difference: -0.66 (12.5) and 0.00 (5.55) respectively; p < .001). No significant changes in IL-6, hs-CRP, blood pressure and other QOL dimensions were observed between the two groups. Quercetin supplementation (500 mg/day) in post-MI patients for 8 weeks significantly elevated TAC and improved the insecurity dimension of QOL, but failed to show any significant effect on inflammatory factors, blood pressure and other QOL dimensions.

The effects of sumac (Rhus coriaria L.) powder supplementation in patients with non-alcoholic fatty liver disease: A randomized controlled trial.

BACKGROUND: In recent years, great attention has been paid to the role of herbal medicine in the management of non-alcoholic fatty liver disease (NAFLD). Sumac (Rhus coriaria L.) is a popular herb which contains major bioactive compounds known for a variety of health benefits. This study aimed to assess the effects of sumac powder supplementation on hepatic fibrosis and some metabolic markers in patients with NAFLD. METHODS: Eighty-four patients diagnosed with NAFLD were included in this randomized double-blind placebo-controlled clinical trial. They were randomly assigned to receive 2000 mg per day sumac powder (n = 42) or placebo (n = 42) for 12 weeks. Also, both groups received a 500-calories deficit diet plan. Hepatic fibrosis and liver enzymes (ALT and AST) as well as fasting blood sugar (FBS), serum insulin, HbA1c, HOMA-IR (insulin resistance index), QUICKI (insulin sensitivity index), malondialdehyde (MDA), and high sensitivity C-reactive protein (hs-CRP) were measured at baseline and the end of trial. RESULTS: Eighty patients completed the trial. After 12-weeks of intervention, subjects in the sumac group showed a greater decrease in hepatic fibrosis and liver enzymes as well as FBS, serum insulin, HbA1c, HOMA-IR, MDA, and hs-CRP, compared to the placebo (P-value < 0.05); while the QUICKI was significantly higher in the sumac group at the end of intervention. CONCLUSION: Daily intake of 2000 mg sumac powder along with a low-calorie diet for 12 weeks was beneficial for the management of NAFLD.

Effects of vitamin D3 supplementation on clinical symptoms, quality of life, serum serotonin (5-hydroxytryptamine), 5-hydroxy-indole acetic acid, and ratio of 5-HIAA/5-HT in patients with diarrhea-predominant irritable bowel syndrome: A randomized clinical trial.

Vitamin D deficiency, common in the population with irritable bowel syndrome (IBS), can induce the main factors that lead to IBS clinical symptoms, such as depression, anxiety, and inflammation. Serotonin (5-HT) plays an important role in the pathophysiology of IBS, and its production and secretion are increased from the lumen due to stress and inflammation. The aim of this study was to evaluate the effect of vitamin D3 supplementation on the pathogenesis of diarrhea-predominant IBS (IBS-D). Seventy-four IBS-D patients (age: 18-65 y) participated in a randomized, double-blind, placebo-controlled trial study from February 2017 to May 2018, at Rasoul-e-Akram Hospital, Tehran, Iran. Subjects were allocated into two groups receiving 50,000 IU/week of vitamin D3 or placebo for 9 weeks. IBS severity score system (IBS-SSS), IBS-quality of life questionnaire (QoL), hospital anxiety and depression Scale (HADs), visceral sensitivity index (VSI) and serum 25(OH) vitamin D3, serotonin, 5-hydroxy-indole acetic acid and ratio of 5-HIAA/5-HT were evaluated before and after the interventions. Symptoms severity, QoL, HADs-depression, and VSI score improved significantly in the vitamin D group as compared to the placebo group (P-values: <0.001, 0.049, 0.023, and 0.008; respectively). There were no significant differences in abdominal bloating, HADs-anxiety, serum 5-HT, 5-HIAA, and 5-HIAA/5-HT between the two groups at the end of the study. Based on our results, we recommend serum vitamin D be evaluated in the process of treatment of these patients to ameliorate symptoms and quality life of IBS-D patients with vitamin D deficiency and/or insufficiency.

Auriculotherapy as a means of managing nausea and vomiting in pregnancy: A double-blind randomized controlled clinical trial.

INTRODUCTION: This study was aimed to assess the effectiveness of auriculotherapy on managing nausea and vomiting during pregnancy. METHODS: In this randomized clinical trial, 128 pregnant women suffering from nausea and vomiting were selected and assigned to study groups. The data were collected using demographic information and Rhodes' questionnaires and analyzed in SPSS v.22. RESULTS: After intervention, the average nausea score of the Rhodes index declined significantly in patients in the intervention group (p < 0.001).However, there was no significant (p = 0.305) difference between the two groups regarding vomiting. The results of the repeated measures showed that interventions had a significant effect on the total score of the questionnaire and also the scores regarding nausea (p < 0.04). CONCLUSION: The appropriate use of effective points on ears to control nausea and vomiting as a non-medicine and complementary treatment can alleviate nausea among pregnant women.

Improvement of NRF2 gene expression and antioxidant status in patients with type 2 diabetes mellitus after supplementation with omega-3 polyunsaturated fatty acids: A double-blind randomised placebo-controlled clinical trial.

BACKGROUND: Nrf2 is a transcription factor that induces the expression of several proteins with antioxidant properties such as sestrin2 (Sesn2) and is therefore considered as the major regulator of anti-oxidative defence system. OBJECTIVES: The aim of this research was to study the effect of supplementation with n-3 PUFAs on the antioxidant status and the gene expression of Nrf2 and Sestrin2 (Sesn2) in patients with type 2 diabetes mellitus (T2DM). PARTICIPANTS: Sixty patients with T2DM were enrolled in a placebo-controlled, double-blind, randomised clinical trial. INTERVENTION AND DESIGN: The participants were randomly allocated to two intervention groups receiving either n-3 PUFAs (2,700 mg/day) (n = 30) or placebo soft gels containing 900 mg of edible paraffin (n = 30). The main outcome measures were the expression of Sesn2 and Nrf2 genes which were assessed in peripheral blood mononuclear cells (PBMCs) after RNA extraction and cDNA synthesis by real-time PCR. Total antioxidant status in plasma samples was also measured based on the ferric reducing ability of plasma. RESULTS: NRF2 gene expression was significantly increased in n-3 PUFA-supplemented subjects, compared with the placebo group. Plasma total antioxidant status was also significantly augmented in n-3 PUFA-supplemented subjects. SESN2 gene expression was not significantly affected by n-3 PUFA supplementation although a slight up-regulation was observed. CONCLUSION: Supplementation with n-3 PUFAs enhanced NRF2 gene expression and improved overall antioxidant capacity and thus might be considered beneficial in the amelioration of oxidative stress and prevention of T2DM complications. TRIAL REGISTRATION: IRCT20150926024198N4.

Vitamin D3 Supplementation in Diarrhea-Predominant Irritable Bowel Syndrome Patients: The Effects on Symptoms Improvement, Serum Corticotropin-Releasing Hormone, and Interleukin-6 - A Randomized Clinical Trial.

OBJECTIVES: This study aimed to evaluate whether vitamin D deficiency is associated with the severity of symptoms of irritable bowel syndrome (IBS) patients. Stress and gut inflammation can increase the serum level of corticotropin-releasing hormone (CRH) and interleukin-6 (IL-6), leading to a change in bowel movements. The aim of this study was to evaluate the anti-inflammatory and psychological effects of vitamin D3 supplementation on the symptom improvement of patients with a diarrhea-predominant form of IBS (IBS-D). METHODS: Eighty-eight IBS-D patients (age: 18-65 years) based on Rome IV criteria who suffered from vitamin D deficiency and/or insufficiency were enrolled in this randomized, placebo-controlled trial from February 2017 to May 2018 at Rasoul-e-Akram Hospital, Tehran, Iran. Participants were randomly divided into two groups. The intervention group received 50,000 IU vitamin D3 weekly and the control group received a placebo for 9 weeks. All patients received Mebeverine 135 mg twice a day besides supplementation. The IBS Severity Score System (IBS-SSS), serum 25(OH) vitamin D3, CRH, and IL-6 were measured before and after interventions. RESULTS: Seventy-four patients completed the study. The severity of IBS symptoms (p < 0.01) and IL-6 (p = 0.02) decreased significantly in the intervention group as compared to the control group, but there was no significant difference in the serum level of CRH. Also, in the treatment group, IBS-SSS and IL-6 were significantly reduced at the end of the study from baseline (p < 0.01 and p < 0.03, respectively). CONCLUSION: Our findings indicate that vitamin D3 supplementation can modulate the serum level of CRH and IL-6 and can improve symptoms in IBS-D patients. Vitamin D3 supplementation should be considered in IBS-D patients who suffer from vitamin D deficiency and/or insufficiency.

Vitamin D supplementation improves SIRT1, Irisin, and glucose indices in overweight or obese type 2 diabetic patients: a double-blind randomized placebo-controlled clinical trial.

BACKGROUND: Vitamin D (VD) may increase sirtuin 1 (SIRT1) and subsequently PPAR-γ coactivator 1α (PGC-1α) and irisin levels and these improvements may reduce insulin resistance (IR). The aim was to assess the effects of vitamin D supplementation on SIRT1, irisin, and IR in overweight/obese type 2 diabetes (T2D) patients. METHODS: Ninety T2D males and females were recruited as a clinical trial study (mean of age and body mass index (BMI) of intervention and placebo groups were 50.05 ± 10.17 and 50.36 ± 10.2 yrs. and 31.37 ± 3.4 and 30.43 ± 3.2 kg/m2, respectively). The inclusion criteria were T2D, VD deficient, BMI > 25 kg/m2, and serum HbA1c < 8.5%. The exclusion criteria were using vitamin and mineral supplements, having any acute disease, recent modifying dose or type of drugs. The supplementation was 50,000 IU/week VD or placebo for 8 weeks. The demographic characteristics, anthropometrics, dietary intakes and physical activity status, sun exposure status, fasting blood sugar (FBS) and insulin, glycosylated hemoglobin (HbA1c), irisin, SIRT1, 25-hydroxy D3 (25(OH)VD), homeostasis model assessment of insulin resistance (HOMA-IR), and quantitative insulin sensitivity check index (QUICKI) were determined. The significant P-value was ≤0.05. RESULTS: The increase of serum VD, SIRT1, and irisin in the intervention group was significant (p < 0.001). HbA1c was decreased significantly by 1%. The changes in the other glucose indices (FBS, insulin, and IR) were non-significant. CONCLUSIONS: VD supplementation may improve T2D by decreasing HbA1c and increasing SIRT1 and irisin in VD deficient T2D patients. Further trials are suggested. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT201604202365N11. Registered 21/08/2016, http://en.irct.ir/trial/2019.

The Effects of Synbiotic Supplementation on Antioxidant Capacity and Arm Volumes in Survivors of Breast Cancer-Related Lymphedema.

Background and Aims: Synbiotics found to be beneficial in breast cancer survivors (BCSs) through its antioxidant properties. The aim of this study was to assess the effects of synbiotic supplementation on edema volume and some oxidative markers among obese and overweight patients with BCRL.Method: This randomized double-blind, placebo-controlled trial was conducted on 88 overweight and obese BCSs aged 18-65 years. All the subjects were given a specified low-calorie diet (LCD) and were randomly assigned into two groups to intake 109 CFU/day synbiotic supplement (n = 44) or placebo (n = 44) for 10 wk. Edema volume and serum total antioxidant capacity (TAC), malondialdehyde (MDA), glutathione peroxidase (GPx), and superoxide dismutase (SOD) concentration were measured at baseline and after the 10-wk intervention.Results: Ten-wk supplementation with synbiotics leads to a significant reduction in serum MDA levels (P = 0.001) and an increase in serum SOD concentration (P = 0.007) compared to placebo. No significant changes were observed in serum GPx, TAC, and edema volume between groups.Conclusion: Our findings reveal that 10-wk synbiotic supplementation along with a LCD program-reduced serum MDA levels and elevate the activity of SOD in overweight and obese patients with BCRL. However, its effect on serum GPx, TAC, and edema volume was not significant.

The effect of quercetin on iron overload and inflammation in ß-thalassemia major patients: A double-blind randomized clinical trial.

OBJECTIVES: The aim of this study was to determine whether quercetin can reduce iron overload and inflammation in thalassemic patients. METHODS: Eighty four patients were recruited to this study and randomly assigned to two groups: 42 patients received a 500 mg/day quercetin tablet and 42 others took a 500 mg/day starch placebo for 12 weeks. Demographic, anthropometric and biochemical evaluation were performed. RESULTS: ANCOVA analysis revealed that compared to the control group, quercetin could reduce high sensitivity C-reactive protein (hs-CRP) (P = 0.046), iron (p = 0.036), ferritin (p = 0.043), and transferrin saturation (TS) (p = 0.008) and increase transferrin (p = 0.045) significantly, but it had no significant effect on total iron binding capacity (TIBC) (p = 0.734) and tumor necrosis factor α (TNF-α) (p = 0.310). CONCLUSIONS: Quercetin could ameliorate the iron status in thalassemia major, but its effect on inflammation is indistinctive.