The effect of vitamin D supplementation on body composition in nursing mothers with overweight or obesity: a randomized double-blind placebo-controlled clinical trial.

BACKGROUND: This study aimed to evaluate the effect of vitamin D3 supplementation on body composition and anthropometric measures of nursing mothers. METHODS: In a double-blind, randomized clinical trial, 90 nursing mothers with overweight or obesity were randomized into three groups for 12 weeks: two groups of vitamin D3 supplementation (2000 IU/d (VD1), n = 32 and 4000 IU/d (VD2), n = 29) and placebo (PL) group (n = 29). The information on body composition was obtained using the body impedance analysis (BIA) method. Serum 25-Hydroxy vitamin D (25(OH) D), Intact Parathyroid Hormone (iPTH), calcium, and phosphorus were measured before and after the intervention. Data were analyzed based on the intention-to-treat (ITT) method. Two-way repeated measure ANOVA (mixed ANOVA) was applied to assess whether the mean changes in the results from baseline to 12 weeks differ in the three groups. RESULTS: There was a significant increase in the serum 25(OH) D concentration in the VD2 group compared to VD1 and PL groups (mean change (MC), 12.3 ng/ml; 95% CI, 9.4/15.0, p-value < 0.001). In addition, fat mass (MC, - 4.3 kg; 95% CI, - 7.0/- 1.1, p-value < 0.007), fat mass index (MC, - 1.6; 95% CI, - 2.6/- 0.5, p-value < 0.006) and body fat percentage (MC, - 8.1; 95% CI, - 12.0/- 4.2, p-value < 0.007) reduced in VD2 group as compared with VD1 and PL groups. CONCLUSION: The intake of 4000 IU/d vitamins D3 supplementation would elevate circulating 25(OH) D concentrations in nursing mothers with overweight or obesity and improve some indices of body composition. TRIAL REGISTRATION: Iranian Registry of Clinical Trials ( http://www.irct.ir : IRCT20140413017254N6) registered on 11-04-2018. The graphical abstract of this clinical trial, is a figure that explains the final results of the manuscript in a clear and attractive way.

The effects of green cardamom supplementation on blood pressure and endothelium function in type 2 diabetic patients: A study protocol for a randomized controlled clinical trial.

INTRODUCTION: Cardamom possesses antioxidant, anti-inflammation, and blood pressure lowering properties, which might improve endothelial function in type 2 diabetic patients. However, no study has examined the effect of cardamom on diabetic patients. The present study aimed to examine the effects of 10-week green cardamom intake on blood pressure, concentrations of inflammatory and endothelial function biomarkers in type 2 diabetes mellitus patients, and its potential mechanisms. METHODS AND ANALYSIS DESIGN: Eighty overweight or obese patients with type 2 diabetes mellitus (aged 30-60 years) will be recruited into the trial and will assign to receive either cardamom (3 g/day, 6 capsules) or placebo (rusk powder, 6 capsules) for a period of 10 weeks. Systolic blood pressure and diastolic blood pressure, asymmetric dimethylarginine, and nitric oxide will be measured. Serum inflammatory markers namely interleukin 6, tumor necrosis factor-α, high-sensitivity C-reactive protein, and factors related to endothelial function including intercellular adhesion molecule-1, vascular cell adhesion molecule 1, CD62 antigen-like family member E, and cluster of differentiation 163 will be measured at baseline and at the end of the trial. Sociodemographic, International Physical Activity Questionnaire, and three 24-hour dietary recall questionnaires will be collected for each participant. ETHICS AND DISSEMINATION: The study has been approved by The Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.REC.1395.2700). Each participant will sign a written informed consent at the beginning of the study. At the end of the study, results will be published timely manner. TRIAL REGISTRATION NUMBER: (http://www.irct.ir, identifier: IRCT-2016042717254N5) Date of registration: 2016-11-23.

Beneficial effects of nano-curcumin supplement on depression and anxiety in diabetic patients with peripheral neuropathy: A randomized, double-blind, placebo-controlled clinical trial.

Depression in patients with diabetes is associated with poor glycemic control and linked to an increased risk for diabetes complications such as neuropathy. Curcumin has shown potential antidepressant-like activities in some studies. The present study is the first randomized controlled trial to test the efficacy of nano-curcumin supplementation on depression, anxiety, and stress in patients with diabetic polyneuropathy. Eighty patients with diabetes were enrolled in this parallel, double-blind, randomized, placebo-controlled clinical trial. The participants were allocated randomly to the intervention (n = 40) and control (n = 40) groups. They received 80 mg of nano-curcumin or placebo capsules daily for 8 weeks. At baseline and end of study, anthropometric measurements, dietary intake, physical activity, glycemic indices, and severity of neuropathy were assessed. The depression, anxiety, and stress level were measured by Depression, Anxiety, Stress Scale (DASS-21-items) questionnaire before and after the intervention. After intervention, there was a significant reduction in the mean score of depression in the nano-curcumin group (from 16.7 [3.1] to 15.3 [2.6]) compared with placebo group (17.5 [3.2] to 17.3 [3.1]; p = .02). In addition, a significant fall was found in the mean score of anxiety in the nano-curcumin group (from 22.4 [4.03] to 20.6 [3.4]) compared with the placebo group (21.9 [3.5] to 21.2 [3.5]; p = .009). Changes in stress score were not statistically significant between the two groups. These findings suggested that nano-curcumin supplementation for 8 weeks was effective in reducing depression and anxiety scores in patients with diabetic polyneuropathy.

Effects of DHA-enriched fish oil on gene expression levels of p53 and NF-κB and PPAR-γ activity in PBMCs of patients with T2DM: A randomized, double-blind, clinical trial.

BACKGROUND AND AIMS: Omega-3 polyunsaturated fatty acids (PUFAs) are natural peroxisome proliferator-activated receptor gamma (PPAR-γ) ligands. Activated PPAR-γ protects the cardiovascular system against atherosclerotic lesion formation and exerts its anti-inflammatory role by suppressing cytokines induced by nuclear factor kappa-B (NF-κB) in endothelial cells (ECs), and it is hypothesized that apoptosis and cell cycle arrest induced by PPAR-γ ligands may be mediated by the p53-dependent pathway. The aim of our study was to investigate the effects of docosahexaenoic acid (DHA)-enriched fish oil supplement on PPAR-γ activity and mRNA expression levels of p53 and NF-κB. METHODS AND RESULTS: Fifty patients with type 2 diabetes mellitus (T2DM) aged 30-70 years were randomly assigned to receive either 2400 mg/d DHA-rich fish oil or placebo for 8 weeks. Metabolic parameters were assessed at baseline and at the end of the intervention. PPAR-γ activity in the peripheral blood mononuclear cells (PBMCs) was measured using ELISA-based PPAR-γ Transcription Factor Assay Kit, and the gene expression levels of p53 and NF-κB were assessed using real-time quantitative reverse transcription polymerase chain reaction (RT-PCR). On the basis of our finding, 8 weeks of treatment with DHA-rich fish oil increased PPAR-γ activity in PBMCs of subjects with T2DM (p < 0.01) compared to that in placebo (p = 0.4). Between-group comparisons of mean PPAR-γ activity changes showed significant differences (p = 0.03), whereas mRNA expression levels of the p53 and NF-κB genes did not show significant differences between studied groups (p = 0.2 and p = 0.5, respectively). CONCLUSION: Our findings indicated that short-term DHA-rich fish oil supplementation may modulate PPAR-γ activity in PBMCs.

The effect of different amounts of vitamin D supplementation on serum calcidiol, anthropometric status, and body composition in overweight or obese nursing women: a study protocol for a randomized placebo-controlled clinical trial.

BACKGROUND: The optimal vitamin D intake for nursing mothers with overweight or obesity has not been defined. Vitamin D concentrations are associated with body composition indices, particularly body fat mass. Few studies have investigated the relationship between hypovitaminosis D, obesity, anthropometric status, and body composition in nursing women. Thus, the present study aims to investigate whether vitamin D supplementation during lactation will improve vitamin D status, reduce body fat mass, and improve body composition. METHODS/DESIGN: In a double-blind, randomized, placebo-controlled, parallel-group trial, after term delivery, 90 healthy women with overweight or obesity will be selected and randomly allocated into three groups to receive 2000 IU/d cholecalciferol (vitamin D3), 4000 IU/d cholecalciferol, or placebo (lactose) for 12 weeks while nursing. Measurements of height, weight, waist circumference, and body composition (fat mass (kg), lean mass (kg), body fat (%), fat mass index, and relative fat mass index) will be taken for all subjects at baseline and after 12 weeks of intervention. In addition, serum 25-hydroxyvitamin D (25(OH)D), parathyroid hormone, calcium, and phosphorus will be measured. DISCUSSION: This study is the first investigating the effect of different amounts of vitamin D supplementation on serum calcidiol, anthropometric status, and body composition in nursing women with overweight or obesity. Our findings will contribute to the growing body of knowledge regarding the role of vitamin D supplementation in obesity, anthropometric status, and body composition in nursing women. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20140413017254N6 . Registered on 11 April 2018.

Nano curcumin supplementation reduced the severity of diabetic sensorimotor polyneuropathy in patients with type 2 diabetes mellitus: A randomized double-blind placebo- controlled clinical trial.

BACKGROUND: Diabetic Sensorimotor Polyneuropathy (DSPN) is a common complication of diabetes mellitus. Curcumin is the most important ingredient found in turmeric which has a very high potential for eliminating free radicals and inhibiting oxidative stress as an antioxidant agent. The aim of this study was to determine the effect of Nano-curcumin supplementation on the severity of sensorimotor polyneuropathy in patients with Type 2 diabetes mellitus (T2DM). METHOD: This parallel, double-blind randomized, placebo-controlled clinical trial was conducted on 80 diabetic patients. Participants were allocated randomly to the intervention (n = 40) and the control group (n = 40). They received 80 mg of nano-curcumin or placebo capsules for 8 weeks. Anthropometric measurements, dietary intake, physical activity, glycemic indices and the severity of DSPN were measured before and after the intervention. RESULT: Supplementation of nano curcumin was accounted for a significant reduction in Glycated hemoglobin(HbA1c) (p < 0.001) and Fast Blood Sugar(FBS) (p = 0.004), total score of neuropathy (p < 0.001), total reflex score (p = 0.04) and temperature (p = 0.01) compared to placebo group. CONCLUSION: Our findings indicated that curcumin supplementation for 2 months improved and reduced the severity of DSPN in patients with T2DM.

Green cardamom supplementation improves serum irisin, glucose indices, and lipid profiles in overweight or obese non-alcoholic fatty liver disease patients: a double-blind randomized placebo-controlled clinical trial.

BACKGROUND: Despite the reported health effects of cardamom on dyslipidemia, hepatomegaly, and fasting hyperglycemia, no human research has studied its potency in non-alcoholic fatty liver disease (NAFLD) as the hepatic part of metabolic syndrome. Our aim was determining the effects of green cardamom (GC) on serum glucose indices, lipids, and irisin level among overweight or obese NAFLD patients. METHODS: The place of participant recruitment was the polyclinic of the National Iranian Oil Company (NIOC) central hospital in Tehran. Based on the ultrasonography and eligibility criteria, 87 participants were randomly divided into two groups as cardamom (n = 43) or placebo (n = 44). The supplementation was two 500 mg capsules 3 times/day with meals for 3 months. Serum irisin, fasting blood sugar (FBS), insulin (FBI), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-c), and high-density lipoprotein cholesterol (HDL-c) were measured. Quantitative insulin sensitivity check index (QUICKI) and homeostasis model assessment-insulin resistance (HOMA-IR) were also calculated. RESULTS: In comparison with placebo, GC significantly increased irisin, HDL-c, and QUICKI and decreased FBI, TG, LDL-c, HOMA-IR, and the grade of fatty liver (P < 0.05). After adjustment for confounders, the changes were similar (P < 0.05) with an exception for LDL-c which had a trend (P = 0.07). The differences in FBS, TC, and body mass index (BMI) were not significant (P > 0.05). CONCLUSION: GC supplement improved the grade of fatty liver, serum glucose indices, lipids, and irisin level among overweight or obese NAFLD patients. The changes in these biomarkers may yield beneficial effects on NAFLD. Further trials on the efficacy of GC for clinical practice are suggested. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT2015121317254N4 . Registered 27/12/2015.

Higher dietary total antioxidant capacity is inversely related to prediabetes: A case-control study.

OBJECTIVES: Dietary total antioxidant capacity (DTAC) has been proposed as a tool for assessing the intake of antioxidants. The relationship between DTAC and blood glucose levels has been investigated mostly in healthy people. The aim of this study was to evaluate the association between DTAC and prediabetes morbidity in a case-control study. METHODS: We examined 300 individuals with and without prediabetes (n = 150/group) who attended a Diabetes Screening Center in Shahreza, Iran. The anthropometric measures, physical activity, and blood glucose levels of all participants were measured. Food intake over the previous year was determined using a semiquantitative food frequency questionnaire, and sex-specific, energy-adjusted DTAC was calculated using the U.S. Department of Agriculture's database. Logistic reg/ression was used to model the relationship between DTAC and prediabetes morbidity. RESULTS: The mean DTAC was significantly lower in individuals with prediabetes than in the control group (P < 0.001). Across increasing DTAC quartiles, the participants had lower fasting blood glucose and 2-h postchallenge plasma glucose (Ptrend < 0.02). After adjustment for body mass index; physical activity; education; dietary intake of fiber, fat, energy, and coffee; participants in the fourth quartile of DTAC were less likely to experience prediabetes compared with those in the first quartile (odds ratio, 0.18; 95% confidence interval, 0.07-0.49). CONCLUSION: The DTAC score appears useful when assessing the antioxidant capacity of diet and to better understand the relationship between diet and prediabetes morbidity. Future studies are needed to confirm the findings from the present study in other populations.

The effects of green cardamom supplementation on blood glucose, lipids profile, oxidative stress, sirtuin-1 and irisin in type 2 diabetic patients: a study protocol for a randomized placebo-controlled clinical trial.

BACKGROUND: It has been suggested that the antioxidant, anti-inflammatory and hypolipidemic activities of cardamom may improve diabetes. However, the effect of this spice has not been investigated in diabetic subjects. This study was planned to determine the effects of green cardamom on blood glucose, lipids and oxidative stress status in type 2 diabetic patients. METHODS/DESIGN: Eighty overweight or obese patients with type 2 diabetes will be selected. They will be randomly assigned to receive 3 g/d green cardamom or placebo for 10 weeks. The socio demographic, physical activity and 24-h food recall questionnaires will be collected for each subject. Weight, height and waist circumference will be measured. Determination of blood glucose, lipid profile, and oxidative stress biomarkers including serum levels of total antioxidant capacity (TAC), malondialdehyde (MDA), and glutathione peroxidase (GPx) and superoxide dismutase (SOD) in red blood cells will be performed. The homeostasis model assessment-estimated insulin resistance (HOMA-IR) index and the quantitative insulin-sensitivity check index (QUICKI) will be calculated. Also, serum levels of irisin, and Sirtuin1 (SIRT1) will be measured. DISCUSSION: This trial will be the first study to explore the effects of green cardamom supplementation on glycemic control, lipid profile and oxidative stress in patients with type 2 diabetes mellitus. The results from this trial will provide evidence on the efficacy of green cardamom in type 2 diabetes mellitus. TRIAL REGISTRATION NUMBER: ( http://www.irct.ir , identifier: IRCT2016042717254N5), Registration date: 23.11.2016.

DHA-enriched fish oil upregulates cyclin-dependent kinase inhibitor 2A (P16INK) expression and downregulates telomerase activity without modulating effects of PPARγ Pro12Ala polymorphism in type 2 diabetic patients: A randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE: The present study investigated the effects of docosahexaenoic acid (DHA)-enriched fish oil supplement on telomerase activity, mRNA expression of P16INK, IL-6, and TNF-α considering Pro12Ala polymorphism in the PPARγ gene. METHODS/DESIGN: In this double-blind randomized controlled trial, 72 PPARγ Pro12Ala polymorphism genotyped type 2 diabetic patients aged 30-70 years were randomly assigned to receive 2.4 gr of DHA-enriched fish oil or a placebo for 8 weeks. Genotyping of the Pro12Ala polymorphism in the PPARγ gene was assessed using polymerase chain reaction-restriction length polymorphism (PCR-RFLP), telomerase activity in the peripheral blood mononuclear cell (PBMC) was measured using PCR-ELISA based on the telomeric repeat amplification protocol (TRAP), and changes in the mRNA expression of P16, IL-6, and TNF-α were measured using real-time quantitative reverse transcription-polymerase chain reaction (RT-PCR). RESULTS: In the DHA group, telomerase activity was decreased (p = 0.001) during the intervention. In addition, between-group comparisons showed significant differences in the changes in telomerase activity (p = 0.003) and P16 mRNA expression (p = 0.028) and non-significant differences in TNF-α and IL-6 mRNA expression. The gene*DHA interaction could not affect changes in P16, IL-6, or TNF-α mRNA expression or in telomerase activity in PBMC. DISCUSSION: Short-time DHA-enriched fish oil supplementation caused increased levels of P16 expression and a decline in telomerase activity compared with the control group without modulating the effects of Pro12Ala polymorphism on the PPARγ gene. Because of the positive correlation between P16 activity and cellular senescence, the possibility of senescence stimulation by DHA is proposed.

The effects of green cardamom on blood glucose indices, lipids, inflammatory factors, paraxonase-1, sirtuin-1, and irisin in patients with nonalcoholic fatty liver disease and obesity: study protocol for a randomized controlled trial.

BACKGROUND: The relationship between dietary components and nonalcoholic fatty liver disease (NAFLD) needs to be further investigated. The potential health benefits of cardamom have been found in some studies. Cardamom showed beneficial effect on hepatomegaly, dyslipidemia, and fasting hyperglycemia in animals. However, some adverse effects of cardamom have been reported in animals. No previous human study had been conducted on the effects of cardamom in NAFLD. This study aims to determine the effects of green cardamom (Elettaria cardamomum) supplementation on blood glucose indices, lipids, inflammatory profiles, and liver function, especially by examining irisin, paraxonase-1 (PON1) and sirtuin-1 (Sirt1) in obese patients with NAFLD. METHODS: This trial is to be conducted at the polyclinic of the National Iranian Oil Company (NIOC) Central Hospital, Tehran. Eighty obese patients with NAFLD will be selected according to the eligibility criteria. The NAFLD diagnosis method is ultrasonography. Patients will be randomly divided into two groups by a random-number table (cardamom and placebo groups, two 500-mg capsules, three times/day, taken with meals for 3 months, follow-up monthly). General characteristics, dietary intakes (at the beginning, middle, and end), and physical activity (at the beginning and end) will be assessed using a general, 24-h food recall, and short-form International Physical Activity Questionnaires (IPAQ), respectively. Lifestyle advice will be presented to both groups identically. At the beginning and the end, anthropometrics (weight, height, and waist circumference), blood pressure, extent of fatty liver, and blood biomarkers, including serum glucose indices (fasting blood sugar (FBS)) and insulin (FBI), homeostasis model assessment-insulin resistance (HOMA-IR), Quantitative Insulin Sensitivity Check Index (QUICKI)), lipids (triglyceride (TG), low-density lipoprotein-cholesterol (LDL-c), high-density lipoprotein-cholesterol (HDL-c), total cholesterol (TC)), inflammatory markers (highly sensitive C-reactive protein (hs-CRP), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6)), liver enzymes (alanine transaminase (ALT), aspartate transaminase (AST)), irisin, PON1, and Sirt1, will be determined. DISCUSSION: This trial would be the first to assess the effects of green cardamom on several blood factors, including glucose indices, lipids, inflammatory markers, liver enzymes, irisin, PON1, and Sirt1, and blood pressure and anthropometry in obese patients with NAFLD. Further study of cardamom's potential in improving NAFLD is suggested. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT), ID number: IRCT2015121317254N4 . Registered on 27 December 2015.

Cardamom supplementation improves inflammatory and oxidative stress biomarkers in hyperlipidemic, overweight, and obese pre-diabetic women: a randomized double-blind clinical trial.

BACKGROUND: Several preclinical studies have shown that spices may decrease the risk of chronic diseases. However, it has been suggested that more clinical trials be carried out to strengthen this preclinical evidence. The purpose of the present study was to evaluate the effects of cardamom (Elettaria cardamomum) supplementation on inflammation and oxidative stress in hyperlipidemic, overweight, and obese pre-diabetic women. METHODS: This randomized, placebo-controlled, double-blind clinical trial was conducted on 80 pre-diabetic subjects. They randomly received the cardamom supplement (n = 40, 3 g d-1 ) or identical inert placebo (n = 40) for 8 weeks. Serum concentrations of high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), tumour necrosis factor α, total antioxidant capacity, malondialdehyde (MDA), protein carbonyl, and erythrocyte superoxide dismutase and glutathione reductase activity were analyzed at the baseline and after intervention. RESULTS: After the adjustment of some covariates, cardamom supplementation significantly decreased serum hs-CRP (P = 0.02), hs-CRP:IL-6 ratio (P = 0.008), and MDA (P = 0.009) compared with the placebo group. CONCLUSION: Cardamom could improve some parameters of inflammation and oxidative stress in pre-diabetic subjects. Thus it may be useful in reducing complications associated with inflammation and oxidative stress in these patients. Copyright © 2017 Society of Chemical Industry © 2017 Society of Chemical Industry.

Apolipoprotein A2 -265 T>C polymorphism interacts with dietary fatty acids intake to modulate inflammation in type 2 diabetes mellitus patients.

OBJECTIVE: Several investigations have been conducted regarding the interaction between Apolipoprotein A2 (APOA2) -265 T>C polymorphism and dietary intake of saturated fatty acids (SFAs) on obesity in healthy individuals or type 2 diabetes mellitus (T2 DM) patients. The aim of the present study is to examine the effect of this interaction on inflammatory markers in T2 DM patients. METHODS: This is a comparative cross-sectional study on 180 T2 DM patients with known APOA2 genotype. Dietary intake was assessed by food-frequency questionnaire and serum levels of inflammatory markers (interleukin [IL]-18, pentraxin 3, and high-sensitivity C-reactive protein [hs-CRP]) were measured. The subjects were dichotomized into "high" and "low" categories, based on the median dietary intake of polyunsaturated fatty acids (PUFAs), monounsaturated fatty acids (MUFAs), and SFAs. The data were analyzed by analysis of covariance multivariate interaction model. RESULTS: In CC genotype, higher median intake of ω-3 PUFAs and MUFAs was associated with decreased serum levels of IL-18 and hs-CRP (P = 0.014 and 0.008, respectively). In T-allele carriers, higher median intake of SFAs was associated with increased serum hs-CRP level (P < 0.001). There was a significant relationship between APOA2 polymorphism and ω-3 PUFA intake on serum IL-18 level (P interaction = 0.03). Moreover, the relationship between this polymorphism and SFA and MUFA intake on serum hs-CRP level was statistically significant (P interaction = 0.03 and 0.024, respectively). CONCLUSIONS: In T2 DM patients, the dietary intake of antiinflammatory fatty acids, such as ω-3 PUFAs and MUFAs, could reduce the inflammatory effects associated with the CC genotype. In addition, proinflammatory fatty acids, such as SFAs, could overcome the antiinflammatory effect of the T-allele. Further studies are needed to confirm these findings.

The interaction between ApoA2 -265T>C polymorphism and dietary fatty acids intake on oxidative stress in patients with type 2 diabetes mellitus.

INTRODUCTION: Apolipoprotein A2 (APOA2) -265T>C polymorphism has been studied in relation to oxidative stress and various dietary fatty acids. Since the interaction between APOA2 polymorphism and dietary fatty acids on oxidative stress has not yet discussed, we aimed to investigate the interaction on oxidative stress in type 2 diabetes mellitus (T2DM) patients. METHODS: The subjects were 180 T2DM patients with known APOA2 genotype, either TT, TC or CC. Superoxide dismutase (SOD) activity was determined by colorimetric method. Total antioxidant capacity (TAC) and serum level of 8-isoprostane F2α were measured by spectrophotometry and ELISA, respectively. Dietary intake was collected through a food frequency questionnaire. Based on the median intake, fatty acids intake was dichotomized into high or low groups. The interaction between APOA2 polymorphism and dietary fatty acids intake was analyzed by ANCOVA multivariate interaction model. RESULTS: Higher than median intake of omega-6 polyunsaturated fatty acids (n-6 PUFA) was associated with increased serum level of 8-isoprostane F2α in subjects with TT/TC genotype (p = 0.004), and higher than median intake of omega-3 polyunsaturated fatty acids (n-3 PUFA) was associated with increased serum SOD activity in CC genotype (p < 0.001). There was a statistically significant interaction between APOA2 polymorphism and n-6 PUFA intake on 8-isoprostane F2α concentration as well as n-3 PUFA intake on serum SOD activity (p-interaction = 0.04 and 0.02, respectively). CONCLUSIONS: The current study shows the interaction between APOA2 polymorphism and dietary fatty acids intake on oxidative stress. More investigations on different populations are required to confirm the interaction.

Effects of DHA-enriched fish oil on monocyte/macrophage activation marker sCD163, asymmetric dimethyl arginine, and insulin resistance in type 2 diabetic patients.

BACKGROUND: The beneficial effects of n-3 polyunsaturated fatty acids on reducing cardiovascular risks are well documented. However, the relative effect on some markers of macrophage activation and vascular function is unclear. OBJECTIVE: The primary objective of this study was to investigate the effects of docosahexaenoic acid (DHA)-enriched fish oil on the marker of monocyte/macrophage activation factor soluble CD163, asymmetric dimethyl arginine (ADMA), and insulin resistance in type 2 diabetic patients. METHODS: In this double-blind randomized controlled trial, 72 type 2 diabetic patients with an age between 30-70 years and body mass index (BMI) of 18.5 to 40 kg/m(2) were randomly assigned to receive 2.4-g DHA-enriched fish oil or placebo per day for 8 weeks. Anthropometric measurements, biochemical, and body composition analyses were assessed at baseline and end of study. Analysis of covariance (ANCOVA) was conducted by controlling for possible confounders to assess between-group differences. RESULTS: Serum levels of sCD163, triglycerides, waist circumference (WC), and weight to height ratio (WHtR) decreased significantly in the fish oil group when compared with the control group. Serum ADMA concentration decreased in the fish oil group with no significant between-group differences. Controlling for confounders revealed that the differences observed in sCD163, triglycerides, WC, and WHtR remained statistically significant. CONCLUSIONS: Short-time fish oil supplementation decreased serum sCD163, triglycerides levels, WC, and WHtR in T2DM patients. Because of the positive relationship between sCD163 levels and some T2DM and obesity-related complications, it seems that DHA can be considered as a key intervention in obesity and T2DM.

Effects of DHA Supplementation on Vascular Function, Telomerase Activity in PBMC, Expression of Inflammatory Cytokines, and PPARγ-LXRα-ABCA1 Pathway in Patients With Type 2 Diabetes Mellitus: Study Protocol for Randomized Controlled Clinical Trial.

Docosahexaenoic acid (DHA), as an omega-3 fatty acid, in a natural ligand of peroxisome proliferator-activated receptors (PPARs). Regarding the combinative effects of Nutrigenomics and Nutrigenetics and due to the lack of in vivo studies conducted using natural ligands of PPARs, we aimed to evaluate the effects of DHA supplementation on vascular function, telomerase activity, and PPARγ-LXRα-ABCA1 pathway, in patients with type 2 diabetes mellitus (T2DM), based on the Pro12Ala polymorphism in PPARγ encoding gene. 72 T2DM patients (36 dominant and 36 recessive allele carriers), aged 30-70, with body mass index of 18.5 to 35 kg/m2, will be participated in this double blind randomized controlled trial. In each group, stratification will be performed based on sex and age and participants will be randomly assigned to receive 2.4 g/day DHA or placebo (paraffin) for 8 weeks. PPARγ genotyping will be carried out using PCR-RFLP method; Telomerase activity will be estimated by PCR-ELISA TRAP assay; mRNA expression levels of target genes will be assessed using real time PCR. Serum levels of ADMA, sCD163 and adiponectin, will be measured using ELISA commercial kits. The present study is designed in order to help T2DM patients to modify their health conditions based on their genetic backgrounds, and to recommend the proper food ingredients as the natural agonists for PPARs in order to prevent and treat metabolic abnormalities of the disease.

Dietary ω-3 polyunsaturated fatty acid intake modulates impact of Insertion/Deletion polymorphism of ApoB gene on obesity risk in type 2 diabetic patients.

OBJECTIVES: The goal of the study described here was to determine whether dietary ω-3 polyunsaturated fatty acid (PUFA) intake modulates the association between ApoB Ins/Del polymorphism and obesity in type 2 diabetic patients. METHODS: In this cross-sectional study, 700 patients with type 2 diabetes were recruited in Tehran. Weight and waist circumference (WC) were measured, and body mass index (BMI) was calculated. Dietary intake was assessed using a validated semiquantitative food frequency questionnaire. ApoB genotyping was performed with 8% polyacrylamide gel electrophoresis. RESULTS: We observed a significant interaction between Ins/Del genotype and dietary ω-3 PUFA intake with respect to BMI, WC, and obesity risk in both unadjusted (P = 0.007, P = 0.001, and P = 0.021, respectively) and adjusted (P = 0.007, P = 0.04, and P = 0.002, respectively) samples. Thus, the carriers of the Del allele were only associated with lower BMI (P = 0.01) and WC (P = 0.002) among individuals with high ω-3 PUFA intake (≥0.6% of energy), but not in those with low ω-3 PUFA intake (<0.6%). Also, when dietary ω-3 PUFA was <0.6%, general obesity risk in carriers of the Del allele was about 1.6 times higher than that of Ins/Ins homozygotes (odds ratio = 1.59, 95% confidence interval: 1.05-2.52, P = 0.039). But with high ω-3 PUFA intake (≥0.6%), the risk was 0.46 times lower (odds ratio = 0.46, 95% confidence interval: 0.25-0.79, P = 0.003). Moreover, a similar interaction was observed in central obesity only in men after adjustment for confounder variables (P = 0.041). CONCLUSIONS: These findings support the hypothesis that a diet high in ω-3 PUFA (≥0.6%) can decrease the obesity risk in carriers of the Del allele of ApoB gene.

Effect of DHA-rich fish oil on PPARγ target genes related to lipid metabolism in type 2 diabetes: A randomized, double-blind, placebo-controlled clinical trial.

BACKGROUND: The beneficial effects of omega-3 polyunsaturated fatty acids on lipid levels are well documented. However, the related molecular mechanisms are widely unknown. Omega-3 polyunsaturated fatty acids are natural ligand for peroxisome proliferator-activated receptor γ (PPARγ). OBJECTIVE: The aim of this study was to evaluate the effect of docosahexaenoic acid (DHA)-rich fish oil supplementation on modulation of some PPARγ-responsive genes related to lipid metabolism. METHODS: Patients with type 2 diabetes were randomly assigned to consume either DHA-rich fish oil (containing 2400 mg/d fish oil; DHA: 1450 mg and eicosapentaenoic acid: 400 mg) or placebo for 8 weeks. Lipid profile and glycemic control parameters as well as the gene expression of PPARγ, liver x receptor-a, ATP-binding cassette A1, and CD36 in peripheral blood mononuclear cells were measured at baseline and after 8 weeks. RESULTS: DHA-rich fish oil supplementation resulted in decreased triglycerides (TG) level compared with placebo group, independently of the baseline value of TG (all patients (P = .003), hypertriglyceridemic subjects (P = .01), and normotriglyceridemic subjects (P = .02)). Moreover, a higher reduction in TG level was observed in hypertriglyceridemic subjects, comparing to normotriglyceridemic subjects with DHA-rich fish oil supplementation (P = .01). Other lipid parameters as well as the expression of PPARγ, liver x receptor-a, ATP-binding cassette A1, and CD36 were not affected by DHA-rich fish oil supplementation. Only in hypertriglyceridemic subjects, DHA-rich fish oil supplementation upregulated CD36 expression, compared with the placebo group (P = .01). CONCLUSIONS: DHA-rich fish oil supplementation for 8 weeks increased CD36 expression in hypertriglyceridemic subjects, which might result to higher reduction in TG level, comparing with normotriglyceridemic subjects. However, this finding should be investigated in further studies.

Predictors of dietary supplement usage among medical interns of Tehran university of medical sciences.

This study aimed to determine the prevalence of dietary supplement-use and its relationship with demographics and lifestyle of medical interns. The study sample comprised 356 interns aged 23 to 25 years. Participants completed a questionnaire on dietary supplement-use during the month preceding the study, information on demographic characteristics and lifestyle was also obtained. Univariable and multivariable logistic regression were employed to assess the correlates of dietary supplement-use. The prevalence of dietary supplement-use was about 33% (males 20.4% and females 43.2%, p<0.001). The most commonly-used dietary supplement was multivitamin/multivitamin-mineral (90.6% in males and 52.3% in females). Approximately 30% of supplements were used regularly (≥ 5 days/week) by all subjects. The most-frequently reported reasons for supplement-use in males were: enhancing daily energy/stamina (51.1%), poor food intake (13.3%) and, in females, were: improving health and nutritional status (39.3%) and reducing hair loss (23.4%). The decision to use dietary supplement was mostly driven by the interns themselves (56% in males, 61% in females). In the univariable analysis, men who exercised once or twice a week were less likely to use supplements compared to those who reported doing exercise more than twice weekly (OR=0.35, 95% CI 0.12-0.98). Females who reported their health status to be 'excellent' were more likely to use supplements compared to those who described their health status as 'moderate/poor/very poor' (OR=2.53, 95% CI 1.15-5.56) as were women who mentioned their breakfast consumption status as 'always' (OR=2.69, 95% CI 1.47-4.92). In the multivariable analysis, only breakfast consumption was significantly related with dietary supplement-use in females (OR=2.20, 95% CI 1.11-4.38). In conclusion, dietary supplement-use among medical interns, especially among females, was relatively very common. Dietary supplement-use was related to a healthier lifestyle.

Docosahexaenoic Acid-Rich Fish Oil Supplementation Improves Body Composition without Influence of the PPARγ Pro12Ala Polymorphism in Patients with Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

BACKGROUND: The aims of this research were to investigate (1) the impact of docosahexaenoic acid (DHA)-rich fish oil supplementation on body composition, plasma adiponectin level, and peroxisome proliferator-activated receptor γ (PPARγ) gene expression, and (2) whether the effect of DHA-rich fish oil supplementation on the aforementioned variables is modulated by PPARγ Pro12Ala polymorphism. METHODS: We genotyped PPARγ Pro12Ala polymorphism in subjects with type 2 diabetes mellitus (T2DM). Ala carriers and non-Ala carriers were randomly assigned to DHA-rich fish oil or placebo intake for 8 weeks. RESULTS: Glycemic control was not affected by the intervention. The supplementation with DHA-rich fish oil decreased waist circumference (p < 0.001), body fat mass (p = 0.01), body fat percent (p = 0.04), and viscera fat rating (p = 0.02) as well as trunk fat mass (p = 0.04). Weight, body mass index, fat-free mass, adiponectin level, and PPARγ gene expression changes showed no significant difference. No gene-diet interaction was found on body composition, adiponectin level, and PPARγ gene expression. CONCLUSIONS: DHA-rich fish oil supplementation favorably modulated body composition in patients with T2DM and could be useful to reduce visceral obesity. However, the PPARγ Pro12Ala polymorphism did not influence the changes in the desired variables.