Effects of Chromium and Carnitine Co-supplementation on Body Weight and Metabolic Profiles in Overweight and Obese Women with Polycystic Ovary Syndrome: a Randomized, Double-Blind, Placebo-Controlled Trial.

The primary aim of our study was to determine the influence of taking chromium plus carnitine on insulin resistance, with a secondary objective of evaluating the influences on lipid profiles and weight loss in overweight subjects with polycystic ovary syndrome (PCOS). In a 12-week randomized, double-blind, placebo-controlled clinical trial, 54 overweight women were randomly assigned to receive either supplements (200 µg/day chromium picolinate plus 1000 mg/day carnitine) or placebo (27/each group). Chromium and carnitine co-supplementation decreased weight (- 3.6 ± 1.8 vs. - 1.0 ± 0.7 kg, P < 0.001), BMI (- 1.3 ± 0.7 vs. - 0.3 ± 0.3 kg/m2, P < 0.001), fasting plasma glucose (FPG) (- 5.1 ± 6.0 vs. - 1.1 ± 4.9 mg/dL, P = 0.01), insulin (- 2.0 ± 1.4 vs. - 0.2 ± 1.2 µIU/mL, P < 0.001), insulin resistance (- 0.5 ± 0.4 vs. - 0.04 ± 0.3, P < 0.001), triglycerides (- 18.0 ± 25.2 vs. + 5.5 ± 14.4 mg/dL, P < 0.001), total (- 17.0 ± 20.3 vs. + 3.6 ± 12.0 mg/dL, P < 0.001), and LDL cholesterol (- 13.3 ± 19.2 vs. + 1.4 ± 13.3 mg/dL, P = 0.002), and elevated insulin sensitivity (+ 0.007 ± 0.005 vs. + 0.002 ± 0.005, P < 0.001). In addition, co-supplementation upregulated peroxisome proliferator-activated receptor gamma (P = 0.02) and low-density lipoprotein receptor expression (P = 0.02). Overall, chromium and carnitine co-supplementation for 12 weeks to overweight women with PCOS had beneficial effects on body weight, glycemic control, lipid profiles except HDL cholesterol levels, and gene expression of PPAR-γ and LDLR. Clinical trial registration number: http://www.irct.ir: IRCT20170513033941N38.

Effects of Melatonin Supplementation on Hormonal, Inflammatory, Genetic, and Oxidative Stress Parameters in Women With Polycystic Ovary Syndrome.

Purpose: The aim of the current study was to evaluate the effect of melatonin administration on clinical, hormonal, inflammatory, and genetic parameters in women with polycystic ovarian syndrome (PCOS). Methods: The present randomized, double-blinded, placebo-controlled clinical trial was conducted among 56 patients with PCOS, aged 18-40 years old. Subjects were randomly allocated to take either 5 mg melatonin supplements (n = 28) or placebo (n = 28) twice a day for 12 weeks. Results: Melatonin administration significantly reduced hirsutism (ß -0.47; 95% CI, -0.86, -0.09; P = 0.01), serum total testosterone (ß -0.11 ng/mL; 95% CI, -0.21, -0.02; P = 0.01), high-sensitivity C-reactive protein (hs-CRP) (ß -0.61 mg/L; 95% CI, -0.95, -0.26; P = 0.001), and plasma malondialdehyde (MDA) levels (ß -0.25 µmol/L; 95% CI, -0.38, -0.11; P < 0.001), and significantly increased plasma total antioxidant capacity (TAC) levels (ß 106.07 mmol/L; 95% CI, 62.87, 149.28; P < 0.001) and total glutathione (GSH) (ß 81.05 µmol/L; 95% CI, 36.08, 126.03; P = 0.001) compared with the placebo. Moreover, melatonin supplementation downregulated gene expression of interleukin-1 (IL-1) (P = 0.03) and tumor necrosis factor alpha (TNF-α) (P = 0.01) compared with the placebo. Conclusions: Overall, melatonin administration for 12 weeks to women with PCOS significantly reduced hirsutism, total testosterone, hs-CRP, and MDA, while increasing TAC and GSH levels. In addition, melatonin administration reduced gene expression of IL-1 and TNF-α. Clinical Trial Registration: www.irct.ir, identifier IRCT2017082733941N9, Available online at: https://www.irct.ir/trial/26051.

Effects of melatonin administration on mental health parameters, metabolic and genetic profiles in women with polycystic ovary syndrome: A randomized, double-blind, placebo-controlled trial.

OBJECTIVE: The aim of this study was to evaluate the effect of melatonin supplementation on mental health parameters, metabolic and genetic parameters in women suffering from polycystic ovary syndrome (PCOS). METHODS: This randomized, double-blinded, placebo-controlled clinical trial was performed on 58 subjects, aged 18-40 years old. Subjects were randomly allocated to take either 10 mg melatonin (2 melatonin capsules, 5 mg each) (n = 29) or placebo (n = 29) once a day 1 h before bedtime for 12 weeks. Glycemic control and lipid profiles were measured at baseline and after the 12-week intervention. Using RT-PCR method, gene expression related to insulin and lipid metabolism was conducted on peripheral blood mononuclear cells (PBMCs) of PCOS women. RESULTS: Melatonin supplementation significantly decreased Pittsburgh Sleep Quality Index (ß -2.15; 95% CI, -3.62, -0.68; P = 0.005), Beck Depression Inventory index (ß -3.62; 95% CI, -5.53, -1.78; P<0.001) and Beck Anxiety Inventory index (ß -1.95; 95% CI, -3.41, -0.48; P = 0.01) compared with the placebo. In addition, melatonin administration, compared with the placebo, significantly reduced serum insulin (ß -1.20 µIU/mL; 95% CI, -2.14, -0.26; P = 0.01), homeostasis model of assessment-insulin resistance (HOMA-IR) (ß -0.28; 95% CI, -0.50, -0.05; P = 0.01), serum total- (ß -7.96 mg/dL; 95% CI, -13.75, -2.17; P = 0.008) and LDL-cholesterol levels (ß -5.88 mg/dL; 95% CI, -11.42, -0.33; P = 0.03), and significantly increased the quantitative insulin sensitivity check index (QUICKI) (ß 0.008; 95% CI, 0.002, 0.014; P = 0.007). Moreover, melatonin supplementation upregulated gene expression of peroxisome proliferator-activated receptor gamma (PPAR-γ) (P = 0.004) and low-density lipoprotein receptor (LDLR) (P = 0.01) compared with the placebo. CONCLUSIONS: Overall, melatonin administration for 12 weeks had beneficial effects on mental health parameters, insulin levels, HOMA-IR, QUICKI, total- and LDL-cholesterol levels, and gene expression of PPAR-γ and LDLR among women with PCOS.

Carnitine and chromium co-supplementation affects mental health, hormonal, inflammatory, genetic, and oxidative stress parameters in women with polycystic ovary syndrome.

OBJECTIVE: The aim of this study was to evaluate the effect of the co-administration of carnitine and chromium on mental health, hormonal, inflammatory and genetic parameters in women with PCOS. METHODS: This randomized, double-blinded, placebo-controlled clinical trial was conducted on 54 subjects, aged 18-40 years old. Subjects were randomly allocated to take either 1000 mg/d carnitine plus 200 µg/d chromium as chromium picolinate (n = 26) or placebo (n = 27) for 12 weeks. RESULTS: Carnitine and chromium co-supplementation, compared with the placebo, significantly improved beck depression inventory (ß - 0.84; 95% CI, -1.51, -0.17; p = 0.01), general health questionnaire scores (ß - 1.13; 95% CI, -2.13, -0.14; p = 0.02) and depression anxiety and stress scale scores (ß - 0.96; 95% CI, -0.78, -0.14; p = 0.02). Participants who received carnitine plus chromium supplements had significantly lower total testosterone (ß - 0.15 ng/mL; 95% CI, -0.24, -0.06; p = 0.002), hirsutism (ß - 0.48; 95% CI, -0.91, -0.06; p = 0.02), high-sensitivity C-reactive protein (hs-CRP) (ß - 1.02 mg/L; 95% CI, -1.79, -0.25; p = 0.01), and malondialdehyde (MDA) levels (ß - 0.38 µmol/L; 95% CI, -0.56, -0.20; p < 0.001), and higher total antioxidant capacity (TAC) levels (ß 107.18 mmol/L; 95% CI, 44.24, 170.12; p = 0.001) compared with the placebo. Moreover, carnitine and chromium co-supplementation upregulated gene expression of interleukin-6 (IL-6) (p = 0.02) and tumor necrosis factor alpha (TNF-α) (p = 0.02) compared with the placebo. CONCLUSION: Overall, the co-administration of carnitine and chromium for 12 weeks to women with PCOS had beneficial effects on mental health parameters, serum total testosterone, mF-G scores, hs-CRP, TAC and MDA levels, and gene expression of IL-6 and TNF-α.

Comparison of myo-inositol and metformin on glycemic control, lipid profiles, and gene expression related to insulin and lipid metabolism in women with polycystic ovary syndrome: a randomized controlled clinical trial.

This investigation was conducted to evaluate comparison of myo-inositol and metformin on glycemic control, lipid profiles, and gene expression related to insulin and lipid metabolism in women with polycystic ovary syndrome (PCOS). This randomized controlled trial was conducted on 53 women with PCOS, aged 18-40 years old. Subjects were randomly allocated into two groups to take either myo-inositol (n = 26) or metformin (n = 27) for 12 weeks. Myo-inositol supplementation, compared with metformin, significantly reduced fasting plasma glucose (FPG) (ß -5.12 mg/dL; 95% CI, -8.09, -2.16; p=.001), serum insulin levels (ß -1.49 µIU/mL; 95% CI, -2.28, -0.70; p<.001), homeostasis model of assessment-insulin resistance (ß -0.36; 95% CI, -0.55, -0.17; p<.001), serum triglycerides (ß 12.42 mg/dL; 95% CI, -20.47, -4.37; p=.003) and VLDL-cholesterol levels (ß -2.48 mg/dL; 95% CI, -4.09, -0.87; p=.003), and significantly increased the quantitative insulin sensitivity check index (ß 0.006; 95% CI, 0.002, 0.01; p=.006) compared with metformin. Moreover, myo-inositol supplementation upregulated gene expression of peroxisome proliferator-activated receptor gamma (PPAR-γ) (p=.002) compared with metformin. Overall, taking myo-inositol, compared with metformin, for 12 weeks by women with PCOS had beneficial effects on glycemic control, triglycerides and VLDL-cholesterol levels, and gene expression of PPAR-γ.

The effects of vitamin D supplementation on metabolic profiles and gene expression of insulin and lipid metabolism in infertile polycystic ovary syndrome candidates for in vitro fertilization.

BACKGROUND: Vitamin D deficiency in women diagnosed with polycystic ovary syndrome (PCOS) remarkably decreases the chance of pregnancy, which might be related to its impact on metabolic abnormalities in these patients. It is hypothesized that vitamin D supplementation influences metabolic profile of these patients and indirectly might affect fertility and the outcomes. Therefore, this study was conducted to determine the effects of vitamin D supplementation on the levels of anti-Müllerian hormone (AMH), metabolic profiles, and gene expression of insulin and lipid metabolism in infertile women with PCOS who were candidate for in vitro fertilization (IVF). METHODS: This study was a randomized, double-blinded, placebo-controlled trial conducted among 40 infertile women, aged 18-40 years, diagnosed with PCOS and was candidate for IVF. Participants were randomly assigned into two intervention groups for receiving either 50,000 IU vitamin D or placebo (n = 20 each group) every other week for 8 weeks. Gene expression for insulin and lipid metabolism was conducted using peripheral blood mononuclear cells (PBMCs) of women with PCOS, via RT-PCR method. RESULTS: Vitamin D supplementation led to a significant reduction in serum AMH (- 0.7 ± 1.2 vs. - 0.1 ± 0.5 ng/mL, P = 0.02), insulin levels (- 1.4 ± 1.6 vs. -0.3 ± 0.9 µIU/mL, P = 0.007), homeostatic model of assessment for insulin resistance (- 0.3 ± 0.3 vs. -0.1 ± 0.2, P = 0.008), and a significant increase in quantitative insulin sensitivity check index (+ 0.009 ± 0.01 vs. + 0.001 ± 0.004, P = 0.04), compared with the placebo. Moreover, following vitamin D supplementation there was a significant decrease in serum total- (- 5.1 ± 12.6 vs. + 2.9 ± 10.9 mg/dL, P = 0.03) and LDL-cholesterol levels (- 4.5 ± 10.3 vs. + 2.5 ± 10.6 mg/dL, P = 0.04) compared with the placebo. CONCLUSION: Overall, the findings of this trial supported that 50,000 IU vitamin D supplementation every other week for 8 weeks had beneficial effects on insulin metabolism, and lipid profile of infertile women with PCOS who are candidate for IVF. These benefits might not be evident upon having sufficient vitamin D levels. TRIAL REGISTRATION: This study was retrospectively registered in the Iranian website ( www.irct.ir ) for clinical trials registration ( http://www.irct.ir : IRCT20170513033941N27).

Comparison of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.

INTRODUCTION: Data on comparison of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in subjects with polycystic ovary syndrome (PCOS) are scarce. This purpose of this study was to compare of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in subjects with PCOS. METHODS: This randomized controlled trial was conducted among 60 subjects diagnosed with PCOS according to the Rotterdam criteria. Subjects were randomly assigned into two groups to intake either myo-inositol (n = 30) or metformin (n = 30) for 12 weeks. Parameters of mental health were recorded at baseline and after the 12-week intervention. Fasting blood samples were obtained at baseline and the end of the study to determine biomarkers of biomarkers of oxidative stress. RESULTS: After the 12-week intervention, changes in beck depression inventory total score (-1.0 ± 1.7 vs. -0.3 ± 0.7, p = 0.03), general health questionnaire scores (-1.7 ± 2.9 vs. -0.5 ± 1.2, p = 0.02), depression anxiety and stress scale scores (-3.9 ± 6.4 vs. -0.9 ± 1.9, p = 0.01) and plasma total antioxidant capacity (TAC) concentrations (+106.1 ± 69.6 vs. +2.1 ± 132.4 mmol/L, p < 0.001) in the myo-inositol group were significantly different from the changes in these indicators in the metformin group. Myo-inositol supplementation for 12 weeks among patients with PCOS did not affect plasma glutathione and malondialdehyde levels. CONCLUSIONS: Overall, our data supported that myo-inositol supplementation for 12 weeks among patients with PCOS had favorable effects on parameters of mental health and plasma TAC levels.

The Effects of Selenium Supplementation on Gene Expression Related to Insulin and Lipid in Infertile Polycystic Ovary Syndrome Women Candidate for In Vitro Fertilization: a Randomized, Double-Blind, Placebo-Controlled Trial.

This study was conducted to evaluate the effects of selenium supplementation on gene expression related to insulin and lipid in infertile women with polycystic ovary syndrome (PCOS) candidate for in vitro fertilization (IVF). This randomized double-blind, placebo-controlled trial was conducted among 40 infertile women with PCOS candidate for IVF. Subjects were randomly allocated into two groups to intake either 200-µg selenium (n = 20) or placebo (n = 20) per day for 8 weeks. Gene expression levels related to insulin and lipid were quantified in lymphocytes of women with PCOS candidate for IVF with RT-PCR method. Results of RT-PCR demonstrated that after the 8-week intervention, compared with the placebo, selenium supplementation upregulated gene expression of peroxisome proliferator-activated receptor gamma (PPAR-γ) (1.06 ± 0.15-fold increase vs. 0.94 ± 0.18-fold reduction, P = 0.02) and glucose transporter 1 (GLUT-1) (1.07 ± 0.20-fold increase vs. 0.87 ± 0.18-fold reduction, P = 0.003) in lymphocytes of women with PCOS candidate for IVF. In addition, compared with the placebo, selenium supplementation downregulated gene expression of low-density lipoprotein receptor (LDLR) (0.88 ± 0.17-fold reduction vs. 1.05 ± 0.22-fold increase, P = 0.01) in lymphocytes of women with PCOS candidate for IVF. We did not observe any significant effect of selenium supplementation on gene expression levels of lipoprotein(a) [LP(a)] in lymphocytes of women with PCOS candidate for IVF. Overall, selenium supplementation for 8 weeks in lymphocytes of women with infertile PCOS candidate for IVF significantly increased gene expression levels of PPAR-γ and GLUT-1 and significantly decreased gene expression levels of LDLR, but did not affect LP(a). CLINICAL TRIAL REGISTRATION NUMBER: http://www.irct.ir : IRCT201704245623N113.

The Effects of Flaxseed Oil Omega-3 Fatty Acids Supplementation on Metabolic Status of Patients with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.

OBJECTIVE: This study was conducted to evaluate the effects of flaxseed oil omega-3 fatty acids supplementation on metabolic status of patients with polycystic ovary syndrome (PCOS). METHODS: This randomized double-blind, placebo-controlled trial was conducted on 60 women with PCOS according to the Rotterdam criteria aged 18-40 years old. Participants were randomly assigned into two groups to receive either 1,000 mg flaxseed oil omega-3 fatty acids (n=30) or placebo (n=30) twice a day for 12 weeks. Metabolic, endocrine, inflammatory factors were quantified at baseline and after the 12-week intervention. RESULTS: After the 12-week intervention, compared to the placebo, flaxseed oil omega-3 supplementation significantly decreased insulin values (-2.6±7.7 vs.+1.3±3.9 µIU/mL, P=0.01), homeostasis model of assessment-estimated insulin resistance (-0.7±1.7 vs.+0.3±0.9, P=0.01), mF-G scores (-1.2±1.7 vs. -0.1±0.4, P=0.001), and increased quantitative insulin sensitivity check index (+0.01±0.02 vs. -0.01±0.02, P=0.01). In addition, supplementation with flaxseed oil omega-3 resulted in significant decreases in serum triglycerides (-5.1±20.9 vs.+9.7±26.1 mg/dL, P=0.01), VLDL-cholesterol (-1.0±4.2 vs.+1.9±5.2 mg/dL, P=0.01) and high-sensitivity C-reactive protein (hs-CRP) (-1.6±3.1 vs.+0.2±1.5 mg/L, P=0.004) compared to the placebo. We did not see any significant effect of flaxseed oil omega-3 supplementation on hormonal and other lipid profiles, and plasma nitric oxide levels. CONCLUSIONS: Overall, flaxseed oil omega-3 supplementation for 12 weeks in women with PCOS had beneficial effects on insulin metabolism, mF-G scores, serum triglycerides, VLDL-cholesterol and hs-CRP levels, but did not affect hormonal and other lipid profiles, and plasma nitric oxide levels.

The Effects of Magnesium and Zinc Co-Supplementation on Biomarkers of Inflammation and Oxidative Stress, and Gene Expression Related to Inflammation in Polycystic Ovary Syndrome: a Randomized Controlled Clinical Trial.

Magnesium and zinc are known to exert multiple beneficial effects including anti-inflammatory and antioxidant actions. To our knowledge, data on the effects of magnesium and zinc co-supplementation on biomarkers of inflammation and oxidative stress and gene expression related to inflammation in subjects of polycystic ovary syndrome (PCOS) are scarce. This study was conducted to evaluate the effects of magnesium and zinc co-supplementation on biomarkers of inflammation and oxidative stress and gene expression related to inflammation in subjects with PCOS. This randomized double-blind, placebo-controlled trial was conducted among 60 subjects with PCOS diagnosed according to the Rotterdam criteria, aged 18-40 years old. Participants were randomly assigned into two groups to take either 250 mg of magnesium oxide plus 220 mg of zinc sulfate (containing 50 mg zinc) supplements (n = 30) or placebo (n = 30) twice a day for 12 weeks. Biomarkers of inflammation and oxidative stress were assessed at baseline and at end of treatment. Gene expression related to inflammatory cytokines was assessed in peripheral blood mononuclear cells (PBMCs) of PCOS women with RT-PCR method. After the 12-week intervention, compared with the placebo, magnesium and zinc co-supplementation significantly decreased serum high-sensitivity C-reactive protein (hs-CRP) (- 1.6 ± 2.4 vs. + 0.1 ± 0.7 mg/L, P = 0.001) and protein carbonyl (PCO) (- 0.14 ± 0.28 vs. + 0.02 ± 0.07 mmol/mg protein, P = 0.002) and significantly increased plasma total antioxidant capacity (TAC) levels (+ 60.7 ± 69.4 vs. - 1.5 ± 141.5 mmol/L, P = 0.03). Results of RT-PCR demonstrated that compared with the placebo, magnesium and zinc co-supplementation downregulated gene expression of interleukin-1 (IL-1) (P = 0.007) and tumor necrosis factor alpha (TNF-α) (P = 0.03) in PBMCs of subjects with PCOS. Overall, magnesium and zinc co-supplementation, compared with the placebo, for 12 weeks among PCOS women had beneficial effects on serum hs-CRP, plasma PCO, TAC, and gene expression of IL-1 and TNF-α. CLINICAL TRIAL REGISTRATION NUMBER: http://www.irct.ir : IRCT201706075623N121.

Effect of Two Different Doses of Vitamin D Supplementation on Metabolic Profiles of Insulin-Resistant Patients with Polycystic Ovary Syndrome.

This study was carried out to evaluate the effects of vitamin D supplementation on the metabolic profiles of insulin-resistant subjects with polycystic ovary syndrome (PCOS). This randomized double-blind, placebo-controlled trial was conducted on 90 insulin-resistant women with PCOS. Participants were randomly assigned to three groups to intake either 4000 IU of vitamin D or 1000 IU of vitamin D or placebo (n = 30 each group) daily for 12 weeks. Vitamin D supplementation (4000 IU), compared with vitamin D (1000 IU) and placebo, led to significant reductions in total testosterone (-0.2 ± 0.2 vs. -0.1 ± 0.6 and +0.1 ± 0.2 ng/mL, respectively, p = 0.02), free androgen index (FAI) (-0.06 ± 0.12 vs. -0.02 ± 0.12 and +0.004 ± 0.04, respectively, p = 0.04), hirsutism (-1.1 ± 1.1 vs. -0.8 ± 1.2 and -0.1 ± 0.4, respectively, p = 0.001) and high-sensitivity C-reactive protein (hs-CRP) (-0.7 ± 1.4 vs. -0.5 ± 0.9 and +0.5 ± 2.4 mg/L, respectively, p = 0.01). In addition, we found significant elevations in mean change of sex hormone-binding globulin (SHBG) (+19.1 ± 23.0 vs. +4.5 ± 11.0 and +0.7 ± 10.4 nmol/L, respectively, p < 0.001) and total antioxidant capacity (TAC) (+130 ± 144 vs. +33 ± 126 and -36 ± 104 mmol/L, respectively, p < 0.001) in the high-dose vitamin D group compared with low-dose vitamin D and placebo groups. Overall, high-dose vitamin D administration for 12 weeks to insulin-resistant women with PCOS had beneficial effects on total testosterone, SHBG, FAI, serum hs-CRP and plasma TAC levels compared with low-dose vitamin D and placebo groups.

Effect of Two Different Doses of Vitamin D Supplementation on Metabolic Profiles of Insulin-Resistant Patients with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.

The current study was conducted to evaluate the effects of 2 different doses of vitamin D supplementation on metabolic profiles of insulin-resistant patients with polycystic ovary syndrome (PCOS). This randomized double-blind, placebo-controlled trial was performed on 90 insulin-resistant patients with PCOS according to the Rotterdam criteria aged 18-40 years old. Participants were randomly allocated into 3 groups to receive either 4 000 IU of vitamin D (n=30) or 1 000 IU of vitamin D (n=30) or placebo (n=30) per day for 12 weeks. Vitamin D supplementation (4 000 IU), compared with vitamin D (1 000 IU) and placebo, led to reduced fasting plasma glucose (-4.3±8.6 vs. -4.7±7.1 and +0.1±6.7 mg/dl, respectively, p=0.02), serum insulin concentrations (-2.7±2.7 vs. -1.4±4.2 and -0.1±4.1 µIU/ml, respectively, p=0.02), and HOMA-IR (-0.6±0.6 vs. -0.4±1.0 and -0.1±0.9, respectively, p=0.02). In addition, we found significant decreases in mean change of serum triglycerides (-10.3±7.3 vs. -3.6±14.5 and +6.9±23.8 mg/dl, respectively, p=0.001), VLDL- (-2.0±1.5 vs. -0.7±2.9 and +1.4±4.8 mg/dl, respectively, p=0.001), total- (-14.0±9.5 vs. -6.2±24.0 and +7.1±29.7 mg/dl, respectively, p=0.002), LDL- (-10.8±8.3 vs. -5.7±21.9 and +6.8±28.2 mg/dl, respectively, p=0.005), and total-/HDL-cholesterol ratio (-0.2±0.3 vs. -0.1±0.6 and +0.2±0.7 mg/dl, respectively, p=0.003) in the high-dose vitamin D group compared with low-dose vitamin D and placebo groups. Overall, vitamin D supplementation at a dosage of 4 000 IU/day for 12 weeks in insulin-resistant patients with PCOS had beneficial effects of glucose metabolism and lipid profiles compared with 1 000 IU/day of vitamin D and placebo groups.

The Effects of Omega-3 Fatty Acids and Vitamin E Co-Supplementation on Indices of Insulin Resistance and Hormonal Parameters in Patients with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.

This study was conducted to determine the effects of omega-3 fatty acids and vitamin E co-supplementation on indices of insulin resistance and hormonal parameters in women with polycystic ovary syndrome (PCOS). This randomized double-blind, placebo-controlled trial was done on 68 women diagnosed with PCOS according to the Rotterdam criteria aged 18-40 years old. Participants were randomly assigned into 2 groups to receive either 1 000 mg omega-3 fatty acids from flaxseed oil containing 400 mg α-Linolenic acid plus 400 IU vitamin E supplements (n=34) or placebo (n=34) for 12 weeks. Hormonal parameters were quantified at the beginning of the study and after 12-week intervention. After 12 weeks of intervention, compared to the placebo, omega-3 fatty acids and vitamin E co-supplementation resulted in a significant decrease in insulin (-1.0±3.5 vs. +2.7±6.6 µIU/mL, P=0.004), homeostasis model of assessment-estimated insulin resistance (-0.2±0.8 vs. +0.6±1.5, P=0.005), homeostasis model of assessment-estimated B cell function (-4.3±14.3 vs. +10.5±24.5, P=0.004) and a significant increase in quantitative insulin sensitivity check index (+0.006±0.02 vs. -0.01±0.04, P=0.008). Supplementation with omega-3 fatty acids plus vitamin E led to significant reductions in serum total testosterone (-0.5±0.7 vs. -0.1±0.5 ng/mL, P=0.008) and free testosterone (-1.2±2.1 vs. -0.2±1.7, P=0.04) compared to the placebo group. We did not observe any significant effect of omega-3 fatty acids and vitamin E co-supplementation on fasting plasma glucose and other hormonal profiles. Omega-3 fatty acids and vitamin E co-supplementation for 12 weeks in PCOS women significantly improved indices of insulin resistance, total and free testosterone.

The effects of omega-3 fatty acids and vitamin E co-supplementation on gene expression of lipoprotein(a) and oxidized low-density lipoprotein, lipid profiles and biomarkers of oxidative stress in patients with polycystic ovary syndrome.

This study was conducted to determine the effects of omega-3 fatty acids and vitamin E co-supplementation on gene expression of lipoprotein(a) (Lp[a]) and oxidized low-density lipoprotein (Ox-LDL), lipid profiles and biomarkers of oxidative stress in women with polycystic ovary syndrome (PCOS). This randomized double-blind, placebo-controlled trial was done on 68 women diagnosed with PCOS according to the Rotterdam criteria aged 18-40 years old. Participants were randomly assigned into two groups to receive either 1000 mg omega-3 fatty acids from flaxseed oil containing 400 mg α-Linolenic acid plus 400 IU vitamin E supplements (n = 34) or placebo (n = 34) for 12 weeks. Lp(a) and Ox-LDL mRNA levels were quantified in peripheral blood mononuclear cells of PCOS women with RT-PCR method. Lipid profiles and biomarkers of oxidative stress were quantified at the beginning of the study and after 12-week intervention. Quantitative results of RT-PCR demonstrated that compared with the placebo, omega-3 fatty acids and vitamin E co-supplementation downregulated expressed levels of Lp(a) mRNA (P < 0.001) and Ox-LDL mRNA (P < 0.001) in peripheral blood mononuclear cells of women with PCOS. In addition, compared to the placebo group, omega-3 fatty acids and vitamin E co-supplementation resulted in a significant decrease in serum triglycerides (-22.1 ± 22.3 vs. +7.7 ± 23.6 mg/dL, P < 0.001), VLDL- (-4.4 ± 4.5 vs. +1.5 ± 4.7 mg/dL, P < 0.001), total- (-20.3 ± 16.6 vs. +12.2 ± 26.1 mg/dL, P < 0.001), LDL- (-16.7 ± 15.3 vs. +11.9 ± 26.1 mg/dL, P < 0.001) and total-/HDL-cholesterol (-0.5 ± 0.6 vs. +0.4 ± 0.8, P < 0.001). There were a significant increase in plasma total antioxidant capacity (+89.4 ± 108.9 vs. +5.9 ± 116.2 mmol/L, P = 0.003) and a significant decrease in malondialdehyde levels (-0.3 ± 0.4 vs. -0.008 ± 0.6 µmol/L, P = 0.01) by combined omega-3 fatty acids and vitamin E intake compared with the placebo group. Overall, omega-3 fatty acids and vitamin E co-supplementation for 12 weeks in PCOS women significantly improved gene expression of Lp(a) and Ox-LDL, lipid profiles and biomarkers of oxidative stress.

The effects of coenzyme Q10 supplementation on glucose metabolism and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Data on the effects of coenzyme Q10 (CoQ10) supplementation on metabolic profiles among subjects with polycystic ovary syndrome (PCOS) are scarce. OBJECTIVE: This study was carried out to evaluate the effects of CoQ10 supplementation on glucose metabolism and lipid profiles in subjects with PCOS. DESIGN, PATIENTS AND MEASUREMENTS: This randomized, double-blind, placebo-controlled trial was conducted on 60 women diagnosed with PCOS. Subjects were randomly assigned into two groups to intake either 100 mg CoQ10 supplements (N = 30) or placebo (N = 30) per day for 12 weeks. Markers of insulin metabolism and lipid profiles were assessed at first and 12 weeks after the intervention. RESULTS: After 12 weeks of intervention, compared to the placebo, subjects who received CoQ10 supplements had significantly decreased fasting plasma glucose (-0·24 ± 0·51 vs +0·01 ± 0·44 mmol/l, P = 0·04), serum insulin concentrations (-7·8 ± 14·4 vs +6·0 ± 15·0 pmol/l, P < 0·001), the homeostasis model of assessment-estimated insulin resistance (-0·3 ± 0·6 vs +0·2 ± 0·6, P = 0·001), the homeostasis model of assessment-estimated B-cell function (-5·4 ± 9·5 vs +4·5 ± 9·9, P < 0·001) and increased the quantitative insulin sensitivity check index (+0·006 ± 0·009 vs -0·006 ± 0·01, P < 0·001). In addition, changes in serum total- (-0·10 ± 0·48 vs +0·19 ± 0·50 mmol/l, P = 0·02) and LDL-cholesterol concentrations (-0·15 ± 0·40 vs +0·14 ± 0·49 mmol/l, P = 0·01) in supplemented women were significantly different from those of women in the placebo group. When we adjusted the analysis for baseline values of biochemical parameters, age and baseline BMI, serum LDL-cholesterol (P = 0·05) became nonsignificant, and other findings did not alter. CONCLUSIONS: Overall, CoQ10 supplementation for 12 weeks among subjects with PCOS had beneficial effects on glucose metabolism, serum total- and LDL-cholesterol levels.

Effects of Zinc Supplementation on Endocrine Outcomes in Women with Polycystic Ovary Syndrome: a Randomized, Double-Blind, Placebo-Controlled Trial.

The current study was conducted to evaluate the effects of zinc supplementation on endocrine outcomes, biomarkers of inflammation, and oxidative stress in patients with polycystic ovary syndrome (PCOS). This study was a randomized double-blind, placebo-controlled trial. Forty-eight women (18-40 years) with PCOS diagnosed according to Rotterdam criteria were randomly assigned to receive either 220 mg zinc sulfate (containing 50 mg zinc) (group 1; n = 24) and/or placebo (group 2; n = 24) for 8 weeks. Hormonal profiles, biomarkers of inflammation, and oxidative stress were measured at study baseline and after 8-week intervention. After 8 weeks of intervention, alopecia (41.7 vs. 12.5%, P = 0.02) decreased compared with the placebo. Additionally, patients who received zinc supplements had significantly decreased hirsutism (modified Ferriman-Gallwey scores) (-1.71 ± 0.99 vs. -0.29 ± 0.95, P < 0.001) and plasma malondialdehyde (MDA) levels (-0.09 ± 1.31 vs. +2.34 ± 5.53 µmol/L, P = 0.04) compared with the placebo. A trend toward a significant effect of zinc intake on reducing high-sensitivity C-reactive protein (hs-CRP) levels (P = 0.06) was also observed. We did observe no significant changes of zinc supplementation on hormonal profiles, inflammatory cytokines, and other biomarkers of oxidative stress. In conclusion, using 50 mg/day elemental zinc for 8 weeks among PCOS women had beneficial effects on alopecia, hirsutism, and plasma MDA levels; however, it did not affect hormonal profiles, inflammatory cytokines, and other biomarkers of oxidative stress.

Calcium plus vitamin D supplementation influences biomarkers of inflammation and oxidative stress in overweight and vitamin D-deficient women with polycystic ovary syndrome: a randomized double-blind placebo-controlled clinical trial.

OBJECTIVE: This study was conducted to determine the effects of calcium plus vitamin D supplementation on inflammatory factors and biomarkers of oxidative stress among overweight vitamin D-deficient women with polycystic ovary syndrome (PCOS). DESIGN, PATIENTS AND MEASUREMENTS: This randomized double-blind placebo-controlled clinical trial was performed among 104 overweight vitamin D-deficient women diagnosed with PCOS aged 18-40 years. Participants were randomly divided into four groups. Group A received 1000 mg calcium daily and vitamin D placebo weekly (N = 26), group B 50000 IU vitamin D weekly and calcium placebo daily (N = 26), group C 1000 mg calcium daily plus 50000 IU vitamin D weekly (N = 26) and group D calcium placebo daily plus vitamin D placebo weekly (N = 26) for 8 weeks. Fasting blood samples were taken at baseline and 8 weeks after intervention to measure inflammatory factors and biomarkers of oxidative stress. RESULTS: After 8 weeks, individuals taking calcium plus vitamin D supplements had greater decreases in homoeostatic model assessment beta-cell function (HOMA-B) score (-11·1 vs -8·6, -3·4 and 13·7, respectively, P = 0·03), serum high-sensitivity C-reactive protein (hs-CRP) (-948·3 vs 802·3, -383·8 and 618·2 ng/ml, respectively, P = 0·04) and plasma malondialdehyde (MDA) concentrations (-0·6 vs -0·5, -0·1 and 0·6 µmol/l, respectively, P = 0·009), and significant increases in plasma total antioxidant capacity (TAC) (35·2 vs 21·1, 22·5 and -153·8 mmol/l, respectively, P = 0·006) and glutathione (GSH) levels (216·0 vs 3·9, -47·5 and -160·8 µmol/l, respectively, P = 0·001) compared with calcium alone, vitamin D alone and placebo groups. Calcium plus vitamin D cosupplementation did not influence plasma NO and catalase levels. CONCLUSIONS: We found that calcium plus vitamin D cosupplementation for 8 weeks among overweight and vitamin D-deficient women with PCOS had beneficial effects on inflammatory factor and biomarkers of oxidative stress.

Magnesium supplementation affects metabolic status and pregnancy outcomes in gestational diabetes: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: To our knowledge, prior research has not examined the effects of magnesium supplementation on metabolic status and pregnancy outcomes in maternal-child dyads affected by gestational diabetes (GDM). OBJECTIVE: This study was designed to assess the effects of magnesium supplementation on metabolic status and pregnancy outcomes in magnesium-deficient pregnant women with GDM. DESIGN: A randomized, double-blind, placebo-controlled clinical trial was performed in 70 women with GDM. Patients were randomly assigned to receive either 250 mg magnesium oxide (n = 35) or a placebo (n = 35) for 6 wk. Fasting blood samples were taken at baseline and after a 6-wk intervention. RESULTS: The change in serum magnesium concentration was greater in women consuming magnesium than in the placebo group (+0.06 ± 0.3 vs. -0.1 ± 0.3 mg/dL, P = 0.02). However, after controlling for baseline magnesium concentrations, the changes in serum magnesium concentrations were not significantly different between the groups. Changes in fasting plasma glucose (-9.7 ± 10.1 vs. +1.8 ± 8.1 mg/dL, P < 0.001), serum insulin concentration (-2.1 ± 6.5 vs. +5.7 ± 10.7 µIU/mL, P = 0.001), homeostasis model of assessment-estimated insulin resistance (-0.5 ± 1.3 vs. +1.4 ± 2.3, P < 0.001), homeostasis model of assessment-estimated ß-cell function (-4.0 ± 28.7 vs. +22.0 ± 43.8, P = 0.006), and the quantitative insulin sensitivity check index (+0.004 ± 0.021 vs. -0.012 ± 0.015, P = 0.005) in supplemented women were significantly different from those in women in the placebo group. Changes in serum triglycerides (+2.1 ± 63.0 vs. +38.9 ± 37.5 mg/dL, P = 0.005), high sensitivity C-reactive protein (-432.8 ± 2521.0 vs. +783.2 ± 2470.1 ng/mL, P = 0.03), and plasma malondialdehyde concentrations (-0.5 ± 1.6 vs. +0.3 ± 1.2 µmol/L, P = 0.01) were significantly different between the supplemented women and placebo group. Magnesium supplementation resulted in a lower incidence of newborn hyperbilirubinemia (8.8% vs. 29.4%, P = 0.03) and newborn hospitalization (5.9% vs. 26.5%, P = 0.02). CONCLUSION: Magnesium supplementation among women with GDM had beneficial effects on metabolic status and pregnancy outcomes. This trial was registered at www.irct.ir as IRCT201503055623N39.

Calcium plus vitamin D supplementation affects glucose metabolism and lipid concentrations in overweight and obese vitamin D deficient women with polycystic ovary syndrome.

BACKGROUND & AIMS: Few studies have examined the effects of calcium plus vitamin D supplementation on glucose metabolism and lipid concentrations in overweight and obese vitamin D deficient women with polycystic ovary syndrome (PCOS). This study was conducted to determine the effects of calcium plus vitamin D supplementation on glucose metabolism and lipid concentrations among overweight and obese vitamin D deficient women with PCOS. METHODS: This randomized double-blind placebo-controlled clinical trial was conducted among 104 overweight and obese vitamin D deficient women diagnosed with PCOS. Participants were randomly assigned into four groups to receive: 1) 1000 mg/d calcium + vitamin D placebo (n = 26); 2) 50,000 IU/wk vitamin D + calcium placebo (n = 26); 3) 1000 mg calcium/d + 50,000 IU/wk vitamin D (n = 26) and 4) calcium placebo + vitamin D placebo (n = 26) for 8 weeks. Fasting blood samples were taken at baseline and after 8 weeks' intervention to measure glucose metabolism and lipid concentrations. RESULTS: Calcium-vitamin D co-supplementation resulted in higher levels of serum calcium (P = 0.002) and vitamin D (P < 0.001) compared with other groups. Co-supplementation, compared with other groups, led to decreased serum insulin levels (P = 0.03), homeostasis model of assessment-insulin resistance (HOMA-IR) score (P = 0.04) and a significant rise in quantitative insulin sensitivity check index (QUICKI) (P = 0.001). Furthermore, a significant decrease in serum triglycerides (P = 0.02) and VLDL-cholesterol levels (P = 0.02) was seen following the administration of calcium plus vitamin D supplements compared with the other groups. Co-supplementation with calcium and vitamin D had no significant effects on FPG, total-, LDL-, HDL-, and non-HDL-cholesterol levels. CONCLUSIONS: In conclusion, calcium plus vitamin D supplementation for eight weeks among vitamin D deficient women with PCOS had beneficial effects on serum insulin levels, HOMA-IR, QUICKI, serum triglycerides and VLDL-cholesterol levels, but it did not affect FPG and other lipid profiles. Clinical registration numberwww.irct.ir: IRCT201309275623N10.