The effect of dietary soy intake on weight loss, glycaemic control, lipid profiles and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome: a randomised clinical trial.

BACKGROUND: The present study aimed to evaluate the effects of dietary soy intake on weight loss and metabolic status of patients with polycystic ovary syndrome (PCOS). METHODS: A randomised clinical trial was conducted among 60 women with PCOS. Participants were randomly assigned into two groups to receive either a test diet (n = 30) or a control diet (n = 30) for 8 weeks. Participants in the test group consumed a diet containing 0.8 g protein kg-1 body weight (35% animal proteins, 35% soy protein and 30% vegetable proteins) and participants in the control group consumed a similar diet containing 70% animal proteins and 30% vegetable proteins. RESULTS: Adherence to the test diet, compared with the control diet, resulted in significant decreases [mean (SD)] in body mass index (BMI) [-0.3 (0.6) versus +0.1 (0.5) kg m-2 , P = 0.02], fasting plasma glucose [-0.2 (0.5) versus +0.1 (0.3) mmol L-1 , P = 0.01], total testosterone [-0.3 (0.7) versus +0.3 (0.3) mmol L-1 , P < 0.001], insulin [-15.0 (18.0) versus +4.8 (18.6) pmol L-1 , P < 0.001] and insulin resistance [-0.6 (0.6) versus +0.2 (0.7), P < 0.001], as well as a significant increase in quantitative insulin sensitivity check index [+0.01 (0.01) versus -0.002 (0.02), P = 0.01]. In addition, significant decreases in triglycerides [-0.1 (0.4) versus +0.2 (0.3) mmol L-1 , P = 0.01] and malondialdehyde (MDA) [-1.2 (1.0) versus +0.2 (1.2) µmol L-1 , P < 0.001] and significant increases in nitric oxide (NO) [+13.6 (14.1) versus +0.9 (24.3) µmol L-1 , P = 0.01] and glutathione (GSH) [+170.1 (175.5) versus +24.2 (168.7) µmol L-1 , P = 0.002] were seen in the test group compared to the control. CONCLUSIONS: Adherence to test diet among subjects with PCOS significantly decreased BMI, glycaemic control, total testosterone, triglycerides and MDA, and significantly increased NO and GSH compared to the control diet.

Effects of probiotic supplementation on glycaemic control and lipid profiles in gestational diabetes: A randomized, double-blind, placebo-controlled trial.

BACKGROUND: To our knowledge, data on the effects of probiotic supplementation on glycaemic control and lipid concentrations in patients with gestational diabetes mellitus (GDM) are scarce. AIM: The aim of the present study was to determine the effects of probiotic supplementation on glycaemic control and lipid profiles in GDM patients. METHODS: Sixty pregnant women with GDM, primigravida and aged 18-40years, were divided into two groups to receive either probiotic capsules (n=30) or a matching placebo (n=30) in this randomized double-blind, placebo-controlled trial. The patients in the probiotic group took a daily capsule that contained three viable freeze-dried strains: Lactobacillus acidophilus (2×10(9)CFU/g), L. casei (2×10(9)CFU/g) and Bifidobacterium bifidum (2×10(9)CFU/g) for 6weeks. The placebo group took capsules filled with cellulose for the same time period. Fasting blood samples were taken at the beginning and end of the study to quantify the relevant markers. RESULTS: After 6weeks of intervention, probiotic supplementation vs a placebo resulted in significant decreases in fasting plasma glucose (-9.2±9.2mg/dL vs +1.1±12.2mg/dL, P<0.001), serum insulin levels (-0.8±3.1µIU/mL vs +4.5±10.6µIU/mL, P=0.01), homoeostasis model assessment (HOMA) for insulin resistance (-0.4±0.9 vs +1.1±2.5, P=0.003) and HOMA for ß-cell function (+1.1±9.8 vs +18.0±42.5, P=0.03), and a significant increase in the quantitative insulin sensitivity check index (+0.007±0.01 vs -0.01±0.02, P=0.007). In addition, significant decreases in serum triglycerides (-1.6±59.4mg/dL vs +27.1±37.9mg/dL, P=0.03) and VLDL cholesterol concentrations (-0.3±11.9mg/dL vs +5.4±7.6mg/dL, P=0.03) were seen following supplementation with the probiotics compared with the placebo. However, no significant changes in other lipid profiles were seen with the intervention. CONCLUSION: Overall, the results of our study have demonstrated that taking probiotic supplements for 6weeks in patients with GDM had beneficial effects on glycaemic control, triglycerides and VLDL cholesterol concentrations, although there was no effect on other lipid profiles.

The Effects of Vitamin D-K-Calcium Co-Supplementation on Endocrine, Inflammation, and Oxidative Stress Biomarkers in Vitamin D-Deficient Women with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.

The current study was conducted to assess the effects of vitamin D-K-calcium co-supplementation on endocrine, inflammation, and oxidative stress biomarkers in vitamin D-deficient women with polycystic ovary syndrome (PCOS). This randomized double-blind, placebo-controlled trial was performed on 60 vitamin D-deficient women diagnosed with PCOS aged 18-40 years old. Participants were randomly allocated into 2 groups to intake either 200 IU vitamin D, 90 µg vitamin K plus, 500 mg calcium supplements (n=30), or placebo (n=30) twice a day for 8 weeks. Endocrine, inflammation, and oxidative stress biomarkers were quantified at the beginning and the end of the study. After 8 weeks of intervention, compared with the placebo, vitamin D-K-calcium co-supplementation resulted in a significant reduction in serum-free testosterone (- 2.1±1.6 vs.+0.1±1.0 pg/ml, p<0.001) and dehydroepiandrosterone sulfate (DHEAS) levels (- 0.8±1.0 vs.-0.1±0.5 µg/ml, p=0.006). In addition, a significant increase in plasma total antioxidant capacity (TAC) (+ 75.7±126.1 vs.-80.4±242.8 mmol/l, p=0.005) and a significant difference in plasma malondialdehyde (MDA) concentrations (+ 0.03±0.6 vs.+1.4±2.4 µmol/l, p=0.005) was observed following the supplementation with vitamin D-K-calcium compared with the placebo. A trend toward a greater decrease in luteinizing hormone was observed in vitamin D-K-calcium co-supplement group compared to placebo group (- 7.0 vs.-1.2 IU/l, p=0.09). We did not find any significant effect of vitamin D-K-calcium co-supplementation on prolactin, follicle-stimulating hormone, 17-OH progesterone, inflammatory markers, and glutathione levels. Overall, vitamin D-K-calcium co-supplementation for 8 weeks among vitamin D-deficient women with PCOS had beneficial effects on serum DHEAS, free testosterone, plasma TAC, and MDA levels.

The effects of vitamin D plus calcium supplementation on metabolic profiles, biomarkers of inflammation, oxidative stress and pregnancy outcomes in pregnant women at risk for pre-eclampsia.

BACKGROUND: The present study was designed to examine the effects of vitamin D plus calcium administration on metabolic profiles and pregnancy outcomes among women at risk for pre-eclampsia. METHODS: In a prospective, double-blind, placebo-controlled trial, 60 women at risk for pre-eclampsia were randomised to take either 50 000 IU vitamin D3 every 2 weeks plus 1000 mg day(-1) calcium supplements (as calcium carbonate) (n = 30) or to receive placebos at the same times (n = 30) from 20 to 32 weeks of gestation. Fasting blood samples were taken at baseline and 12 weeks after intervention to determine related variables. Newborn anthropometric measurements were determined. RESULTS: Taking combined cholecalciferol and calcium supplements, compared to placebo, led to significant reductions in fasting plasma glucose (FPG) [mean (SD)] [-5.7 (5.5) versus -0.6 (12.6) mg dL(-1) , P = 0.04], serum insulin concentrations [-2.8 (6.0) versus +7.7 (9.8) µIU mL(-1) , P < 0.001], homeostasis model of assessment-insulin resistance [-0.8 (1.3) versus +1.6 (2.2), P < 0.001], homeostatic model assessment-beta cell function [-8.2 (25.8) versus +32.6 (41.3, P < 0.001] and a significant rise in quantitative insulin sensitivity check index score [+0.02 (0.02) versus -0.02 (0.02, P < 0.001]. Additionally, pregnant women who received cholecalciferol plus calcium supplements had increased serum high-density lipoprotein (HDL)-cholesterol [+4.6 (8.3) versus -2.9 (7.7) mg dL(-1) , P = 0.001] and plasma total glutathione (GSH) concentrations [+23.4 (124.0) versus -94.8 (130.2) µm, P = 0.001] compared to placebo. However, after adjustment for the baseline levels, maternal age and baseline body mass index, the effects on FPG levels (P = 0.13) and systolic blood pressure (P = 0.13) disappeared. CONCLUSIONS: Vitamin D plus calcium administration for 12 weeks had beneficial effects on glycaemic status, HDL-cholesterol, GSH and blood pressure among women at risk for pre-eclampsia.

Zinc Supplementation and the Effects on Pregnancy Outcomes in Gestational Diabetes: a Randomized, Double-blind, Placebo-controlled Trial.

OBJECTIVE: The current study was designed to determine the beneficial effects of zinc intake on biomarkers of inflammation, oxidative stress, and pregnancy outcomes among pregnant women with gestational diabetes (GDM). METHODS: This randomized, double-blind, placebo-controlled clinical trial was conducted among 50 women with GDM. Patients were randomly allocated to intake either 233 mg zinc gluconate (containing 30 mg zinc) (n=25) or a placebo (n=25) for 6 weeks. Fasting blood samples were taken at the fist of the study and after 6 weeks of intervention to quantify related variables. Newborn's weight, height, head circumference, Apgar score, and hyperbilirubinemia were determined. RESULTS: The change in serum zinc levels after 6 weeks of supplementation was greater in women consuming zinc than in the placebo group (+8.5±13.5 vs. -3.6±16.2 mg/dL, P=0.006). Changes in serum high sensitivity C-reactive protein (hs-CRP) (-110.1±1 475.5 vs. +1 137.8±2 429.2 ng/mL, P=0.03) and plasma total antioxidant capacity (TAC) concentrations (+60.0±129.0 vs. -28.4±81.4 mmol/L, P=0.006) were significantly different between the supplemented women and placebo group. We did not find any significant effect of zinc administration on pregnancy outcomes. CONCLUSION: Taken together, zinc administration among patients with GDM was associated with decreased hs-CRP and increased TAC concentrations; however, it did not influence maternal plasma nitric oxide (NO), glutathione (GSH), malondialdehyde (MDA) levels, or pregnancy outcomes.

Effects of High-Dose Vitamin D Supplementation on Metabolic Status and Pregnancy Outcomes in Pregnant Women at Risk for Pre-Eclampsia.

This study was designed to assess the beneficial effects of high-dose (cholecalciferol) vitamin D supplementation on metabolic profiles and pregnancy outcomes among pregnant women at risk for pre-eclampsia. This randomized double-blind placebo-controlled clinical trial was performed among 60 pregnant women at risk for pre-eclampsia according to abnormal uterine artery Doppler waveform. Subjects were randomly divided into 2 groups to receive 50 000 IU vitamin D supplements (n=30) or receive placebo (n=30) every 2 weeks from 20 to 32 weeks of gestation. Fasting blood samples were taken at baseline study and 12 weeks after the intervention to quantify relevant variables. Newborn's anthropometric measurements were determined. Pregnant women who received cholecalciferol supplements had significantly increased serum 25-hydroxyvitamin D concentrations (+17.92±2.28 vs. +0.27±3.19 ng/ml, p<0.001) compared with the placebo. The administration of cholecalciferol supplements, compared with the placebo, resulted in significant differences in serum insulin concentrations (+1.08±6.80 vs. +9.57±10.32 µIU/ml, p<0.001), homeostasis model of assessment-insulin resistance (HOMA-IR) (+0.19±1.47 vs. +2.10±2.67, p<0.001), homeostatic model assessment-beta cell function (HOMA-B) (+5.82±29.58 vs. +39.81±38.00, p<0.001) and quantitative insulin sensitivity check index (QUICKI) score (-0.009±0.03 vs. -0.04±0.03, p=0.004). Furthermore, cholecalciferol-supplemented pregnant women had increased HDL-cholesterol concentrations (+2.67 ± 8.83 vs. -3.23±7.76 mg/dl, p=0.008) compared with the placebo. Finally, cholecalciferol supplementation led to a significant rise in plasma total antioxidant capacity (TAC) concentrations (+79.00±136.69 vs. -66.91±176.02 mmol/l, p=0.001) compared with the placebo. Totally, the administration of cholecalciferol supplements among pregnant women at risk for pre-eclampsia for 12 weeks had favorable effects on insulin metabolism parameters, serum HDL-cholesterol, and plasma TAC concentrations.

Favorable effects of vitamin D supplementation on pregnancy outcomes in gestational diabetes: a double blind randomized controlled clinical trial.

Gestational diabetes mellitus (GDM) has been recognized as a significant risk factor for unfavorable pregnancy outcomes. Prevalence of vitamin D deficiency is highly prevalent among women with GDM. This study was designed to assess the effect of vitamin D supplementation on pregnancy outcomes of pregnant women with GDM who were not on oral hypoglycemic agents. This randomized controlled clinical trial was performed among 45 pregnant women diagnosed with GDM at 24-28 weeks' gestation. Subjects were randomly assigned to consume either vitamin D supplements (cholecalciferol) or placebo. Individuals in the vitamin D group (n=22) received 50 000 IU vitamin D3 pearl 2 times during the study: at study baseline and day 21 of intervention and those in placebo group (n=23) received 2 placebos at the mentioned times. Fasting blood samples were taken at baseline to measure fasting plasma glucose. Participants underwent a 3-h oral glucose tolerance tests (OGTT) and the blood samples were collected at time 60, 120, and 180 min to measure plasma glucose levels. Newborn's weight, height, head circumference, Apgar score, and hyperbilirubinemia were determined. Taking vitamin D supplements, compared with placebo, resulted in improved pregnancy outcomes; such that those in the vitamin D group had no case of polyhydramnios, while 17.4% of subjects in placebo group had this condition (p=0.04). In addition, newborn's hyperbilirubinemia was significantly lower in vitamin D group than that in placebo group (27.3% vs. 60.9%, p=0.02). In conclusion, vitamin D supplementation for 6 weeks among pregnant women with GDM resulted in decreased maternal polyhydramnios and infant hyperbilirubinemia compared with placebo. Clinical trial registration number www.irct.ir:IRCT201305115623N7.