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.

Selenium Supplementation and the Effects on Reproductive Outcomes, Biomarkers of Inflammation, and Oxidative Stress in Women with Polycystic Ovary Syndrome.

Selenium supplementation could be effective on reproductive outcomes, biomarkers of inflammation, and oxidative stress among women with polycystic ovary syndrome (PCOS). The aim of the study was to determine the effects of selenium supplementation on reproductive outcomes, biomarkers of inflammation, and oxidative stress in PCOS patients. The present randomized double-blind, placebo-controlled trial was conducted on 64 women aged 18-40 years old with PCOS at the clinic affiliated to Ardabil University of Medical Sciences, Ardabil, Iran. The participants were randomly assigned to 2 groups receiving either 200 µg selenium daily (n=32) or placebo (n=32) for 8 weeks. Hormonal profiles, biomarkers of inflammation, and oxidative stress were measured and compared both before and after the treatment. After 8 weeks of intervention, pregnancy rate in the selenium group was higher than in the placebo group: 18.8 (6/32) vs. 3.1% (1/32), p=0.04. In addition, alopecia (40.6 vs. 9.4%, p=0.004) and acne (46.9 vs. 12.5 %, p=0.003) decreased following the consumption of selenium supplements compared with placebo. Additionally, patients who received selenium supplements had significantly decreased serum dehydroepiandrosterone (DHEA) levels (p=0.02), hirsutism (modified Ferriman-Gallwey scores) (p<0.001), serum high sensitivity C-reactive protein (hs-CRP) (p=0.02), and plasma malondialdehyde (MDA) levels (p=0.01) compared with placebo. We did not observe any significant effects of taking selenium supplements on other hormonal profiles, nitric oxide (NO), and other biomarkers of oxidative stress. Taken together, selenium supplementation for 8 weeks among PCOS women had beneficial effects on reproductive outcomes, DHEA, hs-CRP, and MDA levels. Supporting Information for this article is available online at http://www.thieme-connect.de/products.

Effects of zinc supplementation on markers of insulin resistance and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: This study was conducted to evaluate the effects of zinc supplementation on glucose homeostasis parameters and lipid concentrations in PCOS women. We are aware of no study evaluating the effects of zinc supplementation on metabolic profiles of patients with polycystic ovary syndrome (PCOS). METHODS: This randomized, double-blind, placebo-controlled trial was conducted among 52 women diagnosed with PCOS and aged 18-40 years old. Participants were randomly divided into 2 groups to receive 220 mg zinc sulfate (containing 50 mg zinc) supplements (n=26) or placebo (n=26) per day for 8 weeks. Fasting blood samples were taken at baseline and after 8 weeks' intervention to quantify glucose, insulin and lipid concentrations. RESULTS: After 8 weeks of intervention, subjects who received zinc supplements had significantly increased serum zinc levels (+15.6±21.8 vs. -4.1±16.7 mg/dL, P=0.001) compared with placebo. In addition, zinc-supplemented patients had reduced fasting plasma glucose (FPG) (-4.3±9.6 vs. +0.5±6.0 mg/dL, P=0.03), serum insulin levels (-3.0±2.9 vs. +1.5±8.4 µIU/mL, P=0.01), homeostasis model of assessment-insulin resistance (HOMA-IR) (-0.8±0.8 vs. +0.3±1.9, P=0.006), homeostatic model assessment-Beta cell function (HOMA-B) (-10.6±9.5 vs. +4.9±32.1, P=0.02) and increased quantitative insulin sensitivity check index (QUICKI) (+0.02±0.02 vs. -0.004±0.05, P=0.03) compared with placebo. Additionally, a significant reduction in serum triglycerides (-15.6±40.3 vs. +14.5±25.3 mg/dL, P=0.002) and VLDL-cholesterol concentrations (-3.2±8.1 vs. +2.9±5.1 mg/dL, P=0.002) was observed following the administration of zinc supplements compared with placebo. CONCLUSION: Taken together, 220 mg zinc sulfate supplementation per day for 8 weeks among PCOS women had beneficial effects on metabolic profiles.

Entonox for labor pain: a randomized placebo controlled trial.

This study aims to investigate the effectiveness of nitrous oxide on pain of labor contractions and on maternal SaO2. The patients were randomized to receive either a pre-prepared mixture of 50% nitrous oxide and oxygen or 50% oxygen by a coin. Study drugs started as early as the onset of pain with each contraction. The patient herself administered gases via a facemask connected to the uni-directional valve which enables the patients to breathe fresh gas in each inspiration. The gas administration was continued to the end of contraction pain at which the patient breathed the room air. Variables such as SaO2, blood pressure, pain and side effects were recorded. 534 ASA I and II parturients, aged from 16 to 35 years, scheduled for elective labor from September 2004 to 2006 were evaluated. Four patients were lost from the study. The mean age of patients was 25.5+/-4.3 years. During the first three measurements, the SaO2 was significantly higher in control group. In addition, the mean arterial pressure was comparable between groups except two first measurements in which the control group was higher. All the Visual Analogue Scale (VAS) values were significantly lower in nitrous oxide group. There were no significant differences in 1st and 5th min apgar scores between groups. All of the side effects were significantly higher among patients in nitrous oxide. In conclusion, our data indicate that using nitrous oxide 50% provides significant pain relief. Nonetheless, it is associated with few side effects, nitrous oxide can be quickly implemented during advanced painful labor.