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Background/Objectives: Magnesium (Mg)-based food supplements contribute to the maintenance of adequate levels of Mg that are essential for overall health and well-being. The aim of this double-blind, randomized, cross-over clinical study was to assess the plasma Mg levels in volunteers following the oral administration of a magnesium-based nutraceutical ingredient, MAGSHAPETM microcapsules (Mg-MS), in comparison to other commonly used magnesium sources, including the following: Mg Oxide (MgO), Mg Citrate (Mg-C), and Mg bisglycinate (Mg-BG). Methods: A total of 40 healthy women and men were put on a low-Mg diet for 7 days, and after 8 h of fasting, a blood sample was taken from a digital puncture before (0 h) and 1 h, 4 h, and 6 h after the oral intake of each product. Results: Our results showed that the blood plasma levels of Mg increased significantly at all tested time-points after the oral intake of Mg-MS, while the blood plasma levels of Mg increased significantly only after 1 and 4 h of the oral intake of MgO and Mg-C, respectively. However, no significant increase in Mg levels was observed upon the intake of Mg-BG. Interestingly, the Mg-MS microencapsulation technology was observed to enable a sustained increase in plasma Mg levels over the duration of this study, i.e., 1, 4, and 6 h after oral intake. A direct comparison of the increase in plasma Mg levels over the 6 h period revealed that the Mg-MS microencapsulation technology significantly increased Mg bioavailability compared to the non-microencapsulated MgO. Our study also showed that, compared to the other Mg sources tested, the Mg-MS microencapsulation technology reduced adverse side effects commonly associated with Mg supplementation, specifically with regard to increased intestinal motility and sensations of gastric heaviness following oral administration. Conclusions: Altogether, this clinical study introduced MAGSHAPETM microcapsules as a bioavailable and well-tolerated alternative to existing Mg-based ingredients used in food supplements.

Background Arterial stiffness is closely related to the process of atherosclerosis, an independent cardiovascular risk factor, and predictive of future cardiovascular events and mortality. Recently, we showed that magnesium citrate supplementation results in a clinically relevant improvement of arterial stiffness. It remained unclear whether the observed effect was due to magnesium or citrate, and whether other magnesium compounds may have similar effects. Therefore, we aim to study the long-term effects of magnesium citrate, magnesium oxide and magnesium sulfate on arterial stiffness. In addition, we aim to investigate possible underlying mechanisms, including changes in blood pressure and changes in gut microbiota diversity. Methods In this randomized, double-blind, placebo-controlled trial, a total of 162 healthy overweight and slightly obese men and women will be recruited. During a 24-week intervention, individuals will be randomized to receive: magnesium citrate; magnesium oxide; magnesium sulfate (total daily dose of magnesium for each active treatment 450 mg); or placebo. The primary outcome of the study is arterial stiffness measured by the carotid–femoral pulse wave velocity (PWV c–f ), which is the gold standard for quantifying arterial stiffness. Secondary outcomes are office blood pressure, measured by a continuous blood pressure monitoring device, and gut microbiota, measured in fecal samples. Measurements will be performed at baseline and at weeks 2, 12 and 24. Discussion The present study is expected to provide evidence for the effects of different available magnesium formulations (organic and inorganic) on well-established cardiovascular risk markers, including arterial stiffness and blood pressure, as well as on the human gut microbiota. As such, the study may contribute to the primary prevention of cardiovascular disease in slightly obese, but otherwise healthy, individuals. Trial registration ClinicalTrials.gov, NCT03632590 . Retrospectively registered on 15 August 2018.

This study was conducted to investigate effects of modified palygorskite (MPal) supplementation on the laying performance, egg quality and mineral element content, immunity, oxidative status, and intestinal integrity and barrier function of laying hens. A total of 360 52-week-old Hyline Brown hens were randomly assigned into four dietary treatments for a 7-week feeding trial. The birds were fed a basal diet supplemented with 0 (control group), 0.25, 0.5, and 1 g/kg MPal, respectively. The supplementation of MPal did not alter laying performance and egg quality among groups. Compared with the control group, MPal inclusion decreased lead (Pb) content in yolks at 49 days, and either 0.5- or 1-g/kg MPal supplementation decreased Pb accumulation in yolks at 25 days and manganese (Mn) accumulation in yolks at 25 and 49 days. The contents of jejunal secretory immunoglobulin A (SIgA), ileal SIgA, and immunoglobulin G were decreased by the dietary 0.5-g/kg MPal supplementation. The supplementation of MPal also decreased malondialdehyde content in jejunum and ileum, and decreased serum diamine oxidase activity of the laying hens at 25 and 49 days. The inclusion of 0.5 and 1 g/kg MPal enhanced villus height in jejunum and ileum, and also increased the ratio of villus height to crypt depth in ileum. In conclusion, MPal supplementation decreased Pb and Mn contents in yolks, and exhibited beneficial effects on the intestinal immunity, oxidative status, and intestinal integrity and barrier function of laying hens and its optimal dosage was 0.5 g/kg.

Background Recruitment to randomised controlled trials with children is challenging. It is imperative to understand the factors that boost or hinder recruitment of children to clinical trials. We conducted a survey of facilitators and barriers to recruitment to the MAGNETIC trial, using a previously developed web-based tool. Methods MAGNETIC is a multicentre randomised trial of nebulised magnesium in acute severe asthma, recruiting 508 children from 30 UK sites. Recruiters were asked to grade a list of factors from –3 to +3 depending on whether the factor was perceived as a strong, intermediate or weak barrier (–3 to –1) or facilitator (+1 to + 3), and using (0) if it was thought to be not applicable. Free text responses were invited on strategies applied to counter the identified barriers. Results The commonly identified facilitators were motivation and experience of study teams, effective communication and coordination between teams at site and between sites and the Clinical Trials Unit, the presence of designated research nurses, good trial management, clinical trial publicity, simple inclusion criteria, effective communication with parents and presentation of trial information in a simple and clear manner. The commonly identified barriers were heavy clinical workload, shift patterns of work, Good Clinical Practice (GCP) training, inadequate number of trained staff, time and setting of consent seeking, non-availability of research staff out of hours and parents' concerns about their child taking an experimental medicine. Having a designated research nurse, arranging GCP training and trial-related training sessions for staff were the most commonly reported interventions. Conclusions This study highlights important generic and trial-specific facilitators and barriers to recruitment to a paediatric trial in the acute setting and provides information on the recruitment strategies or interventions that were applied to overcome these barriers. This information can be very useful in informing the design and conduct of future clinical trials with children, particularly in the acute or emergency setting. Trial registration ISRCTN, ISRCTN81456894 . Registered on 15 November 2007.

Magnesium, one of the basic elements for the human body, is necessary for many physiological functions. Magnesium deficiency is widely observed as a result of the reduced nutrient content of foods, over-cooking, diseases, drugs, alcohol, and caffeine consumption. Taking a dietary supplement is necessary magnesium deficiency. It has been demonstrated that absorption of organic magnesium compounds is better than absorption of inorganic compounds. The aim of this study is to investigate transitions to tissues of different organic magnesium compounds in different doses and whether there is a difference in the organic acid–bounded compounds (magnesium citrate and magnesium malate) and the amino acid–bounded compounds (magnesium acetyl taurate and magnesium glycinate), associated with transition and bioavailability. In addition, the effects of split dosages of high doses in a high volume of solvent on tissue magnesium levels are being investigated, because galenic formulation problems are regarded to prepare convenient dosage that can be taken once a day. All magnesium compounds were administered as three different doses, 45, 135, and 405 mg/70 kg elemental magnesium, were given per orally to Balbc mice. In a second set of experiments, 405 mg/70 kg high dose was divided into two doses of 202.5 mg/70 kg each and administered every 12 h. Brain, muscle tissues, and serum magnesium levels measured in all experimental groups and control 24 h later. Brain magnesium levels were found increased in all magnesium acetyl taurate administered subjects. Magnesium citrate increased muscle and brain magnesium levels in a dose-independent manner. We showed that dividing high doses of daily administered magnesium compounds did not sufficiently increase tissue magnesium levels. Although passive paracellular mechanism by solvent drag is the main mechanism of Mg absorption, other factors (electrochemical gradient effects, transcellular transporter mechanisms, magnesium status) should be effective on our results. It is necessary for further research on long-term administration of different magnesium compounds and their effect on other tissues.

Although intake of minerals has been suggested to be beneficial against depression, epidemiologic data from free-living settings are limited. The aim of this study was to determine the cross-sectional associations between the intake of magnesium, calcium, iron, and zinc and the prevalence of depressive symptoms in Japanese employees. Participants were 1792 men and 214 women ages 19 to 69 y. Dietary intake was assessed using a validated, brief self-administered diet history questionnaire. Participants with depressive symptoms were defined as those with a scale score of ≥16 on the Center for Epidemiologic Studies Depression Scale. The prevalence of depressive symptoms was 27.8%. Intakes of magnesium, calcium, iron, and zinc were inversely associated with the prevalence of depressive symptoms. The multivariate adjusted odds ratios (95% confidence interval) of having depressive symptoms were 0.63 (0.44–0.91), 0.64 (0.47–0.88), 0.59 (0.40–0.87), and 0.63 (0.45–0.87) in the highest versus lowest tertiles of magnesium, calcium, iron, and zinc, respectively. Results suggest that higher dietary intake of magnesium, calcium, iron, and zinc is associated with lower prevalence of depressive symptoms in Japanese employees. •In this study, we investigated the association between dietary intake of minerals and depressive symptoms among Japanese employees.•Higher intakes of magnesium, calcium, iron, and zinc were each found to be associated with a lower prevalence of depressive status.•The associations remained statistically significant after adjustment for potential dietary and non-dietary confounders.

Magnesium is an element of great importance functioning because of its association with many cellular physiological functions. The magnesium content of foods is gradually decreasing due to food processing, and magnesium supplementation for healthy living has become increasingly popular. However, data is very limited on the bioavailability of various magnesium preparations. The aim of this study is to investigate the bioavailability of five different magnesium compounds (magnesium sulfate, magnesium oxide, magnesium acetyl taurate, magnesium citrate, and magnesium malate) in different tissues. Following a single dose 400 mg/70 kg magnesium administration to Sprague Dawley rats, bioavailability was evaluated by examining time-dependent absorption, tissue penetration, and the effects on the behavior of the animals. Pharmacokinetically, the area under the curve calculation is highest in the magnesium malate. The magnesium acetyl taurate was found to have the second highest area under the curve calculation. Magnesium acetyl taurate was rapidly absorbed, able to pass through to the brain easily, had the highest tissue concentration level in the brain, and was found to be associated with decreased anxiety indicators. Magnesium malate levels remained high for an extended period of time in the serum. The commonly prescribed dietary supplements magnesium oxide and magnesium citrate had the lowest bioavailability when compared to our control group. More research is needed to investigate the bioavailability of magnesium malate and acetyl taurate compounds and their effects in specific tissues and on behavior.

Divalent cations such as calcium and ferrous sulfate interfere with the absorption of levothyroxine due to complexing. To our knowledge, the effects of magnesium on levothyroxine absorption have never been studied. The open‐label cross‐over pharmacokinetic study was conducted in 15 healthy, euthyroid adults. 1 mg of levothyroxine was administered in tablet form alone or co‐administered with either magnesium aspartate or magnesium citrate. Participants received all three treatments, separated by a washout period, but were randomly allocated 1:1:1 to one of three treatment sequences. We measured thyroxine (T4) over a 6‐h period after ingestion. The primary endpoint was the area under the curve (AUC) of thyroxine; secondary endpoints were Cmax and Tmax. Coadministration of magnesium aspartate significantly reduced thyroxine AUC by 12% (geometric mean ratio, GMR = 0.88, 95% CI 0.81–0.95, p = 0.002) and coadministration of magnesium citrate reduced thyroxine AUC non‐significantly by 7% compared with levothyroxine alone (GMR = 0.93, 95% CI 0.86–1.01, p = 0.076). Cmax was significantly reduced by 7% and Tmax was significantly increased by 17% when magnesium aspartate was co‐administered. The changes in Cmax and Tmax were smaller when magnesium citrate was co‐administered. In conclusion, magnesium reduces the absorption of levothyroxine. However, we found smaller effects compared to those already described for other divalent cations, possibly due to the liquid formulation. Hypothyroid patients should nonetheless take levothyroxine separated from magnesium‐containing formulations, especially if TSH levels are desired to be within a narrow range. If taken together, magnesium citrate may be a better option than magnesium aspartate.

PurposeTo compare MiraLAX, a hypo-osmotic lavage, and magnesium citrate (MgC), a hyper-osmotic agent for bowel preparation at CTC.Methods398 total screening CTC studies were included in this retrospective, single institution study. 297 underwent preparation with a double-dose MgC regimen (mean age, 61 ± 5.5 years; 142 male/155 female) and 101 with 8.3 oz (equivalent to 238 g PEG) of MiraLAX (mean age, 60 ± 9.6 years; 45 male/56 female). Oral contrast for tagging purposes was utilized in both regimens. Studies were retrospectively analyzed for residual fluid volume and attenuation by automated analysis, as well for subjective oral contrast coating of the normal colonic wall and polyps. 50 patients underwent successive CTC studies utilizing each agent (mean, 6.1 ± 1.7 years apart), allowing for intra-patient comparison. Chi-squared, Fisher’s exact, McNemar, and t-tests were used for data comparison.ResultsResidual fluid volume (as percentage of total colonic volume) and fluid density was 7.2 ± 4.2% and 713 ± 183 HU for the MgC cohort and 8.7 ± 3.8% and 1044 HU ± 274 for the MiraLAX cohort, respectively (p = 0.001 and p < 0.001, respectively). Similar results were observed for the intra-patient cohort. Colonic wall coating negatively influencing interpretation was noted in 1.7% of MgC vs. 6.9% of MiraLAX examinations (p = 0.008). Polyps were detected in 12% of all MgC vs. 16% of all MiraLAX CTCs (p = 0.29).ConclusionCTC bowel preparation with the hypo-osmotic MiraLAX agent appears to provide acceptable diagnostic quality that is comparable to the hyper-osmotic MgC agent, especially when factoring in patient safety and tolerance.

•Retrospective analysis of 234 patients who received intravenous magnesium for status migrainosus.•44% of patients did not require additional intramuscular medications for pain, over half of whom (59%) experienced pain reduction of 30% or more.•Patients with less severe pain tended to have a better response than patients with more severe pain. Exploratory study to investigate the effectiveness of intravenous magnesium as an abortive for status migrainosus in an outpatient infusion center, and characterize the patients who benefit from the therapy. Retrospective analysis of 234 migraine patients who received IV magnesium as a headache abortive, at the headache clinic of University of Southern California. Additional intramuscular (IM) injections for nausea (prochlorperazine, odansetron, metoclopramide) or for refractory pain (ketorolac, dexamethasone, sumatriptan, dihydroergotamine), were administered as necessary. Immediately before and after treatment, self-reported pain levels were recorded using an 11-point numeric pain rating scale (0–10). Our patient sample has a mean age of 44 years and was predominantly female (79%). 36 (19%) had migraine with aura. Overall, pain score decreased from 5.46±2.39 to 3.56 ± 2.75 (P < 0.001) after magnesium infusion. One hundred twenty-seven (54%) patients had clinically significant pain reduction, as defined by pain decrease ≥ 30%. One hundred and four patients (44%) received IV magnesium and did not require additional intramuscular (IM) medications for pain. In patients who did not receive additional IM medications for pain, pain score decreased from 4.76 ± 2.41 to 2.95 ± 2.70 (p < 0.001), and 61 out of 104 (59%) experienced ≥ 30% pain reduction. Patients with less severe pain tended to have a better response than patients with more severe pain, as patients with ≥30% pain reduction had a significantly lower pre-treatment pain score (p = 0.018). For a subset of patients with status migrainosus, IV magnesium therapy results in clinically significant pain relief without the need for intramuscular pain medications. Therefore, IV magnesium may be useful as a cost-effective first-line parental therapy for status migrainosus, especially for patients who initially present with lower pain intensity.