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Effects of the Lysulin™ supplementation on pre-diabetes: A randomized double-blind, placebo-controlled clinical trial.
Ranasinghe, P, Jayawardena, R, Chandrasena, L
Diabetes & metabolic syndrome. 2020;(5):1479-1486
Abstract
BACKGROUND AND AIMS Diabetes is a leading cause of morbidity and mortality worldwide. Recent studies have demonstrated that nutraceutical products have beneficial effects in diabetes. Present study aims to investigate whether a product (Lysulin™) containing amino acid lysine, micronutrient zinc and vitamin C will have beneficial effects in pre-diabetes. METHODS A randomized, double-blind, placebo-controlled trial was conducted for a period of 6 months. The two parallel groups (1:1) were Lysulin™ (Interventional group-IG) and placebo (control group-CG). Evaluations were done at baseline, 1, 3 and 6 months. Primary outcome was defined as change in glycaemic control measured by HbA1c from baseline. Other outcomes included change in; fasting plasma glucose (FPG), 2-h OGTT plasma glucose and lipid profile from baseline. Three multiple regression analyses were performed, where change in FPG, 2-h OGTT, and HbA1c post intervention from baseline respectively were the continuous dependent variable with other independent variables. RESULTS One hundred and ten participants were recruited, 50% (n = 55) were males and mean age (±SD) was 46.7 ± 9.9 years. A significantly higher percentage of participants in CG (25.4%, n = 14) developed diabetes in comparison to IG (7.3%, n = 4) (p = 0.018). FPG, 2-h OGTT and HbA1c significantly reduced in the IG only. Both total cholesterol and LDL cholesterol decreased significantly from baseline only in the IG. In all three regression models the best predictor of respective dependent variable was Lysulin™ treatment. CONCLUSIONS Lysulin™ improved glycaemic control, with reduced progression to diabetes, in those with pre-diabetes. Treatment also showed a beneficial reduction in total and LDL cholesterol levels. TRIAL REGISTRATION Sri Lanka Clinical Trials Registry, identifier: SLCTR/2018/022 (http://slctr.lk/trials/1290). Registered on 13th July 2018; Study protocol version 2.0 (23rd March 2018).
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The Association between Excess Body Mass and Disturbances in Somatic Mineral Levels.
Banach, W, Nitschke, K, Krajewska, N, Mongiałło, W, Matuszak, O, Muszyński, J, Skrypnik, D
International journal of molecular sciences. 2020;(19)
Abstract
BACKGROUND Obesity and excess body weight are significant epidemiological issues, not only because they are costly to treat, but also because they are among the leading causes of death worldwide. In 2016, an estimated 40% of the global population was overweight, reflecting the importance of the issue. Obesity is linked to metabolism malfunction and concomitantly with altered mineral levels in the body. In this paper, we review alterations in somatic levels of iron, calcium, magnesium, copper, iodine, chromium, selenium, and zinc in relation to excess body mass. METHODOLOGY An electronic literature search was performed using PubMed. Our search covered original English research articles published over the past five years, culminating in 63 papers included for study. RESULTS The reviewed papers presented correlation between obesity and hypomagnesemia and hypozincemia. They also indicated that patients with excess body mass present increased body copper levels. Studies have similarly indicated that obesity appears to be associated with lower selenium levels in both blood and urine, which may be correlated with the decline and weakening of defenses against oxidative stress. It has been found that decreased level of chromium is connected with metabolic syndrome. Chromium supplementation influences body mass, but the effect of the supplementation depends on the chemical form of the chromium. It is hypothesized that obesity poses a risk of iodine deficiency and iodine absorption may be disrupted by increased fat intake in obese women. A range of studies have suggested that obesity is correlated with iron deficiency. On the other hand, some reports have indicated that excess body mass may coexist with iron excess. The relation between obesity and body iron level requires further investigation. Calcium signaling seems to be disturbed in obesity, due to the increased production of reactive oxygen species and low level of fast troponin isoform responsible for mediating calcium sensitivity of muscle relaxation. Correlation between excess body mass and calcium levels needs further research. CONCLUSIONS Excess body mass is associated with alterations in mineral levels in the body, in particular hypomagnesemia and decreased selenium (Se) and zinc (Zn) levels. Chromium (Cr) deficiency is associated with metabolic syndrome. Obese patients are at risk of iodine deficiency. Excess body mass is associated with elevated levels of copper (Cu). Data on the association between obesity and iron (Fe) levels are contradictory. Obesity coexists with disturbed calcium (Ca) signaling pathways. The association between obesity and body Ca levels has not been investigated in detail.
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The Effect of Curcumin on Serum Copper and Zinc and Zn/Cu Ratio in Individuals with Metabolic Syndrome: A Double-Blind Clinical Trial.
Safarian, H, Parizadeh, SMR, Saberi-Karimain, M, Darroudi, S, Javandoost, A, Mohammadi, F, Moammeri, M, Ferns, GA, Ghayour-Mobarhan, M, Mohebati, M
Journal of dietary supplements. 2019;(6):625-634
Abstract
Metabolic syndrome is a complex disorder with high socioeconomic costs and a high global prevalence. The serum concentrations of some trace elements are higher in people with metabolic syndrome compared to normal individuals. Curcumin is derived from turmeric and has antioxidant and anti-inflammatory properties. Curcumin may therefore have a potential role in the management of cardiovascular risk. The aim of this study was to investigate the effects of curcumin on serum copper (Cu), zinc (Zn), and Zn/Cu ratio levels in patients with metabolic syndrome. A double-blind clinical trial was designed in which 120 individuals with metabolic syndrome were randomly assigned to one of three groups: curcumin 1gr/day, phospholipidated curcumin 1gr/day, or a placebo, each taken for 6 weeks. Serum copper and zinc were measured before and after intervention. At baseline, in addition to obtaining the anthropometric characteristics of participants, a fasting blood sample was taken from each participant, and the concentrations of serum Cu and Zn were measured by atomic absorption (Varian AA 240 FS model). Serum Zn concentrations rose significantly in the phospholipidated curcumin and curcumin groups, being significantly higher (p <.001) in the phospholipidated curcumin group than in the curcumin group (p <.05). Serum Zn concentration fell in the control group (p <.05). Changes in serum Zn level from baseline to the levels after six weeks' intervention were significantly different between the groups, but changes in serum Cu from between baseline until after intervention were not significantly different. The serum Zn/Cu level in phospholipidated curcumin and curcumin groups after intervention was higher than for the control group, but it was more significant in the group taking phospholipidated curcumin (p <.001). Curcumin and phospholipidated curcumin complex, given at a dose of 1 g per day for six weeks, were associated with an increase in serum zinc and consequently zinc-to-copper ratio.
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Changes in zinc status and zinc transporters expression in whole blood of patients with Systemic Inflammatory Response Syndrome (SIRS).
Florea, D, Molina-López, J, Hogstrand, C, Lengyel, I, de la Cruz, AP, Rodríguez-Elvira, M, Planells, E
Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS). 2018;:202-209
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Abstract
INTRODUCTION Critically ill patients develop severe stress, inflammation and a clinical state that may raise the utilization and metabolic replacement of many nutrients and especially zinc, depleting their body reserves. This study was designed to assess the zinc status in critical care patients with systemic inflammatory response syndrome (SIRS), comparing them with a group of healthy people, and studying the association with expression of zinc transporters. MATERIAL AND METHODS This investigation was a prospective, multicentre, comparative, observational and analytic study. Twelve critically ill patients from different hospitals and 12 healthy subjects from Granada, Spain, all with informed consent were recruited. Data on daily nutritional assessment, ICU severity scores, inflammation, clinical and nutritional parameters, plasma and blood cell zinc concentrations, and levels of transcripts for zinc transporters in whole blood were taken at admission and at the seventh day of the ICU stay. RESULTS Zinc levels on critical ill patient are diminish comparing with the healthy control (HS: 0.94 ± 0.19; CIPF 0.67 ± 0.16 mg/dL). The 58% of critical ill patients showed zinc plasma deficiency at beginning of study while 50.0% of critical ill after 7 days of ICU stay. ZnT7, ZIP4 and ZIP9 were the zinc transporters with highest expression in whole blood. In general, all zinc transporters were significantly down-regulated (P < 0.05) in the critical ill population at admission in comparison with healthy subjects. Severity scores and inflammation were significantly associated (P < 0.05) with zinc plasma levels, and zinc transporters ZIP3, ZIP4, ZIP8, ZnT6, ZnT7. Expression of 11 out of 24 zinc transporters was analysed, and ZnT1, ZnT4, ZnT5 and ZIP4, which were downregulated by more than 3-fold in whole blood of patients. CONCLUSION In summary, in our study an alteration of zinc status was related with the severity-of-illness scores and inflammation in critical ill patients since admission in ICU stay. SIRS caused a general shut-down of expression of zinc transporters in whole blood. That behavior was associated with severity and inflammation of patients at ICU admission regardless zinc status. We conclude that zinc transporters in blood might be useful indicators of severity of systemic inflammation and outcome for critically ill patients.
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A Trial on The Effects of Magnesium-Zinc-Calcium-Vitamin D Co-Supplementation on Glycemic Control and Markers of Cardio-Metabolic Risk in Women with Polycystic Ovary Syndrome.
Jamilian, M, Maktabi, M, Asemi, Z
Archives of Iranian medicine. 2017;(10):640-645
Abstract
BACKGROUND There is scarce data on the effects of magnesium-zinc-calcium-vitamin D co-supplementation on glycemic control and markers of cardio-metabolic risk among women with polycystic ovary syndrome (PCOS). The objective of this study was to assess the effects of magnesium-zinc-calcium-vitamin D co-supplementation on glycemic control and markers of cardio-metabolic risk in women with PCOS. METHODS Sixty PCOS women were randomized into two groups and treated with 100 mg of magnesium, 4 mg of zinc, 400 mg of calcium plus 200 IU of vitamin D supplements (n = 30) or placebo (n = 30) twice a day for 12 weeks. Glycemic control and markers of cardio-metabolic risk were assessed at baseline and at the end of trial. RESULTS After the 12-week intervention, compared with the placebo, magnesium-zinc-calcium-vitamin D co-supplementation supplementation resulted in significant reductions in serum insulin levels (-1.9 ± 4.6 vs. +0.4 ± 2.8 µIU/mL, P = 0.01), and homeostatic model of assessment for insulin resistance (-0.4 ± 1.0 vs. +0.1 ± 0.6, P = 0.02), as well as a significant increase in quantitative insulin sensitivity check index (+0.01 ± 0.02 vs. -0.0003 ± 0.01, P = 0.02). In addition, magnesium-zinc-calcium-vitamin D co-supplementation significantly decreased serum triglycerides (-26.5 ± 42.9 vs. +8.9 ± 17.9 mg/dL, P < 0.001), VLDL-cholesterol concentrations (-5.3 ± 8.6 vs. +1.8 ± 3.6 mg/dL, P < 0.001), total cholesterol (-4.2 ± 30.7 vs. +11.1 ± 28.4 mg/dL, P = 0.04) and total-/HDL-cholesterol ratio (-0.04 ± 0.6 vs. +0.3 ± 0.9, P = 0.04) compared with the placebo. CONCLUSION Overall, the results of this study demonstrated that magnesium-zinc-calcium-vitamin D co-supplementation for 12 weeks among patients with PCOS had beneficial effects on insulin metabolism and markers of cardio-metabolic risk.
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Systematic review and meta-analysis shows a specific micronutrient profile in people with Down Syndrome: Lower blood calcium, selenium and zinc, higher red blood cell copper and zinc, and higher salivary calcium and sodium.
Saghazadeh, A, Mahmoudi, M, Dehghani Ashkezari, A, Oliaie Rezaie, N, Rezaei, N
PloS one. 2017;(4):e0175437
Abstract
Different metabolic profiles as well as comorbidities are common in people with Down Syndrome (DS). Therefore it is relevant to know whether micronutrient levels in people with DS are also different. This systematic review was designed to review the literature on micronutrient levels in people with DS compared to age and sex-matched controls without DS. We identified sixty nine studies from January 1967 to April 2016 through main electronic medical databases PubMed, Scopus, and Web of knowledge. We carried out meta-analysis of the data on four essential trace elements (Cu, Fe, Se, and Zn), six minerals (Ca, Cl, K, Mg, Na, and P), and five vitamins (vitamin A, B9, B12, D, and E). People with DS showed lower blood levels of Ca (standard mean difference (SMD) = -0.63; 95% confidence interval (CI): -1.16 to -0.09), Se (SMD = -0.99; 95% CI: -1.55 to -0.43), and Zn (SMD = -1.30; 95% CI: -1.75 to -0.84), while red cell levels of Zn (SMD = 1.88; 95% CI: 0.48 to 3.28) and Cu (SMD = 2.77; 95% CI: 1.96 to 3.57) were higher. They had also higher salivary levels of Ca (SMD = 0.85; 95% CI: 0.38 to 1.33) and Na (SMD = 1.04; 95% CI: 0.39 to 1.69). Our findings that micronutrient levels are different in people with DS raise the question whether these differences are related to the different metabolic profiles, the common comorbidities or merely reflect DS.
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Zinc supplementation improves anticancer activity of monocytes in type-2 diabetic patients with metabolic syndrome.
Meksawan, K, Sermsri, U, Chanvorachote, P
Anticancer research. 2014;(1):295-9
Abstract
BACKGROUND Transmembrane tumor necrosis factor (TNF)-α, found on monocytes, is a body's key defense against cancer. In patients with type 2 diabetes mellitus (DM) and metabolic syndrome, immunity is suppressed, resulting in a high risk of several inflammatory disorders and cancer. PATIENTS AND METHODS Seventeen patients with type 2 DM and metabolic syndrome were supplemented with either 30 mg of elemental zinc/day or placebo for eight weeks. Transmembrane TNF-α-expressing monocytes and lymphocytes, and plasma TNF-α levels were analyzed before and after supplementation. RESULTS The present study revealed that zinc supplementation significantly increased the proportion of monocytes expressing transmembrane TNF-α. While the plasma TNF-α levels and TNF-α expressing lymphocytes were not significantly altered in the zinc-treated and placebo groups, higher proportion of TNF-α bound monocytes were observed in the zinc-treated group. CONCLUSION Because functional transmembrane TNF-α was shown to be implicated in defense mechanisms, these findings suggest that zinc supplementation may benefit immune response against cancer in patients with DM and metabolic syndrome.
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Selenium, zinc, and copper plasma levels in patients with schizophrenia: relationship with metabolic risk factors.
Vidović, B, Dorđević, B, Milovanović, S, Škrivanj, S, Pavlović, Z, Stefanović, A, Kotur-Stevuljević, J
Biological trace element research. 2013;(1-3):22-8
Abstract
The aim of this study was to determine the plasma selenium (Se), copper (Cu), and zinc (Zn) levels and to evaluate their possible association with metabolic syndrome (MetS) components in patients with schizophrenia. The study group consisted of 60 patients with schizophrenia and 60 sex- and age-matched healthy controls. Anthropometric measurements, blood pressure, and biochemical analysis of fasting blood were performed in all subjects. Patients with schizophrenia had significantly higher plasma Cu concentrations compared with controls (0.97 ± 0.31 vs. 0.77 ± 0.32 mg/L, p = 0.001). The plasma Cu concentration showed a positive correlation with plasma glucose and diastolic blood pressure in the patient groups (r s = 0.263, p < 0.05 and r s = 0.272, p < 0.05, respectively). The plasma Se level correlated positive with MetS score (r s = 0.385, p < 0.01), waist circumference (r s = 0.344, p < 0.05), plasma glucose (r s = 0.319, p < 0.05), and triglyceride concentrations (r s = 0.462, p < 0.001) in patients with schizophrenia. Plasma Zn did not correlate with any of the MetS components. These results suggest that alterations in plasma Cu and Se levels in medicated patients with schizophrenia could be associated with metabolic risk factors.
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Short-term weight loss in overweight/obese low-income women improves plasma zinc and metabolic syndrome risk factors.
Voruganti, VS, Cai, G, Klohe, DM, Jordan, KC, Lane, MA, Freeland-Graves, JH
Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS). 2010;(4):271-6
Abstract
Metabolic syndrome is a group of disorders involving obesity, insulin resistance, dyslipidemia and hypertension. Obesity is the most crucial risk factor of metabolic syndrome, because it is known to precede other risk factors. Obesity is also associated with disturbances in the metabolism of the trace mineral, zinc. The overall purpose of this study was to investigate the effects of short-term weight loss on plasma zinc and metabolic syndrome risk factors. An 8-week weight loss intervention study was conducted with 90 low-income overweight/obese mothers, whose youngest child was 1-3 years old. Plasma levels of zinc, glucose, insulin, leptin, triglycerides, total, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol were measured and compared at weeks 0 and 8 of the weight loss program. At pre-study, plasma zinc was low in 39% and, within normal values in 46%, of obese/overweight mothers. By the end of intervention, plasma zinc rose by 22% and only 5% of the mothers continued to exhibit low plasma zinc. At post-study, the metabolic syndrome risk factors of waist circumference, HDL cholesterol, and diastolic blood pressure (p<0.05) showed significant improvements. Plasma zinc increased by a greater margin (67%) in women with low zinc, as compared to those with normal zinc (18%); weight reduction was similar in both the groups. Finally, changes in % body fat were related negatively with changes in plasma zinc (r=- 0.28, p<0.05). The circulating levels of zinc, as well as the metabolic syndrome components, showed significant improvements in overweight/obese low-income women after weight loss.
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Zinc supplementation for the prevention of type 2 diabetes mellitus.
Beletate, V, El Dib, RP, Atallah, AN
The Cochrane database of systematic reviews. 2007;(1):CD005525
Abstract
BACKGROUND The chronic hyperglycaemia of diabetes is associated with long-term damage, dysfunction, and failure of various organs, especially the eyes, kidneys, nerves, heart, and blood vessels. The risk of developing type 2 diabetes increases with age, obesity, and lack of physical activity. Insulin resistance is a fundamental aspect of the aetiology of type 2 diabetes. Insulin resistance has been shown to be associated with atherosclerosis, hypertriglyceridaemia, glucose intolerance, dyslipidaemia, hyperuricaemia, hypertension and polycystic ovary syndrome. The mineral zinc plays a key role in the synthesis and action of insulin, both physiologically and in diabetes mellitus. Zinc seems to stimulate insulin action and insulin receptor tyrosine kinase activity. OBJECTIVES To assess the effects of the zinc supplementation in the prevention of type 2 diabetes mellitus. SEARCH STRATEGY Studies were obtained from computerised searches of MEDLINE, EMBASE, LILACS and The Cochrane Library. SELECTION CRITERIA Studies were included if they had a randomised or quasi-randomised design and if they investigated zinc supplementation in adults living in the community, 18 years or older with insulin resistance (compared to placebo or no intervention). DATA COLLECTION AND ANALYSIS Two authors selected relevant trials, assessed methodological quality and extracted data. MAIN RESULTS Only one study met the inclusion criteria of this review. There were 56 normal glucose tolerant obese women (aged 25 to 45 years, body mass index 36.2 +/- 2.3 kg/m(2)). Follow-up was four weeks. The outcomes measured were decrease of insulin resistance, anthropometric and diet parameters, leptin and insulin concentration, zinc concentration in the plasma and urine, lipid metabolism and fasting plasma glucose. There were no statistically significant differences favouring participants receiving zinc supplementation compared to placebo concerning any outcome measured by the study. AUTHORS' CONCLUSIONS There is currently no evidence to suggest the use of zinc supplementation in the prevention of type 2 diabetes mellitus. Future trials will have to standardise outcomes measures such as incidence of type 2 diabetes mellitus, decrease of the insulin resistance, quality of life, diabetic complications, all-cause mortality and costs.