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1.
A novel nutritional supplement containing amino acids and chromium decreases postprandial glucose response in a randomized, double-blind, placebo-controlled study.
Östman, E, Samigullin, A, Heyman-Lindén, L, Andersson, K, Björck, I, Öste, R, Humpert, PM
PloS one. 2020;(6):e0234237
Abstract
High postprandial blood glucose levels are associated with increased mortality, cardiovascular events and development of diabetes in the general population. Interventions targeting postprandial glucose have been shown to prevent both cardiovascular events and diabetes. This study evaluates the efficacy and safety of a novel nutritional supplement targeting postprandial glucose excursions in non-diabetic adults. Sixty overweight healthy male and female participants were recruited at two centers and randomized in a double-blind, placebo-controlled, crossover design. The supplement, a water-based drink containing 2.6g of amino acids (L-Leucine, L-Threonine, L-Lysine Monohydrochloride, L-Isoleucine, L-Valine) and 250 mcg of chromium picolinate, was consumed with a standardized carbohydrate-rich meal. The primary endpoint was the incremental area under the curve (iAUC) for venous blood glucose from 0 to 120 minutes. Secondary endpoints included glucose iAUC 0-180 minutes and the maximum glucose concentration (Cmax), for both venous and capillary blood glucose. In the intention-to-treat-analysis (n = 60) the supplement resulted in a decreased venous blood glucose iAUC0-120min compared to placebo, mean (SE) of 68.7 (6.6) versus 52.2 (6.8) respectively, a difference of -16.5 mmol/L•min (95% CI -3.1 to -30.0, p = 0.017). The Cmax for venous blood glucose for the supplement and placebo were 6.45 (0.12) versus 6.10 (<0.12), respectively, a difference of -0.35 mmol/L (95% CI -0.17 to -0.53, p<0.001). In the per protocol-analysis (n = 48), the supplement resulted in a decreased Cmax compared to placebo from 6.42 (0.14) to 6.12 (0.14), a difference of -0.29 mmol/L (95% CI -0.12 to -0.47, p = 0.002). No significant differences in capillary blood glucose were found, as measured by regular bed-side glucometers. The nutritional supplement drink containing amino acids and chromium improves the postprandial glucose homeostasis in overweight adults without diabetes. Future studies should clarify, whether regular consumption of the supplement improves markers of disease or could play a role in a diet aiming at preventing the development of diabetes.
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2.
Improving the endothelial dysfunction in type 2 diabetes with chromium and vitamin D3 byreducing homocysteine and oxidative stress: A randomized placebo-controlled trial.
Imanparast, F, Mashayekhi, FJ, Kamankesh, F, Rafiei, F, Mohaghegh, P, Alimoradian, A
Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS). 2020;:126639
Abstract
BACKGROUND Chromium picolinate (CrPic) and vitamin D3 are known as two antioxidant micronutrients. Through inducing endothelial dysfunction, oxidants such as homocysteine (Hct) and malondialdehyde (MDA) lead to cardiovascular disease in type 2 diabetes mellitus (T2DM). No published data has directly examined the effects of these two antioxidants on improving the endothelial dysfunction in T2DM throughreducing homocysteine and oxidative stress. METHODS Subjects (n = 92) in this randomized, double blind, placebo-control study were randomly assigned to receive oral placebo (group I), D3 (group II: 50,000 IU/ week), chromium picolinate (CrPic) (group III: 500 μg/day), and both vitamin D3 and CrPic (group IV) for four months. Fasting blood samples were drawn at study baseline and following intervention to determine Hct, MDA, total antioxidant capacity (TAC), total thiol groups (SHs), vascular cell adhesion molecule- 1 (VCAM-1), and plasminogen activator inhibitor-1 (PAI-1). RESULTS After intervention, MDA significantly decreased in groups II and IV; TAC significantly increased in group IV, and SHs significantly augmented in group III; Hct was significantly reduced in groups II, III, and IV; and VCAM-1 significantly decreased in groups III and IV and PAI-1 was significantly reduced in groups II, III, and IV. CONCLUSION Our findings suggest that through reducing homocysteine and oxidative stress and improving endothelial dysfunction, chromium and vitamin D3 co-supplementation might be predictive and preventive of cardiovascular diseasesassociated with T2DM. IRCT, IRCT20190610043852N1, registered 21 October 2019, https://fa.irct.ir/user/trial/42293/view.
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3.
Chromium Exposure and Risk of Cardiovascular Disease in High Cardiovascular Risk Subjects - Nested Case-Control Study in the Prevention With Mediterranean Diet (PREDIMED) Study.
Gutiérrez-Bedmar, M, Martínez-González, MÁ, Muñoz-Bravo, C, Ruiz-Canela, M, Mariscal, A, Salas-Salvadó, J, Estruch, R, Corella, D, Arós, F, Fito, M, et al
Circulation journal : official journal of the Japanese Circulation Society. 2017;(8):1183-1190
Abstract
BACKGROUND Epidemiological data on chromium (Cr) exposure and the risk of cardiovascular disease (CVD) are still limited. Toenail Cr level (TCL) provides a time-integrated measure reflecting long-term Cr exposure. We measured TCL to assess the hypothesis that long-term Cr exposure was inversely associated with incident CVD in a population at high risk for CVD.Methods and Results:The associations between TCL and CVD were evaluated in a case-control study nested within the "PREvención con DIeta MEDiterránea" (PREDIMED) trial. We randomly selected 147 of the 288 patients diagnosed with CVD during follow-up and matched them on age and sex to 271 controls. Instrumental neutron activation analysis was used to assess TCL. In-person interviews, medical record reviews, and validated questionnaires were used to assess covariates. The fully adjusted OR for the highest vs. lowest quartile of toenail Cr was 0.54 (95% CI: 0.26-1.14; Ptrend=0.189) for the nested case-control study. On stratification for diabetes mellitus (DM), OR was 1.37 (95% CI: 0.54-3.46; Ptrend=0.364) for the DM group, and 0.25 (95% CI: 0.08-0.80; Ptrend=0.030) for the non-DM group (P for interaction=0.078). CONCLUSIONS The present findings, although not statistically significant, are consistent with previously reported inverse associations between TCL and CVD. These results, especially for non-DM patients, increase the limited epidemiological knowledge about the possible protective role of Cr against CVD. (Trial registration: www.controlled-trials.com; ISRCTN35739639.).
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A cross-sectional study measuring vanadium and chromium levels in paediatric patients with CKD.
Filler, G, Kobrzynski, M, Sidhu, HK, Belostotsky, V, Huang, SS, McIntyre, C, Yang, L
BMJ open. 2017;(5):e014821
Abstract
OBJECTIVES Although many secondary effects of high levels of vanadium (V) and chromium (Cr) overlap with symptoms seen in paediatric patients with chronic kidney disease (CKD), their plasma V and Cr levels are understudied. DESIGN Ancillary cross-sectional study to a prospective, longitudinal, randomised controlled trial. SETTING Children's Hospital of Western Ontario, London Health Sciences Centre, London, Ontario, Canada. PARTICIPANTS 36 children and adolescents 4-18 years of age with CKD. INTERVENTIONS 1-6 trace element measurements per patient. Cystatin C (CysC) estimated glomerular filtration rate (eGFR) was calculated using the Filler formula. Plasma V and Cr levels were measured using high-resolution sector field inductively coupled mass spectrometry. Anthropomorphic data and blood parameters were collected from our electronic chart programme. Water Cr and V data were obtained from the Ontario Water (Stream) Quality Monitoring Network. PRIMARY AND SECONDARY OUTCOME MEASURES Primary outcomes: plasma Cr and V. SECONDARY OUTCOMES age, season, CysC, CysC eGFR, and Cr and V levels in environmental water. RESULTS The median (IQR) eGFR was 51 mL/min/1.73 m2 (35, 75). The median V level was 0.12 µg/L (0.09, 0.18), which was significantly greater than the 97.5th percentile of the reference interval of 0.088 µg/L; 32 patients had at least one set of V levels above the published reference interval. The median Cr level was 0.43 µg/L (0.36, 0.54), which was also significantly greater than the established reference interval; 34 had at least one set of Cr levels above the published reference interval. V and Cr levels were moderately correlated. Only some patients had high environmental exposure. CONCLUSIONS Our study suggests that paediatric patients with CKD have elevated plasma levels of V and Cr. This may be the result of both environmental exposure and a low eGFR. It may be necessary to monitor V and Cr levels in patients with an eGFR <30 mL/min/1.73 m2. TRIAL REGISTRATION NUMBER NCT02126293; HC#172241.
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Outcomes of patients treated with durable polymer platinum-chromium everolimus-eluting stents: a meta-analysis of randomised trials.
Cassese, S, Ndrepepa, G, Byrne, RA, Kufner, S, Xhepa, E, de Waha, A, Rheude, T, Colleran, R, Giacoppo, D, Harada, Y, et al
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2017;(8):986-993
Abstract
AIMS: The durable polymer platinum-chromium everolimus-eluting stent (PtCr-EES) is a new-generation drug-eluting stent (DES) with a platinum-enriched metallic platform developed to improve the percutaneous treatment of patients with coronary artery disease. We sought to investigate the performance of durable polymer PtCr-EES versus other new-generation DES. METHODS AND RESULTS We undertook a meta-analysis of trials in which patients receiving percutaneous coronary intervention (PCI) were randomly assigned to durable polymer PtCr-EES versus other new-generation DES (other DES). Primary efficacy and safety outcomes were target lesion revascularisation (TLR) and definite/probable stent thrombosis (ST), respectively. Secondary outcomes were myocardial infarction (MI), target vessel revascularisation (TVR), death, cardiac death and longitudinal stent deformation (LSD). A total of 11,036 patients in seven trials received a PCI with either durable polymer PtCr-EES (n=6,613) or other DES (n=4,423). This latter group comprised patients treated with biolimus- (n=325), cobalt-chromium everolimus- (n=1,940) or zotarolimus-eluting stents (n=2,158). After a median follow-up of 12 months (interquartile range 12-24), durable polymer PtCr-EES displayed a risk of TLR (odds ratio 0.98, 95% confidence interval [CI]: 0.75-1.29; p=0.90) and definite/probable ST (0.89 [0.55-1.45]; p=0.63) comparable to that of other DES. However, the durable polymer PtCr-EES was associated with a higher risk of LSD (12.05 [1.60-90.71], p=0.02) compared to other DES. There was no significant difference with regard to other secondary outcomes nor was there heterogeneity across trials. CONCLUSIONS At one-year follow-up, the durable polymer PtCr-EES displays a performance comparable to that of other new-generation DES platforms.
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The effect of a cinnamon-, chromium- and magnesium-formulated honey on glycaemic control, weight loss and lipid parameters in type 2 diabetes: an open-label cross-over randomised controlled trial.
Whitfield, P, Parry-Strong, A, Walsh, E, Weatherall, M, Krebs, JD
European journal of nutrition. 2016;(3):1123-31
Abstract
PURPOSE This randomised controlled trial assessed the acute and long-term effects of daily supplementation of kanuka honey, formulated with cinnamon, chromium and magnesium on glucose metabolism, weight and lipid parameters in individuals with type 2 diabetes. METHODS Twelve individuals with type 2 diabetes received 53.5 g of a formulated honey and a control (non-formulated) kanuka honey in a random order for 40 days, using cross-over design. Fasting glucose, insulin, HbA1c, lipids and anthropometric measures were measured at baseline and end of treatment. A meal tolerance test was performed at baseline to assess acute metabolic response. RESULTS There was no statistically significant difference in acute glucose metabolism between treatment groups, as measured by the Matsuda index and AUC for glucose and insulin. After the 40-day intervention with honey, fasting glucose did not differ significantly between the two treatments (95 % CI -2.6 to 0.07). There was no statistically significant change in HbA1c or fasting insulin. There was a statistically significant reduction in total cholesterol by -0.29 mmol/L (95 % CI -0.57 to -0.23), LDL cholesterol by -0.29 mmol/L (95 % CI -0.57 to -0.23) and weight by -2.2 kg (95 % CI -4.2 to -0.1). There was a trend towards increased HDL and reduced systolic blood pressure in the intervention treatment. CONCLUSION The addition of cinnamon, chromium and magnesium supplementation to kanuka honey was not associated with a significant improvement in glucose metabolism or glycaemic control in individuals with type 2 diabetes. Use of the formulated honey was associated with a reduction in weight and improvements in lipid parameters, and should be investigated further.
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Metal ion levels and functional results following resurfacing hip arthroplasty versus conventional small-diameter metal-on-metal total hip arthroplasty; a 3 to 5year follow-up of a randomized controlled trial.
Bisseling, P, Smolders, JM, Hol, A, van Susante, JL
The Journal of arthroplasty. 2015;(1):61-7
Abstract
We present an update of a randomized controlled trial on 71 patients (<65 years) who received either a resurfacing hip arthroplasty (RHA) (n=38) or cementless 28-mm metal-on-metal (MoM) total hip arthroplasty (THA) (n=33). Metal ion levels and functional outcome scores were analyzed with a mean follow-up of 58 months (SD 8.1). No clear shifts in relatively good outcome was encountered between RHA and THA. Metal ion levels appear to equalize between groups after 3 years. Median cobalt and chromium remained below 1.3 μg/L throughout follow-up in both groups. Six revisions were performed, of which three for pseudotumor formation (one THA, two RHA). In conclusion there were no clinical differences between the two groups and metal ion levels were lower than other series remained low, however, pseudotumor formation was not eliminated.
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A Dietary Supplement Containing Cinnamon, Chromium and Carnosine Decreases Fasting Plasma Glucose and Increases Lean Mass in Overweight or Obese Pre-Diabetic Subjects: A Randomized, Placebo-Controlled Trial.
Liu, Y, Cotillard, A, Vatier, C, Bastard, JP, Fellahi, S, Stévant, M, Allatif, O, Langlois, C, Bieuvelet, S, Brochot, A, et al
PloS one. 2015;(9):e0138646
Abstract
BACKGROUND Preventing or slowing the progression of prediabetes to diabetes is a major therapeutic issue. OBJECTIVES Our aim was to evaluate the effects of 4-month treatment with a dietary supplement containing cinnamon, chromium and carnosine in moderately obese or overweight pre-diabetic subjects, the primary outcome being change in fasting plasma glucose (FPG) level. Other parameters of plasma glucose homeostasis, lipid profile, adiposity and inflammatory markers were also assessed. METHODS In a randomized, double-blind, placebo-controlled study, 62 subjects with a FPG level ranging from 5.55 to 7 mmol/L and a body mass index ≥ 25 kg/m(2), unwilling to change their dietary and physical activity habits, were allocated to receive a 4-month treatment with either 1.2 g/day of the dietary supplement or placebo. Patients were followed up until 6 months post-randomization. RESULTS Four-month treatment with the dietary supplement decreased FPG compared to placebo (-0.24 ± 0.50 vs +0.12 ± 0.59 mmol/L, respectively, p = 0.02), without detectable significant changes in HbA1c. Insulin sensitivity markers, plasma insulin, plasma lipids and inflammatory markers did not differ between the treatment groups. Although there were no significant differences in changes in body weight and energy or macronutrient intakes between the two groups, fat-free mass (%) increased with the dietary supplement compared to placebo (p = 0.02). Subjects with a higher FPG level and a milder inflammatory state at baseline benefited most from the dietary supplement. CONCLUSIONS Four-month treatment with a dietary supplement containing cinnamon, chromium and carnosine decreased FPG and increased fat-free mass in overweight or obese pre-diabetic subjects. These beneficial effects might open up new avenues in the prevention of diabetes. TRIAL REGISTRATION ClinicalTrials.gov NCT01530685.
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Metal ion levels after metal-on-metal total hip arthroplasty: a five-year, prospective randomized trial.
Engh, CA, MacDonald, SJ, Sritulanondha, S, Korczak, A, Naudie, D, Engh, C
The Journal of bone and joint surgery. American volume. 2014;(6):448-55
Abstract
BACKGROUND The U.S. Food and Drug Administration has requested post-market surveillance data, including data on metal ion levels, regarding metal-on-metal total hip arthroplasty. We performed a prospective, randomized study of metal ion levels in erythrocytes, serum, and whole blood at five years after 28 and 36-mm metal-on-metal and 28-mm metal-on-polyethylene total hip arthroplasty. METHODS One hundred and five enrolled patients were randomized equally to the three bearing surface options and were blinded with regard to their treatment group. Metal ion measurements and clinical evaluations were performed at regular intervals. RESULTS Cobalt and chromium ion levels in all blood sample types at the five-year time point were significantly lower in the metal-on-polyethylene group than in each of the two metal-on-metal groups (p < 0.001) with the exception of chromium in erythrocytes (p = 0.194). Cobalt in serum (p = 0.029) and erythrocytes (p = 0.002) showed significant increases from two to five years in the 36-mm metal-on-metal group; similar increases were not seen in the 28-mm metal-on-metal group. At five years, five patients in the 36-mm metal-on-metal group and none in the 28-mm metal-on-metal group had cobalt or chromium levels of >7 ppb. Correlations among levels in serum, erythrocyte, and whole blood were stronger for cobalt than for chromium. One patient in the 36-mm metal-on-metal group underwent revision because of an adverse local tissue reaction. CONCLUSIONS The 36-mm metal-on-metal bearing underperformed the 28-mm metal-on-metal bearing with respect to metal ion levels. The authors are closely following all patients treated with metal-on-metal total hip arthroplasty.
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Metal ion trend may be more predictive for malfunctioning metal-on-metal implants than a single measurement.
Smolders, JM, Hol, A, van Susante, JL
Hip international : the journal of clinical and experimental research on hip pathology and therapy. 2013;(5):434-40
Abstract
Forty-eight unilateral hip resurfacing arthroplasty patients were evaluated for cobalt and chromium levels. The metal ion trend of 42 well-functioning patients was compared with six sub-optimal functioning patients. Median metal ion levels were significantly higher for the sub-optimal group. For the well-functioning implants, the percentage of patients with increasing cobalt/chromium levels between two consecutive time-intervals ('risers') gradually decreased from 90/86% (0-3 months) to 22/22% (24-36 months). The percentage of patients with increasing metal ion levels was higher in the sub-optimal group. The median absolute increase of this 'risers' subgroup was significantly lower for the well-functioning group at 12-24 months. Sub-optimal functioning MoM implants have a different metal ion trend than well-functioning implants, a higher chance of 'risers' and a larger absolute increase in time.