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Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons.
Barnes, LL, Dhana, K, Liu, X, Carey, VJ, Ventrelle, J, Johnson, K, Hollings, CS, Bishop, L, Laranjo, N, Stubbs, BJ, et al
The New England journal of medicine. 2023;389(7):602-611
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Lifestyle interventions targeting diet are a possible approach that could affect public health. Most clinical trials have investigated comprehensive diets, in contrast to dietary manipulation of single foods or nutrients. The aim of this study was to evaluate the effects of a 3-year dietary intervention on cognitive decline and brain-imaging markers of dementia and Alzheimer’s disease in older, cognitively unimpaired adults at risk for dementia because of family history. This study was a 3-year, two-site, randomised, controlled trial. The participants were randomly assigned to follow the MIND diet with mild caloric restriction for weight loss or their usual diet with the same mild caloric restriction for weight loss (control diet). Participants were randomly assigned in a 1:1 ratio. Results showed that the participants who followed the MIND diet had small improvements in a global measure of cognition that were similar to those who followed a control diet with mild caloric restriction. Authors concluded that brain health, cognitive function and brain imaging outcomes (after 3 years) did not differ significantly between participants who followed the MIND diet and those who followed a control diet with a mild caloric restriction.
Abstract
BACKGROUND Findings from observational studies suggest that dietary patterns may offer protective benefits against cognitive decline, but data from clinical trials are limited. The Mediterranean-DASH Intervention for Neurodegenerative Delay, known as the MIND diet, is a hybrid of the Mediterranean diet and the DASH (Dietary Approaches to Stop Hypertension) diet, with modifications to include foods that have been putatively associated with a decreased risk of dementia. METHODS We performed a two-site, randomized, controlled trial involving older adults without cognitive impairment but with a family history of dementia, a body-mass index (the weight in kilograms divided by the square of the height in meters) greater than 25, and a suboptimal diet, as determined by means of a 14-item questionnaire, to test the cognitive effects of the MIND diet with mild caloric restriction as compared with a control diet with mild caloric restriction. We assigned the participants in a 1:1 ratio to follow the intervention or the control diet for 3 years. All the participants received counseling regarding adherence to their assigned diet plus support to promote weight loss. The primary end point was the change from baseline in a global cognition score and four cognitive domain scores, all of which were derived from a 12-test battery. The raw scores from each test were converted to z scores, which were averaged across all tests to create the global cognition score and across component tests to create the four domain scores; higher scores indicate better cognitive performance. The secondary outcome was the change from baseline in magnetic resonance imaging (MRI)-derived measures of brain characteristics in a nonrandom sample of participants. RESULTS A total of 1929 persons underwent screening, and 604 were enrolled; 301 were assigned to the MIND-diet group and 303 to the control-diet group. The trial was completed by 93.4% of the participants. From baseline to year 3, improvements in global cognition scores were observed in both groups, with increases of 0.205 standardized units in the MIND-diet group and 0.170 standardized units in the control-diet group (mean difference, 0.035 standardized units; 95% confidence interval, -0.022 to 0.092; P = 0.23). Changes in white-matter hyperintensities, hippocampal volumes, and total gray- and white-matter volumes on MRI were similar in the two groups. CONCLUSIONS Among cognitively unimpaired participants with a family history of dementia, changes in cognition and brain MRI outcomes from baseline to year 3 did not differ significantly between those who followed the MIND diet and those who followed the control diet with mild caloric restriction. (Funded by the National Institute on Aging; ClinicalTrials.gov number, NCT02817074.).
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Comparative effectiveness of furosemide vs torasemide in symptomatic therapy in heart failure patients: A randomized controlled study protocol.
Li, Y, Li, L, Guo, Z, Zhang, S
Medicine. 2021;(7):e24661
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Abstract
BACKGROUND We performed this randomized controlled study protocol to investigate the efficacy and adverse effects of furosemide vs torasemide in patients with heart failure (HF). METHOD The present study was authorized by the local research ethics committee of Shanxi Cardiovascular Hospital (no. 48736645) and informed consent was obtained from all patients. Patients were enrolled in a consecutive prospective manner on a voluntary basis. Patients who were aged 18 years and older with HF who were eligible to enroll in this randomized trial. All patients had evidence of left ventricular systolic dysfunction, confirmed by echocardiographic or nuclear imaging. The exclusion criteria were left ventricular diastolic dysfunction only, or receipt of medical or pharmaceutical care in other health systems. The primary efficacy end point was the change in procollagen type I carboxyterminal peptide (PICP) serum levels between baseline and final visit. Secondary efficacy variables included parameters related to the clinical course of HF, such as body weight, presence of edema, signs and symptoms of HF, electrocardiogram and echocardiographic evaluation, amino-terminal pro brain-type natriuretic peptide (NT-proBNP) serum levels measured by ELISA method, systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, and renal function. RESULTS One hundred patients who met the inclusion criteria were included in our study, Table 1 showed the effects of furosemide and torsemide on measures of clinical outcomes. DISCUSSION Fluid overload is the primary cause of hospitalization among patients with HF. Preventing circulatory congestion requires careful control of dietary sodium and chronic administration of loop diuretics. Torasemide and furosemide are representatives of loop diuretics with an identical diuretic mechanism, but different pharmacokinetic properties and additional effects. There is a need for reliable conclusion regarding the comparison of furosemide and torasemide in patients with HF. Several limitation should be noted: 1. the small number of participants did not enable assessment of the impact of torasemide and furosemide in different clinically relevant subgroups that is, elderly, patients with chronic kidney disease, dilated cardiomyopathy; 2. short-term follow up might lead to underestimation of the complications; 3. methodological weakness in study design may affect the results. Future high quality studies were still required.
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Association of Newly Found Asymptomatic Intracranial Artery Stenosis and Ideal Cardiovascular Health Metrics in Chinese Community Population.
Fan, C, Zhang, Q, Zhang, S, Wang, A, Bi, X, Chen, S, Li, Z, Wu, S, Zhao, X
Scientific reports. 2020;(1):7200
Abstract
In the general population, there is a strong inverse relationship between the number of ideal cardiovascular health (CVH) metrics and the total incidence of cardiovascular diseases and stroke. However, the prevalence of ideal CVH is extremely low and there are few studies on its association with newly found asymptomatic intracranial arterial stenosis (AICAS). Therefore, we performed this prospective study to assess the relationship between the newly found AICAS and ideal CVH metrics in the Chinese community population. Seven ideal CVH metrics of 3,475 participants in the Asymptomatic Polyvascular Abnormalities Community study (APAC) conducted in China (1,962 men and 1,513 women between the ages of 45 and 75 years) were collected. Based on the occurrence of newly found AICAS, all participants were divided into the AICAS group and non-ICAS group. Prevalence of ideal CVH metrics was compared between the two groups. Logistic regression was used to estimate the association of newly found AICAS with ideal CVH metrics. The result was the number of ideal CVH metrics was strongly associated with age, gender, education levels and family income (each P < 0.0001). Among the seven CVH metrics total cholesterol (TC) was the only one showing significant difference between the newly found AICAS group and non-ICAS group in our 2 years observation. Participants with less ideal CVH metrics (≤3) were associated with significantly higher prevalence of AICAS than those with more (>3) ideal CVH metrics (OR, 1.27; P = 0.045). Furthermore, less (≤3) ideal CVH metrics was markedly associated with higher incidence of AICAS for all participants, younger participants (<60 years) (OR, 1.34; P = 0.046) and men participants (OR, 1.53; P = 0.032) after adjustment for gender, age, education level, family income and stroke history. Thus we conclude that participants with newly found AICAS have high prevalence of total cholesterol status, and Individuals with low ideal CVH metrics (≤3) are associated with significantly higher prevalence of asymptomatic ICAS, especially in high-risk population of young and men participants. Therefore, primordial prevention of stroke should also focus on those high-risk populations.
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Comparative genomics of Bacteria commonly identified in the built environment.
Merino, N, Zhang, S, Tomita, M, Suzuki, H
BMC genomics. 2019;(1):92
Abstract
BACKGROUND The microbial community of the built environment (BE) can impact the lives of people and has been studied for a variety of indoor, outdoor, underground, and extreme locations. Thus far, these microorganisms have mainly been investigated by culture-based methods or amplicon sequencing. However, both methods have limitations, complicating multi-study comparisons and limiting the knowledge gained regarding in-situ microbial lifestyles. A greater understanding of BE microorganisms can be achieved through basic information derived from the complete genome. Here, we investigate the level of diversity and genomic features (genome size, GC content, replication strand skew, and codon usage bias) from complete genomes of bacteria commonly identified in the BE, providing a first step towards understanding these bacterial lifestyles. RESULTS Here, we selected bacterial genera commonly identified in the BE (or "Common BE genomes") and compared them against other prokaryotic genera ("Other genomes"). The "Common BE genomes" were identified in various climates and in indoor, outdoor, underground, or extreme built environments. The diversity level of the 16S rRNA varied greatly between genera. The genome size, GC content and GC skew strength of the "Common BE genomes" were statistically larger than those of the "Other genomes" but were not practically significant. In contrast, the strength of selected codon usage bias (S value) was statistically higher with a large effect size in the "Common BE genomes" compared to the "Other genomes." CONCLUSION Of the four genomic features tested, the S value could play a more important role in understanding the lifestyles of bacteria living in the BE. This parameter could be indicative of bacterial growth rates, gene expression, and other factors, potentially affected by BE growth conditions (e.g., temperature, humidity, and nutrients). However, further experimental evidence, species-level BE studies, and classification by BE location is needed to define the relationship between genomic features and the lifestyles of BE bacteria more robustly.
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Comparisons of weight changes between sodium-glucose cotransporter 2 inhibitors treatment and glucagon-like peptide-1 analogs treatment in type 2 diabetes patients: A meta-analysis.
Cai, X, Ji, L, Chen, Y, Yang, W, Zhou, L, Han, X, Zhang, S, Ji, L
Journal of diabetes investigation. 2017;(4):510-517
Abstract
AIMS/INTRODUCTION To evaluate the efficacy of weight changes from baseline of the sodium-glucose cotransporter 2 (SGLT2) inhibitors treatment and glucagon-like peptide-1 (GLP-1) analogs treatment after comparisons with a placebo in type 2 diabetes patients, and the associated factors. MATERIALS AND METHODS Studies were searched from when recording began, June 2004, until June 2015, and re-searched in July 2016, and placebo-controlled randomized trials in type 2 diabetes patients with a study length of ≥12 weeks were included. RESULTS A total of 97 randomized controlled trials were included. Compared with a placebo, treatment with SGLT2 inhibitors was associated with a significantly greater decrease in weight change from baseline (weighted mean differences -2.01 kg, 95% confidence interval -2.18 to -1.83 kg, P < 0.001). Compared with a placebo, changes with GLP -1 treatment were also associated with a comparable decrease in weight change from baseline (weighted mean differences -1.59 kg, 95% confidence interval -1.86 to -1.32 kg, P < 0.001). Meta-regression analysis showed that the baseline age, sex, baseline glycated hemoglobin, diabetes duration or baseline body mass index were not associated with the weight change from baseline in SGLT2 inhibitors or in GLP-1 treatment corrected by placebo. Comparisons of weight changes from baseline corrected by placebo between SGLT2 inhibitors and GLP-1 treatment showed that the difference was not significant (P > 0.05). CONCLUSIONS According to the present meta-analysis, treatment with SGLT2 inhibitors and treatment with GLP-1 analogs led to comparable weight changes from baseline, which are both with significance when compared with placebo treatment.
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Clinical Outcomes for Systemic Corticosteroids Versus Vincristine in Treating Kaposiform Hemangioendothelioma and Tufted Angioma.
Liu, X, Li, J, Qu, X, Yan, W, Zhang, L, Zhang, S, Yang, C, Zheng, J
Medicine. 2016;(20):e3431
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A meta-analysis was performed to evaluate the efficacy and safety of systemic corticosteroids versus those of vincristine in the treatment of kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).A literature search of PubMed, Embase, and Web of Science was performed for clinical studies on systemic corticosteroid versus vincristine therapies in treating KHE/TA. Pooled relative risks (RRs) and response rate with 95% confidence intervals (CIs) were used to measure outcomes. Heterogeneity, subgroup analysis, sensitivity analysis, and publication bias analysis were performed for result evaluation.Thirteen studies, comprising 344 participants, were used in the analysis. Vincristine therapy was found to be relatively more effective than systemic corticosteroids (RRs = 0.45, 95%CI: 0.35-0.58). The result of pooled adverse reactions response rate for systemic corticosteroids was 0.31 (95%CI, 0.18-0.43), significantly higher than that for vincristine, which was 0.12 (95%CI, 0.06-0.19). In subgroup analyses, factors including mean age and race of patients, and period of follow-up were examined as possible sources of heterogeneity.This is the first meta-analysis estimating the clinical outcomes of systemic corticosteroids in comparison with those of vincristine in the treatment of KHE/TA. The results showed that vincristine was considerably more effective with lower complication rates than systemic corticosteroids; thus, vincristine could be suggested as the first-line therapy for KHE/TA.
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Protein Beverage vs. Protein Gel on Appetite Control and Subsequent Food Intake in Healthy Adults.
Zhang, S, Leidy, HJ, Vardhanabhuti, B
Nutrients. 2015;(10):8700-11
Abstract
The objective of this study was to compare the effects of food form and physicochemical properties of protein snacks on appetite and subsequent food intake in healthy adults. Twelve healthy subjects received a standardized breakfast and then 2.5 h post-breakfast consumed the following snacks, in randomized order: 0 kcal water (CON) or 96 kcal whey protein snacks as beverages with a pH of either 3.0 (Bev-3.0) or 7.0 (Bev-7.0) or gels as acid (Gel-Acid) or heated (Gel-Heated). In-vitro study showed that Bev-3.0 was more resistant to digestion than Bev-7.0, while Gel-Acid and Gel-Heated had similar digestion pattern. Appetite questionnaires were completed every 20 min until an ad libitum lunch was provided. Post-snack hunger, desire to eat, and prospective food consumption were lower following the beverages and gels vs. CON (all, p < 0.05), and post-snack fullness was greater following the snacks (except for the Bev-3.0) vs. CON (all, p < 0.05). Gel-Heated treatment led to lower prospective food consumption vs. Bev-3.0; however, no other differences were detected. Although all snacks reduced energy intake vs. CON, no differences were observed among treatments. This study suggested that whey protein in either liquid or solid form improves appetite, but the physicochemical property of protein has a minimal effect.
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Effect of egg ingestion on trimethylamine-N-oxide production in humans: a randomized, controlled, dose-response study.
Miller, CA, Corbin, KD, da Costa, KA, Zhang, S, Zhao, X, Galanko, JA, Blevins, T, Bennett, BJ, O'Connor, A, Zeisel, SH
The American journal of clinical nutrition. 2014;(3):778-86
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BACKGROUND It is important to understand whether eating eggs, which are a major source of dietary choline, results in increased exposure to trimethylamine-N-oxide (TMAO), which is purported to be a risk factor for developing heart disease. OBJECTIVE We determined whether humans eating eggs generate TMAO and, if so, whether there is an associated increase in a marker for inflammation [ie, high-sensitivity C-reactive protein (hsCRP)] or increased oxidation of low-density lipoprotein (LDL). DESIGN In a longitudinal, double-blind, randomized dietary intervention, 6 volunteers were fed breakfast doses of 0, 1, 2, 4, or 6 egg yolks. Diets were otherwise controlled on the day before and day of each egg dose with a standardized low-choline menu. Plasma TMAO at timed intervals (immediately before and 1, 2, 4, 8, and 24 h after each dose), 24-h urine TMAO, predose and 24-h postdose serum hsCRP, and plasma oxidized LDL were measured. Volunteers received all 5 doses with each dose separated by >2-wk washout periods. RESULTS The consumption of eggs was associated with increased plasma and urine TMAO concentrations (P < 0.01), with ∼14% of the total choline in eggs having been converted to TMAO. There was considerable variation between individuals in the TMAO response. There was no difference in hsCRP or oxidized LDL concentrations after egg doses. CONCLUSIONS The consumption of ≥2 eggs results in an increased formation of TMAO. Choline is an essential nutrient that is required for normal human liver and muscle functions and important for normal fetal development. Additional study is needed to both confirm the association between TMAO and atherosclerosis and identify factors, microbiota and genetic, that influence the generation of TMAO before policy and medical recommendations are made that suggest reduced dietary choline intake.
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The RADAR study: week 48 safety and efficacy of RAltegravir combined with boosted DARunavir compared to tenofovir/emtricitabine combined with boosted darunavir in antiretroviral-naive patients. Impact on bone health.
Bedimo, RJ, Drechsler, H, Jain, M, Cutrell, J, Zhang, S, Li, X, Farukhi, I, Castanon, R, Tebas, P, Maalouf, NM
PloS one. 2014;(8):e106221
Abstract
BACKGROUND NRTI-sparing regimens may avoid long-term mitochondrial, bone and renal toxicities and maintain viral suppression. METHODS In the RADAR study, 85 antiretroviral-naïve HIV-infected patients were randomized to receive either raltegravir (RAL) (n = 42) or tenofovir/emtricitabine (TDF/FTC) (n = 43), each with ritonavir-boosted darunavir (DRV/r). Virologic efficacy was assessed at weeks 24 and 48. Bone mineral density (BMD) was assessed by dual energy X-ray absorptiometry (DXA) scan at baseline and week 48, and bone turnover markers (BTM) assessed at weeks 0, 16 and 48. RESULTS Using an intention-to-treat analysis, 62.5% of RAL subjects and 83.7% of TDF/FTC subjects were responders (VL<48 copies/mL) at week 48 (p = 0.045; chi-square test). The proportions of patients achieving VL<200 copies/mL were similar: 72.5% and 86.0% (p = 0.175). Premature treatment discontinuation was the main cause for failure. No treatment-emergent resistance was observed. Changes from baseline in RAL vs. TDF/FTC for CD4+ (+199 vs. +216 cells/µL, p = 0.63), total cholesterol/HDL (-0.25 vs. -0.71 mg/dL (p = 0.270), and eGFR (-4.4 vs. -7.9 ml/min, p = 0.44) were comparable between groups. Changes in subtotal BMD to week 48 were: +9.2 with RAL vs. -7 g/cm2 with TDF/FTC (p = 0.002). Mean CTX changes were +0.04 vs. +0.24 ng/mL (p = 0.001), and mean P1NP changes were +3.59 vs. +30.09 ng/mL (p = 0.023). BTM changes at week 16 predicted change in BMD by week 48 (R = -0.394, p = 0.003 for CTX; and R = -0.477, p<0.001 for P1NP). CONCLUSION The NRTI-sparing regimen RAL+DRV/r did not achieve similar week 48 virologic efficacy compared with TDF/FTC+DRV/r, but was better with regard to markers of bone health. TRIAL REGISTRATION ClinicalTrials.gov NCT 00677300.
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Decreased conversion of 25-hydroxyvitamin D3 to 24,25-dihydroxyvitamin D3 following cholecalciferol therapy in patients with CKD.
Stubbs, JR, Zhang, S, Friedman, PA, Nolin, TD
Clinical journal of the American Society of Nephrology : CJASN. 2014;(11):1965-73
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BACKGROUND AND OBJECTIVES Elevated concentrations of fibroblast growth factor 23 (FGF23) are postulated to promote 25-hydroxyvitamin D (25[OH]D) insufficiency in CKD by stimulating 24-hydroxylation of this metabolite, leading to its subsequent degradation; however, prospective human studies testing this relationship are lacking. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS An open-label prospective study was conducted from October 2010 through July 2012 to compare the effect of 8 weeks of oral cholecalciferol therapy (50,000 IU twice weekly) on the production of 24,25(OH)2D3 in vitamin D-insufficient patients with CKD (n=15) and controls with normal kidney function (n=15). Vitamin D metabolites were comprehensively profiled at baseline and after treatment, along with FGF23 and other mineral metabolism parameters. RESULTS Vitamin D3 and 25(OH)D3 concentrations increased equivalently in the CKD and control groups following cholecalciferol treatment (median D3 change, 8.6 ng/ml [interquartile range, 3.9-25.6 ng/ml] for controls versus 12.6 ng/ml [6.9-41.2 ng/ml] for CKD [P=0.15]; 25(OH)D3 change, 39.2 ng/ml [30.9-47.2 ng/ml] for controls versus 39.9 ng/ml [31.5-44.1 ng/ml] for CKD [P=0.58]). Likewise, the absolute increase in 1α,25(OH)2D3 was similar between CKD participants and controls (change, 111.2 pg/ml [64.3-141.6 pg/ml] for controls versus 101.1 pg/ml [74.2-123.1 pg/ml] for CKD; P=0.38). Baseline and post-treatment 24,25(OH)2D3 concentrations were lower in the CKD group; moreover, the absolute increase in 24,25(OH)2D3 after therapy was markedly smaller in patients with CKD (change, 2.8 ng/ml [2.3-3.5 ng/ml] for controls versus 1.2 ng/ml [0.6-1.9 ng/ml] for patients with CKD; P<0.001). Furthermore, higher baseline FGF23 concentrations were associated with smaller increments in 24,25(OH)2D3 for individuals with CKD; this association was negated after adjustment for eGFR by multivariate analysis. CONCLUSIONS Patients with CKD exhibit an altered ability to increase serum 24,25(OH)2D3 after cholecalciferol therapy, suggesting decreased 24-hydroxylase activity in CKD. The observed relationship between baseline FGF23 and increments in 24,25(OH)2D3 further refutes the idea that FGF23 directly contributes to 25(OH)D insufficiency in CKD through stimulation of 24-hydroxylase activity.