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Reliability of resting energy expenditure in major burns: Comparison between measured and predictive equations.
Jeon, J, Kym, D, Cho, YS, Kim, Y, Yoon, J, Yim, H, Hur, J, Chun, W
Clinical nutrition (Edinburgh, Scotland). 2019;(6):2763-2769
Abstract
BACKGROUND & AIMS Poor outcomes can result from inadequate energy intake. We aimed to investigate the reliability of resting energy expenditure (REE) measured by indirect calorimetry (IC) with REE calculated using predictive equations for nutritional support in patients with major burns. METHODS REE was measured using IC and compared with predictive equations in 215 adult severe burns patients from Jan 2011 to Jun 2015. Agreement between IC and predictive equations was assessed using Bland-Altman methods. RESULTS All predictive equations, including newly developed Hangang equation, were compared with REE measured using IC. The mean measured REE was 1712 kcal/d. Bland-Altman analysis showed that 1.2 times HBE, Thumb 25, and Ireton-Jones equations had higher accuracy and reliability. The concordance correlation coefficient was higher (0.49) in the Ireton-Jones equation, and root mean square error (RMSE) was lowest (471.5) in the Thumb 25 equation. The proportion of patients with predicted REE within ±10% of measured REE was highest with Thumb 25 (52.5%). In the validation set, the Hangang equation showed the highest Lin's concordance correlation coefficient (0.67) and the lowest RMSE (311.4). Other equations for burns patients had higher mean bias and overestimated REE when compared with IC results. CONCLUSIONS This study suggests that Thumb 25 can be used as an alternative method for estimating energy requirements of patients with major burns when IC is not available or applicable. However, for these patients with significant variation in metabolism over time, an alternative equation is the new Hangang equation.
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Impact of l-citrulline supplementation on oxygen uptake kinetics during walking.
Ashley, J, Kim, Y, Gonzales, JU
Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme. 2018;(6):631-637
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Abstract
Supplementation with l-citrulline (Cit) has been shown to improve muscle oxygenation and oxygen uptake kinetics during moderate- to high-intensity cycling in young men. The aim of this study was to test the hypothesis that Cit would improve oxygen uptake kinetics during walking in older and young adults. In a randomized, double-blind study, 26 (15 women, 11 men) adults between the ages of 20-35 years (n = 15) and 64-86 years (n = 11) completed 7-day periods of taking placebo and Cit (6 g/day) in a crossover manner. Participants walked on a treadmill at 40% heart rate reserve while pulmonary oxygen uptake was measured using indirect calorimetry. Net oxygen cost, mean response time (MRT), and the oxygen deficit were calculated before and after each supplement period. There was no significant change (P > 0.05) in net oxygen cost, MRT, or the oxygen deficit after Cit in older adults, while young adults showed a decrease (P = 0.05) in the oxygen deficit after Cit that tended (P = 0.053) to be different than the change after placebo. Sex-stratified analysis revealed that Cit decreased MRT (P = 0.04, Cohen's d = 0.41) and the oxygen deficit (P < 0.01, Cohen's d = 0.56) in men with the change after Cit being greater than the change after placebo (MRT: -4.5 ± 2.1 vs. 3.4 ± 2.1 s, P = 0.01; deficit: -0.15 ± 0.05 vs. 0.01 ± 0.05 L, P = 0.02). All oxygen uptake parameters were unchanged (P > 0.05) following Cit and placebo in women. Cit does not alter the oxygen cost of moderate-intensity walking in young or older adults, but Cit improved the rate of rise in oxygen uptake at exercise onset in men.
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Does l-citrulline supplementation improve exercise blood flow in older adults?
Gonzales, JU, Raymond, A, Ashley, J, Kim, Y
Experimental physiology. 2017;(12):1661-1671
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Abstract
What is the central question of this study? Does short-term supplementation with l-citrulline in order to increase l-arginine improve exercise blood flow and peripheral dilatation responses to exercise in older adults? What is the main finding and its importance? l-Citrulline increased femoral blood flow by 11% and vascular conductance by 14% during lower-limb exercise in older men, whereas no changes were observed in older women. This modest improvement in bulk muscle blood flow in older men has implications for altering muscle metabolism that may result in enhanced exercise tolerance in older adults. l-Citrulline (Cit) increases l-arginine (Arg), the primary substrate for nitric oxide biosynthesis. We tested the hypothesis that muscle blood flow during exercise would be enhanced by Cit supplementation in older adults. Femoral artery blood flow was measured during calf exercise using Doppler ultrasound, and vascular conductance (FVC) was calculated in 25 older adults (13 women and 12 men) before and after 14 days of Cit (6 g day-1 ) and placebo (maltodextrin) in a randomized, double-blind, crossover study. Plasma [Arg] and resting blood pressure were also measured before and after each condition. Women and men were analysed separately because of significant sex-by-condition interactions for the change in exercise blood flow and FVC. Plasma [Arg] was increased by 30 and 35% after Cit (P < 0.01) in women and men, respectively, with no change after placebo. Citrulline lowered diastolic blood pressure in men (75 ± 9 versus 71 ± 6 mmHg, P = 0.02), but this variable remained unchanged in women. Blood flow and FVC during exercise at higher workloads were increased after Cit in men (flow, 521 ± 134 versus 584 ± 166 ml min-1 , P = 0.04; FVC, 5.0 ± 1.5 versus 5.8 ± 1.7 m, min mmHg-1 , P = 0.01) but were not different after placebo. These variables were not altered by Cit in women. Adjusting for baseline diastolic blood pressure removed (P = 0.10) the difference in FBF and FVC following Cit in men. These results indicate that l-citrulline has a modest effect of improving muscle blood flow during submaximal exercise in older men.
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Effects of Two Different Dietary Patterns on Inflammatory Markers, Advanced Glycation End Products and Lipids in Subjects without Type 2 Diabetes: A Randomised Crossover Study.
Kim, Y, Keogh, JB, Clifton, PM
Nutrients. 2017;(4)
Abstract
Epidemiological studies suggest that consumption of red and processed meat and refined grains are associated with type 2 diabetes and metabolic syndrome and increased inflammatory and fibrinolytic markers. We hypothesised that a diet high in red and processed meat and refined grains (HMD) would increase inflammatory markers and advanced glycation end products (AGEs) compared with a diet high in dairy, whole grains, nuts and legumes (HWD). We performed a randomised crossover study of two four-week interventions in 51 participants without type 2 diabetes (15 men and 36 women aged 35.1 ± 15.6 years; body mass index: 27.7 ± 6.9 kg/m²). No baseline measurements were performed. Plasma fluorescent AGEs, carboxymethyllysine, glucose, insulin, lipids, hs-CRP, interleukin 6 (IL-6) and plasminogen activator inhibitor-1 (PAI-1) were analysed after four weeks on each diet. IL-6, hs-CRP, AGEs and carboxymethyllysine were not different between diets but PAI-1 was higher after the HMD than after HWD ((median and interquartile range) 158, 81 vs. 121, 53 ng/mL p < 0.001). PAI-1 on the HWD diet was inversely correlated with whole grains intake (p = 0.007). PAI-1 was inversely correlated with insulin sensitivity index (r = -0.45; p = 0.001) and positively correlated with serum total cholesterol (r = 0.35; p = 0.012) and serum triglyceride (r = 0.32; p = 0.021) on HMD. This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000519651).
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A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade(®)) in Healthy Subjects.
Shin, D, Kim, Y, Kim, YS, Körnicke, T, Fuhr, R
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy. 2015;(6):381-8
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OBJECTIVE SB2, a biosimilar to infliximab reference product (INF), has an identical amino acid sequence and similar physicochemical functional properties to its reference product. The primary objective of this study is to demonstrate pharmacokinetic (PK) bioequivalence between SB2 and EU-sourced INF (EU-INF), between SB2 and US-sourced INF (US-INF), and between EU-INF and US-INF. METHODS This study was a randomized, single-blind, three-arm, parallel group study in 159 healthy subjects. All subjects received a single 5 mg/kg intravenous infusion of study drug and then were observed for 10 weeks to study PK, safety and immunogenicity. The primary PK parameters were area under the concentration-time curve (AUC) from time zero to infinity (AUCinf), AUC from time zero to the last quantifiable concentration (AUClast) and maximum concentration (C max). Bioequivalence for the primary PK parameters was to be concluded using an analysis of variance (ANOVA) if the 90 % confidence intervals (CIs) for the ratio of geometric least squares means (LSMeans) of the treatments compared were completely contained within the pre-defined equivalence margin, 0.8-1.25. RESULTS All of the 90 % CIs for the geometric LSMean ratios of primary PK parameters for each comparison were within the pre-defined equivalence margin. The proportion of subjects who experienced treatment-emergent adverse events was comparable between treatments. The incidences of anti-drug antibodies between the three treatments were comparable. CONCLUSION This study demonstrated biosimilarity of SB2 to its marketed reference products of infliximab in terms of PK equivalence in healthy subjects. SB2 was generally well tolerated and showed comparable safety and immunogenicity profiles to the reference products (ClinicalTrials.gov Identifier: NCT01922336).
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Comparison of the effects of water- and land-based exercises on the physical function and quality of life in community-dwelling elderly people with history of falling: a single-blind, randomized controlled trial.
Oh, S, Lim, JM, Kim, Y, Kim, M, Song, W, Yoon, B
Archives of gerontology and geriatrics. 2015;(2):288-93
Abstract
PURPOSE The purpose of this study was to identify the effects of water-based exercises on the physical functions and quality of life (QOL) in community-dwelling elderly people with history of falling. MATERIALS AND METHODS Participants were randomly assigned to the water-based exercise group (n=34) or land-based exercise groups (n=32). To identify the effects on physical functions, muscle strength, flexibility, and mobility were measured. QOL and fear of falling were evaluated using the Short Form 36-item questionnaire and the modified falls efficacy scale (M-FES). The measurements were performed before and after the 10-week training period. RESULTS Within-group analysis indicated that hip abduction and adduction strength improved significantly in both groups (p=0.005; p=0.007). However, no statistically significant within-group differences were found in the back scratch test (p=0.766) and chair sit-and-reach test (p=0.870). QOL was significantly different in both groups (health transition: p=0.014, physical functioning: p<0.001, role physical: p<0.001, role emotional: p=0.002, bodily pain: p<0.001, vitality: p<0.001, and mental health: p<0.001). There was a significant difference in the M-FES in both groups (p=0.040). CONCLUSIONS These results indicate that water-based exercises are beneficial to improve the QOL, as well as physical activities, of community-dwelling elderly compared with land-based exercise. Water-based exercises would be useful to improve physical and psychological health in the elderly people with history of falling.
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Pharmacokinetic properties of isosorbide-5-mononitrate under fasting and fed conditions in healthy male subjects.
Jin, C, Jeon, JY, Im, YJ, Jeong, JA, Kim, Y, Chae, SW, Bentz, J, Kumke, T, Kim, MG
International journal of clinical pharmacology and therapeutics. 2015;(1):97-106
Abstract
OBJECTIVE This study was performed to compare the pharmacokinetic properties and relative bioavailability of two isosorbide-5-mononitrate (5-ISMN) sustained-release drugs in healthy Korean subjects under fasting and fed conditions. METHODS A total of 60 healthy volunteers (30 each in the fasting and fed arms of the study) were enrolled in the study and were randomized to treatment. After the administration of a single dose of one of the investigational products, blood samples were collected at specific time intervals from 0 to 36 hours. The plasma concentrations of 5-ISMN were measured by LC-MS/MS. The pharmacokinetic parameters were calculated, and the 90% confidence intervals (CIs) of the geometric mean ratio (test/reference) of the parameters were obtained by analysis of variance on logarithmically transformed data. RESULTS The corresponding 90% CIs of AUClast and Cmax for the test/reference geometric mean ratio were 90.75 - 98.44% and 92.28 - 98.33%, respectively, under fasting conditions. In the fed state study, the 90% CIs for the geometric mean ratio of test to reference drugs were 94.79 - 103.33% for AUClast and 99.86 - 108.02% for Cmax. CONCLUSION The test product is equivalent to the reference product in subjects under fasting and fed conditions within the Korean regulatory bioequivalence criteria. Both formulations were safe and well tolerated, and there were no noteworthy differences in the safety profiles between the test and reference drugs.
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Motor function in adults of an Ohio community with environmental manganese exposure.
Kim, Y, Bowler, RM, Abdelouahab, N, Harris, M, Gocheva, V, Roels, HA
Neurotoxicology. 2011;(5):606-14
Abstract
OBJECTIVES The objective of the present study was to evaluate motor function in order to assess the effects of long-term, low-level environmental manganese (Mn) exposure in residents of an Ohio community where a large ferro- and silico-Mn smelter has been active for more than 50 years. METHODS One hundred residents from the Mn-exposed Ohio community were evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS), a postural sway test, and a comprehensive questionnaire exploring demographics and general health. The results were compared to those of 90 residents from a demographically similar comparison town in Ohio. Mn exposure was assessed using modeled airborne Mn and blood Mn (Mn-B). The UPDRS was employed to evaluate parkinsonian motor features. Postural sway was measured using a CATSYS 2000 (Danish Product Development). RESULTS No significant difference between the exposed and comparison groups was evident as to Mn-B, demographics or major health outcomes. The risk of abnormal UPDRS performance using "Motor and Bradykinesia" criteria was increased in the Mn-exposed group after adjustment for potential confounders such as the presence of other neurotoxic metals, factors affecting susceptibility to Mn, potential factors influencing motor performance, and other possible demographic confounders. No participant was diagnosed with clinical manganism by neurological examination. After adjustment for various potential confounders, the Mn-exposed group showed significantly higher postural sway scores under eyes-open conditions than the comparison group. CONCLUSIONS Subclinical findings on the UPDRS and postural sway in the Mn-exposed group may possibly reflect early subtle effects of chronic low-level Mn exposure. However, the cross-sectional study design, the small to medium effect sizes, and the little biological plausibility are limiting the possibility of a causal relationship between the environmental Mn-air exposure and the early subclinical neurotoxic effects observed.
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PREFER study: a randomized clinical trial testing treatment preference and two dietary options in behavioral weight management--rationale, design and baseline characteristics.
Burke, LE, Choo, J, Music, E, Warziski, M, Styn, MA, Kim, Y, Sevick, MA
Contemporary clinical trials. 2006;(1):34-48
Abstract
BACKGROUND Obesity, a disorder associated with a myriad of comorbidities, is increasing at an alarming rate around the world. Given that pharmacotherapy has limited available options and that bariatric surgery is reserved for those who are morbidly obese or who have significant comorbidities, the most common approach to the treatment of obesity is standard behavioral treatment. This approach includes behavior modification related to eating and activity habits. The purpose of this paper is to describe the rationale, design, methods and baseline sample characteristics of a randomized controlled trial of a behavioral intervention in weight loss management, referred to as the PREFER study. METHODS The PREFER study, using a four-group design, includes: (1) a randomization scheme that permits participants to indicate a preferred dietary treatment approach, and (2) two dietary options, one of which is a lacto-ovo-vegetarian diet that has demonstrated potential for long-term adherence. The intervention (32 treatment sessions) is delivered over 12 months and is followed by a 6-month maintenance phase; final assessment occurs at 18 months. RESULTS We screened 932 individuals and randomized 197 to the study: Treatment Preference-Yes (n=84) and Treatment Preference-No (n=98). To maintain a balance across the four treatment groups, 15 subjects who preferred the standard diet had to be discarded from the Treatment Preference-Yes group. Retention at 18 months for the first of three cohorts was 82%. CONCLUSIONS The PREFER study is a single center study and is the first randomized controlled trial examining a lacto-ovo-vegetarian diet as part of weight loss treatment. The ethnically diverse sample includes males and females with a body mass index of 27 to 43. The study has the potential to make a contribution to understanding the role of treatment preference and the potential of a lacto-ovo-vegetarian diet for long-term weight loss.
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Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy.
Shepherd, FA, Dancey, J, Ramlau, R, Mattson, K, Gralla, R, O'Rourke, M, Levitan, N, Gressot, L, Vincent, M, Burkes, R, et al
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2000;(10):2095-103
Abstract
PURPOSE To evaluate whether treatment with single-agent docetaxel would result in longer survival than would best supportive care in patients with non-small-cell lung cancer who had previously been treated with platinum-based chemotherapy. Secondary end points included assessment of response (docetaxel arm only), toxicity, and quality of life. PATIENTS AND METHODS Patients with performance statuses of 0 to 2 and stage IIIB/IV non-small-cell lung cancer with either measurable or evaluable lesions were eligible for entry onto the study if they had undergone one or more platinum-based chemotherapy regimens and if they had adequate hematology and biochemistry parameters. They were excluded if they had symptomatic brain metastases or if they had previously been treated with paclitaxel. Patients were stratified by performance status and best response to cisplatin chemotherapy and were then randomized to treatment with docetaxel 100 mg/m(2) (49 patients) or 75 mg/m(2) (55 patients) or best supportive care. Patients in both arms were assessed every 3 weeks. RESULTS One hundred four patients (103 of whom were eligible for entry onto the study) were well balanced for prognostic factors. Of 84 patients with measurable lesions, six (7. 1%) achieved partial responses (three patients at each dose level). Time to progression was longer for docetaxel patients than for best supportive care patients (10.6 v 6.7 weeks, respectively; P <.001), as was median survival (7.0 v 4.6 months; log-rank test, P =.047). The difference was more significant for docetaxel 75 mg/m(2) patients, compared with corresponding best supportive care patients (7.5 v 4.6 months; log-rank test, P =.010; 1-year survival, 37% v 11%; chi(2) test, P =.003). Febrile neutropenia occurred in 11 patients treated with docetaxel 100 mg/m(2), three of whom died, and in one patient treated with docetaxel 75 mg/m(2). Grade 3 or 4 nonhematologic toxicity, with the exception of diarrhea, occurred at a similar rate in both the docetaxel and best supportive care groups. CONCLUSION Treatment with docetaxel is associated with significant prolongation of survival, and at a dose of 75 mg/m(2), the benefits of docetaxel therapy outweigh the risks.