1156 POSTER High dose palonosetron does not alter ECG parameters including QTc interval in healthy subjects: results of a dose-response, double blind, randomized, parallel E14 study of palonosetron vs. moxifloxacin or placebo

2007 ◽  
Vol 5 (4) ◽  
pp. 158-159 ◽  
Author(s):  
J. Morganroth ◽  
S. Parisi ◽  
C. Moresino ◽  
M. Thorn ◽  
M.T. Cullen
2019 ◽  
Vol 9 (2) ◽  
pp. 123
Author(s):  
Yosuke Hirayama ◽  
Jun Takanari ◽  
Kazunori Goto ◽  
Hiroshi Ueda ◽  
Aiko Tanaka ◽  
...  

Background: Welsh onion belongs to genus allium. Although its medicinal benefit such as cold prevention is well known by tradition, the underlying mechanism and active components have never been elucidated. The recent study revealed that Welsh onion mucus enhances tumor necrosis factor-α and monocyte chemotactic protein-1 production from RAW 264 cells and natural killer (NK) cell activity in murine spleen cells. This mucilage was abundant in the leaf blade of Welsh onion. Thus, we investigated the effect of Welsh onion green leaf extract (GLE) on immune competence in the human clinical trial. Methods: A randomized, double-blind, placebo-controlled trial was conducted. Fifty-five healthy subjects were enrolled after the screening based on NK cell activity, and each sample (placebo, low-dose GLE or high-dose GLE) was supplemented for four weeks. The immune competence activity was evaluated through the primary endpoints that were NK cell activity and the score of immunological vigor (SIV). The SIV was calculated from lymphocyte subset analysis by flow cytometry method.Results: NK cell activity was enhanced in all supplemented groups including placebo, especially, it was significant in both GLE groups. The result of immune score showed that the immunity of high-dose GLE group did not change although it was significantly lowered in placebo group (p<0.01), suggesting that GLE ameliorated the immunity suppression. In addition, when SIV was compared between pre- and post-intake, the ratios of the improved subjects in two GLE groups were higher than that of placebo group while those of the aggravated subjects showed the opposite result. In particular, they were remarkable in high-dose GLE group.Conclusion: These results suggest that the intake of low- or high-dose GLE might positively regulate immune competence.Keywords: welsh onion, immunity, natural killer cell, clinical trial


Nutrients ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 2319 ◽  
Author(s):  
Lin ◽  
Koppenol ◽  
Knol ◽  
Vermeer ◽  
Hiemstra ◽  
...  

Plant sterols (PS) are oxidized to PS oxidation products (POP). This study quantified the change in serum POP compared to cholesterol oxidation products (COP) after the intake of increasing POP doses. This was a double-blind, randomized, placebo-controlled, dose‒response pilot study with healthy individuals in four groups (15 per group). The control group received products with no added PS or POP and treatment groups received daily 20–25 g margarine with added PS (mean 3 g/d) and two cookies (~28 g) for six weeks. Cookies delivered 8.7 (low-dose), 15.2 (medium-dose), or 37.2 (high-dose) mg/d POP. Fasting serum POP and COP were measured at the baseline, days 14, 28, and 42 in all participants and days 7, 21, and 35 in a subset. Sixty individuals completed the study; 52 were included in per protocol analysis. Serum POP increased with increasing POP intake and plateaued at dose >15 mg/d. Stabilized POP concentrations were (mean ± SD) 38.9 ± 6.9, 91.0 ± 27.9, 144.4 ± 37.9 and 203.0 ± 63.7 nmol/L, for control, low-, medium-, and high-dose POP groups, respectively. For all groups, the serum COP ranged from 213 to 262 nmol/L and the average POP/COP ratio was <1. Serum POP concentrations increased non-linearly, reaching stabilized concentrations in <7 days, and remained below COP concentrations after the intake of increasing POP doses.


2007 ◽  
Vol 92 (1) ◽  
pp. 297-303 ◽  
Author(s):  
E. T. Vestergaard ◽  
R. Dall ◽  
K. H. W. Lange ◽  
M. Kjaer ◽  
J. S. Christiansen ◽  
...  

Abstract Context: We have previously shown that exercise-induced GH release is not mediated by ghrelin, but it remains to be studied whether the increase in GH may suppress postexercise ghrelin levels. Objective: The objective of this study was to characterize systemic ghrelin levels after exercise with and without concomitant GH administration. Design, Participants, and Intervention: Group A: Twenty-nine elite athletes (age, 18–37 yr) were studied after a maximal exercise test. Group B: In a double blind, placebo-controlled, parallel study, 32 healthy subjects (age, 18–33 yr) were randomized to placebo, GH 0.1 IU/kg per day, or GH 0.2 IU/kg per day for 4 wk. These subjects performed a multistage fitness test to assess maximum oxygen uptake at baseline and after 4 wk. We measured total circulating ghrelin levels before and immediately after exercise and at 15, 30, 60, 90, and 120 min after exercise. Results: Group A: Serum ghrelin levels after exercise decreased significantly (P &lt; 0.01). Group B: Exercise at baseline was associated with a significant lowering of ghrelin levels after exercise (P &lt; 0.0001). In addition, 4 wk of high-dose GH were followed by a further approximately 20% reduction in basal and after exercise serum ghrelin (micrograms per liter): 0.78 (range 0.52–1.17) vs. 0.63 (range 0.50–0.91), P &lt; 0.05. Conclusions: 1) Ghrelin levels decrease significantly after exercise in elite athletes and healthy subjects. 2) High-dose GH suppresses ghrelin levels. 3) These data support the hypothesis that GH feedback inhibits ghrelin secretion.


PLoS ONE ◽  
2013 ◽  
Vol 8 (10) ◽  
pp. e74107 ◽  
Author(s):  
Luciana Cadore Stefani ◽  
Suzana Muller ◽  
Iraci L. S. Torres ◽  
Bruna Razzolini ◽  
Joanna R. Rozisky ◽  
...  

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