Department of Surgery, Federal University of Ceará, Fortaleza, Ceará, Brazil.
Nutrition. 2010 Apr;26(4):375-81. doi: 10.1016/j.nut.2009.05.013. Epub 2009 Sep 17.
To evaluate the safety of nutraceutical oral administration of L-glutamine (L-Gln) in middle-aged and elderly individuals.
In this randomized, crossover, double-blind clinical study, 30 residents of a long-term-care institution, selected according to a modified SENIEUR protocol (Working Party of the EURAGE Concerted Action Programme on Ageing of the European Community), were studied. Fourteen subjects received orally 0.5 g kg(-1) d(-1) of L-Gln and 16 received calcium caseinate for 14 d, followed by a 5-d washout. Supplements were switched for the second 14-d trial. Laboratory tests for hepatic and renal functions and ammonemia were performed and the estimated glomerular filtration rate (eGFR) was calculated.
Of the 30 subjects, 16 were men, mean age was 69+/-8.8 y, average weight was 61.8+/-14.2 kg, and mean serum albumin was 4.0+/-0.3g/dL. Neither adverse clinical effects nor clinically significant laboratory changes were noted during L-Gln supplementation. There was no difference in ammonemia between the groups. There were statistically but not clinically significant increases in plasma urea nitrogen and creatinine concentrations. There was no significant decrease in eGFR during calcium caseinate supplementation (-2.9%). The eGFR decreased significantly after L-Gln supplementation (-13.3%) but well below the 25% limit for biologic significance.
Increases in serum urea nitrogen and creatinine and decrease in eGFR are probably due to difficulties by older kidneys in metabolizing the supplemented protein sources. Although not clinically significant, those alterations impose a rigorous control on the evaluation parameters of renal function during oral L-Gln supplementation, with doses of 0.5 g kg(-1) d(-1) in middle-aged and elderly individuals.
评估中老年人营养性口服 L-谷氨酰胺(L-Gln)的安全性。
在这项随机、交叉、双盲临床试验中,根据改良 SENIEUR 方案(欧洲共同体 EURAGE 协同行动老龄化工作组)选择了 30 名长期护理机构的居民。14 名受试者每天口服 0.5 g/kg 的 L-Gln,16 名受试者口服酪蛋白钙肽,持续 14 天,然后进行 5 天的洗脱期。在第二次 14 天的试验中切换补充剂。进行肝肾功能和血氨检测,并计算估计肾小球滤过率(eGFR)。
30 名受试者中,16 名男性,平均年龄 69+/-8.8 岁,平均体重 61.8+/-14.2kg,平均血清白蛋白 4.0+/-0.3g/dL。在 L-Gln 补充期间,既没有观察到不良的临床影响,也没有观察到临床上显著的实验室变化。两组之间血氨没有差异。血浆尿素氮和肌酐浓度有统计学但无临床意义的升高。在酪蛋白钙肽补充期间,eGFR 没有显著下降(-2.9%)。在 L-Gln 补充后,eGFR 显著下降(-13.3%),但远低于生物学意义上的 25%限值。
血清尿素氮和肌酐的增加以及 eGFR 的下降可能是由于老年肾脏在代谢补充的蛋白质来源方面存在困难所致。尽管没有临床意义,但这些改变在口服 L-Gln 补充期间对肾功能评估参数提出了严格的控制要求,对于中老年人,剂量为 0.5 g/kg/d。