Leon A S, Hunninghake D B, Bell C, Rassin D K, Tephly T R
Division of Epidemiology, School of Public Health, University of Minnesota, Minneapolis.
Arch Intern Med. 1989 Oct;149(10):2318-24.
Safety of long-term administration of 75 mg/kg of aspartame per day was evaluated with the use of a randomized, double-blind, placebo-controlled, parallel-group design in 108 male and female volunteers aged 18 to 62 years. Subjects received either aspartame or placebo in capsule form three times daily for 24 weeks. No persistent changes over time were noted in either group in vital signs; body weight; results of standard laboratory tests; fasting blood levels of aspartame's constituent amino acids (aspartic acid and phenylalanine), other amino acids, and methanol; or blood formate levels and 24-hour urinary excretion of formate. There also were no statistically significant differences between groups in the number of subjects experiencing symptoms or in the number of symptoms per subject. These results further document the safety of the long-term consumption of aspartame at doses equivalent to the amount of aspartame in approximately 10 L of beverage per day.
采用随机、双盲、安慰剂对照、平行组设计，对108名年龄在18至62岁之间的男性和女性志愿者进行了评估，以确定每天服用75毫克/千克阿斯巴甜的长期安全性。受试者每天三次服用胶囊形式的阿斯巴甜或安慰剂，持续24周。两组的生命体征、体重、标准实验室检查结果、阿斯巴甜组成氨基酸（天冬氨酸和苯丙氨酸）、其他氨基酸和甲醇的空腹血水平、血甲酸水平以及甲酸的24小时尿排泄量均未随时间出现持续变化。在出现症状的受试者数量或每位受试者的症状数量方面，两组之间也没有统计学上的显著差异。这些结果进一步证明了长期食用相当于每天约10升饮料中阿斯巴甜含量的阿斯巴甜的安全性。
