Safety of long-term large doses of aspartame
A. S. Leon, D. B. Hunninghake, C. Bell, D. K. Rassin and T. R. Tephly
Division of Epidemiology, School of Public Health, University of Minnesota, Minneapolis.
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.
