Thirty-seven healthy volunteers, 19 of whom had consistently elevated
total serum bilirubin (TSB) concentrations, took part in an open, rand
omised cross-over study to determine the effect of fasting on TSB conc
entrations. The study comprised of two treatments. During one treatmen
t period volunteers ate a standard supper but fasted for 24 h thereaft
er. During the other treatment period volunteers ate a standard supper
, snacks, breakfast and lunch. TSB concentrations were measured at reg
ular intervals. In both the normal and high bilirubin groups, minimum
TSB values were recorded 4 h after the supper. A 24 h fast more than d
oubled TSB concentration from baseline values in both the normal and h
igh bilirubin groups. A clinically relevant rise in TSB took place aft
er 12 h into the fasting period (TSB of 17.3 mu mol 1(-1) in the faste
d group vs 14.0 mu mol 1(-1) in the non-fasted group). When designing
a clinical trial, selecting volunteers, or judging the tolerance of a
new drug, the rise in TSB caused by fasting must therefore be taken in
to account, particularly in trials where volunteers or patients fast b
efore entering the study.