Orlistat is a gastrointestinal lipase inhibitor that is used to reduce diet
ary fat absorption and to enhance weight loss in subjects consuming a hypoc
aloric diet. To assess whether orlistat has an effect on the metabolism of
six minerals, a 21-d, double-blind, randomized, parallel-group, placebo-con
trolled mineral balance study was conducted in obese (body mass index > 30
kg/m(2)) men. Subjects consumed a hypocaloric diet with a constant daily mi
neral content and received daily oral treatment with orlistat (120 mg three
times daily) (n = 14) or placebo (three times daily) (n = 14) for 21 d. Af
ter a 14-d equilibration period, calcium, phosphorus, magnesium, iron, copp
er and zinc balances were assessed for d 15-21. In addition, the effect of
diet and orlistat treatment on bone metabolism was estimated from measureme
nt of biomarkers of bone formation and bone resorption. Serum and urine ele
ctrolytes were also measured at baseline and at the end of treatment. Orlis
tat inhibited fat absorption by similar to 33% (P < 0.05). There were no si
gnificant differences in mineral apparent absorption, urinary mineral loss
or mineral balance between the orlistat and placebo groups. Markers of bone
turnover and serum and urine electrolytes did not differ between the orlis
tat and placebo groups. Orlistat was well tolerated; adverse events were of
mild or moderate intensity, and the majority of these events were unrelate
d or remotely related to study treatment. In obese men consuming a hypocalo
ric diet, the administration of orlistat had no significant effect on the b
alance of six selected minerals. In addition, biomarkers of bone turnover,
as well as serum and urine electrolytes, were not affected by orlistat trea
tment.