Induction of artificial fat maldigestion by tetrahydrolipstatin assessed by the C-13-hiolein breath test in healthy volunteers - A double-blind controlled pilot study

Background: C-13-hiolein is a purified algal triglyceride which is synthesi zed with 98% of all carbon atoms of the molecule uniformly C-13-labeled. Or listat is the new name for tetrahydrolipstatin (THL), which is a specific a nd potent inhibitor of gastrointestinal lipases which induces artificial fa t malabsorption in humans. The aim of the present study was to use the C-13 -hiolein breath test (HBT) to assess THL-induced fat malabsorption in healt hy volunteers. Methods: Eight healthy volunteers of normal body weight unde rwent 2 study periods of 4 days of diet with or without THL 120 mg t.i.d, O n day 5, a HBT was performed. (CO2)-C-13 recovery in breath samples was mea sured over 24 h by isotope ratio mass spectrometry. Results: The peak (CO2) -C-13, excretion occurred only after 5 h in both treatment groups with litt le difference during the first 4h between the groups. THL potently reduced fat digestion and absorption with the most pronounced effect observed after 8 h: 1.1 +/- 0.2 vs. 2.3 +/- 0.3% dose in control experiments (p < 0.05). The 24-hour cumulative (CO2)-C-13 excretion was also significantly reduced by THL: 14.9 +/- 2.2 vs. 28.4 +/- 4.1% dose in control experiments (p < 0.0 5). In 6 of the 8 subjects, the cumulative (CO2)-C-13 excretion was lower w ith THL 120 mg t.i.d. than with placebo, Conclusion: The HBT well reflects THL-induced artificial fat maldigestion in healthy volunteers. Copyright (C ) 2000 S. Karger AG, Basel.