The Effect of L-lysine on Human Gastrointestinal Secretion: A Dose-finding Study Applying Magnetic Resonance Imaging (MRI)
Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
This is a pilot dose-finding study, which is performed with a randomized, double-blind,
3-armed, unbalanced, cross-over study design. Three of four different doses of L-lysine
Monohydrate (A = 0.5 g, B = 1.2 g, C = 3.0 g and D = 7.5 g) will be applied in a randomized
sequence on three different study days in six healthy volunteers. Each study day involves the
repeated measurement of gastric content volume, gastric secretion volume and intestinal fluid
volume using MRI before and after intragastric infusion of L-lysine Monohydrate test meals.
Additionally, symptoms for hunger, fullness, nausea, bloating, abdominal cramps and urge to
defecate will be recorded using a scale from 0-10. In parallel, samples of gastric juice to
measure intragastric pH and pepsin concentration, samples of venous blood to assess blood pH
and haematocrit as well as L-lysine, Serotonin, chloride bicarbonate and albumin plasma
concentration and samples of arterialized blood from ear lobe to measure glucose blood
concentration will be collected