The effect of an acute administration of hydroxychloroquine sulphate will be investigated on hedonic food intake, appetite related sensations and gastrointestinal hormone release in healthy female subjects.
Intragastric administration of a quinine-solution has shown to decrease hedonic food intake in healthy female volunteers. The effect of a tablet containing hydroxychloroquine sulphate on hedonic food intake in overweight female individuals has not been studied to date. The primary outcome of the current study is to evaluate the effect of hydroxychloroquine sulphate on hedonic food intake, assessed by ad libitum food intake of a chocolate milkshake one hour after dosing. The study is a randomized, placebo-controlled, double blinded cross-over study. Ten healthy lean females will be recruited as a proof of concept, before testing hydroxychloroquine sulphate in overweight female subjects. An acute dose of 400 mg hydroxychloroquine sulphate will be administered. Blood samples will be collected at regular time points to measure gastrointestinal hormone release and whole blood glucose levels. Appetite-related sensations will be scored at regular time points on visual analog scales.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
10
After a stabilization period of 20 min and 10 min after the first blood collection, Plaquenil (Hydroxychloroquine sulfate) will be administered per os (total dose of 400 mg) in a randomized, double-blinded fashion.
After a stabilization period of 20 min and 10 min after the first blood collection, Placebo will be administered per os (2 tablets) in a randomized, double-blinded fashion.
The effect of hydroxychloroquine sulphate on hedonic food intake
Hedonic food intake will be assessed using a chocolate milkshake drinking task. Subjects are instructed to drink ad libitum from a chocolate milkshake until fully satiated. The milkshake will be weighted before and after the experiment. 1 g of chocolate milkshake = 1 kcal.
Time frame: 60 min after plaquenil or placebo administration
The effect of hydroxychloroquine sulphate on gastrointestinal hormone release
Gastrointestinal hormone release will be measured in plasma samples collected at regular time points to assess the release of ghrelin and motilin.
Time frame: First sample 10 min prior to administration. Followed by collections every 10 min after administration for a period of one hour. A final blood sample will be collected 30 min after consumption of the chocolate milkshake.
The effect of hydroxychloroquine sulphate on glucose
Whole blood glucose levels will be measured at regular time points with a blood glucose meter.
Time frame: First sample 10 min prior to administration. Followed by collections every 10 min after administration for a period of one hour. A final blood sample will be collected 30 min after consumption of the chocolate milkshake.
The effect of hydroxychloroquine sulphate on appetite-related sensations
Hunger, prospective food consumption, satiety, fullness, bloating, belching, cramps and pain will be scored by the subjects on visual analog scales of 100 mm.
Time frame: All appetite-related sensations will be scored every 10 min for a period of 110 minutes, starting 20 min before plaquenil or placebo administration and ending 90 min after administration.
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