NCT04005781

Effect of Bitter in Overweight Female Volunteers

The Effect of Hydroxychloroquine Sulphate on Hedonic Food Intake, Appetite-related Sensations and Gastrointestinal Hormone Release in Overweight Female Subjects

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

We want to investigate whether an acute administration of hydroxychloroquine sulphate affects hedonic food intake, appetite related sensations and gastrointestinal hormone release in overweight female subjects.

Detailed description

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. Forty overweight females will be recruited. 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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine sulphate	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.
DRUG	Placebo	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.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2019-07-02
• Last updated: 2019-07-02