Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-05 @ 6:17 PM
Study NCT ID:
NCT04005768
Status:
UNKNOWN
Last Update Posted:
2019-07-02
First Post:
2019-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Hydroxychloroquine Sulphate in Healthy Lean Females
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Study Overview
Official Title:
The Effect of Hydroxychloroquine Sulphate on Hedonic Food Intake, Appetite-related Sensations and Gastrointestinal Hormone Release in Healthy Female Subjects
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLAQHV
Brief Summary:
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.
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. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: