Brain mechanisms underlying the hunger-inducing effect of erythromyci

Phase 1

• Conditions: The effect of erythromycin administration on hunger and brain responses will be tested in healthy volunteers; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2013-004411-53-BE
• Lead Sponsor: niversity of Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-04
• Study Completion: 2016-03-16
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 14

Inclusion Criteria

Female = 1
Age > 18 and < 60.
Body Mass Index (BMI) of 19-25 kg/m2 (no weight change of more than 5 kg in the past three months).
Not known to have any chronic medical illness or illnesses affecting the gastrointestinal, cardiovascular, or nervous systems, chronic pain or psychiatric disorder.
Not known to be pregnant.
Not known to have any past upper gastrointestinal surgery.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Alcohol consumption > 7 drinks / week
Major depression and chronic health conditions except controlled hypertension

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Replicate the established effect of intravenous erythromycin infusion on hunger, and figure out the brain and/or hormonal mechanisms underlying the effect.;Secondary Objective: NA;Primary end point(s): Brain responses to intravenous administration of 40 mg of erythromycin versus placebo in regions involved in homeostatic and hedonic control of food intake;Timepoint(s) of evaluation of this end point: 60 min after the start of the infusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Amount of intake of a chocolate milkshake in response to intravenous administration of 40 mg of erythromycin versus placebo;Timepoint(s) of evaluation of this end point: The time that subjects want to stop drinking the milkshake