The effect of stomach contractions and bitter on food intake in healthy volunteers and patients

Phase 1

• Conditions: The effect of erythromycin administration on voluntary food intake will be tested in healthy volunteers, obese patients and patients with unexplained weight loss; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2013-004332-29-BE
• Lead Sponsor: ZLeuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-18
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

oBMI>30 kg/m² for the obese volunteers
oBMI<30 kg/m² for the lean volunteers
oSignificant unexplained weight loss
oFemale or male subjects aged 18 to 60
oSubject is capable and willing to give informed consent
oFemale volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception

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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

oFemale volunteer is pregnant or breastfeeding
oGI diseases, major abdominal surgery
oMajor psychiatric illnesses
oVolunteers that use drugs affecting the GI tract or the central nervous system
oVolunteers that suffer from diabetes mellitus
oVolunteers suffering from an endocrine disease such as diabetes, Cushing’s disease, Addison’s disease, hypothalamic tumor…
oVolunteers that have undergone surgical procedure for weight loss

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Linking fase 3 contractions and motilin to food intake through the adminsitration of erythromycin, which is a motilin receptor agonist and and induces phase III contractions;Secondary Objective: NA;Primary end point(s): The primary endpoint is to compare food intake between placebo and erythromycin adminsitration;Timepoint(s) of evaluation of this end point: Evaluation at the end of the trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA