Brain Mechanisms Underlying the Effect of the Motilin Receptor Agonist Erythromycin on Hunger in Normal Weight Subjects

The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on hunger, and the brain mechanism lying behind it.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Erythromycin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female only.
• 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.
• If female not known to be pregnant.
• Not known to have any past upper gastrointestinal surgery.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; intravenous infusion	Drug: Placebo; physiological saline
Experimental: Erythromycin; intravenous infusion	Drug: Erythromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional brain images	The functional brain images will be taken via functional magnetic resonance imaging (fMRI), and be analysed via a software called SPM.	40 min after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hunger scores	The hunger scores will be taken every 10 minutes since the scan starts via a 10 cm visual analogue scale.	every 10 minutes since the scan starts
gut hormones	Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure gut hormones (motilin, ghrelin, CCK, PYY, GLP-1) by radioimmuno-assay.	every 10 min since the scan starts

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven
• Investigators: Principal Investigator: Jan Tack, University of Leuven

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: August 6, 2014
• First Posted (Estimate): August 8, 2014

Study Record Updates

• Last Update Posted (Estimate): November 30, 2016
• Last Update Submitted That Met QC Criteria: November 29, 2016
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
• Other Study ID Numbers: Erythromycin_v6