The Effect of Motilin on the Frequency and Amount of Food Intake
Influence of Erythromycin on ad Libitum Food Intake and the Evaluation of Motilin in Food Timing in Healthy Volunteers and Patients
1 other identifier
interventional
15
0 countries
N/A
Brief Summary
In this study, the investigators aimed at evaluating the role of motilin in the regulation of food intake. Motilin, a gastrointestinal hormone, is a hunger signal in healthy volunteers and is significantly increased in obese patients. Its role in food intake regulation might contribute to the pathogenesis of obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 healthy
Started Mar 2014
Longer than P75 for phase_4 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 23, 2016
CompletedFirst Posted
Study publicly available on registry
January 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedJuly 10, 2024
July 1, 2024
11 years
May 23, 2016
July 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in food intake, assessed by caloric intake, after intravenous administration of erythromycin compared to placebo
Caloric intake will be assessed 1 hour after the start of infusion and the start of ad libitum food intake
Secondary Outcomes (1)
Frequency of food intake correlated with motilin plasma levels
Assessment will be done over a period of 5 hours
Study Arms (2)
Erythromycin
ACTIVE COMPARATOR40 mg of erythromycin will be administered intravenously over a period of 20 min in a saline solution of 100 ml
Placebo
PLACEBO COMPARATORa saline solution of 100 ml will be administered intravenously over a period of 20 min
Interventions
Eligibility Criteria
You may qualify if:
- BMI \< 30 kg/m² for lean volunteers
- BMI \> 30 kg/m² for obese volunteers
- Subject is capable and willing to give informed consent
- Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception
You may not qualify if:
- Female volunteer is pregnant or breastfeeding
- GI diseases, major abdominal surgery
- Major psychiatric illnesses
- Volunteers that use drugs affecting the GI tract or the central nervous system
- Volunteers suffering from endocrine diseases such as diabetes, Cushing's disease, Addison's disease, hypothalamic tumor
- Volunteers that have undergone surgical procedure for weight loss
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Deloose E, Biesiekierski JR, Vanheel H, Depoortere I, Tack J. Effect of motilin receptor activation on food intake and food timing. Am J Clin Nutr. 2018 Apr 1;107(4):537-543. doi: 10.1093/ajcn/nqx044.
PMID: 29635488DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Tack, Prof
Universitaire Ziekenhuizen KU Leuven
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2016
First Posted
January 19, 2017
Study Start
March 1, 2014
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
July 10, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share