HealthyPhase 4NCT03024879
The Effect of Motilin on the Frequency and Amount of Food Intake
A Phase 4 study testing Erythromycin and Saline in people with Healthy and Obesity, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Erythromycin and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Influence of Erythromycin on ad Libitum Food Intake and the Evaluation of Motilin in Food Timing in Healthy Volunteers and Patients
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.
- Being tested
- Erythromycin, Saline
- Keywords
- Motilin, Erythromycin, Food intake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Erythromycin | Active comparator | 40 mg of erythromycin will be administered intravenously over a period of 20 min in a saline solution of 100 ml Receives: Drug: Erythromycin |
| Placebo | Placebo comparator | a saline solution of 100 ml will be administered intravenously over a period of 20 min Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in food intake, assessed by caloric intake, after intravenous administration of erythromycin compared to placebo
Measured: 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
Measured: Assessment will be done over a period of 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startMar 2014
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, Prof, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024879
- Sponsor's protocol ID
- MotilinAndFoodIntake
- Status last verified
- Jul 2024
- First submitted
- 23 May 2016
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29635488
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Erythromycin on ad Libitum Food Intake and the Evaluation of Motilin in Food Timing in Healthy Volunteers and Patients
- ClinicalTrials.gov ID
- NCT03024879
- Acronym / sponsor ID
- MotilinAndFoodIntake
- Keywords
- Motilin, Erythromycin, Food intake
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythromycin | Active comparator | Drug: Erythromycin40 mg of erythromycin will be administered intravenously over a period of 20 min in a saline solution of 100 ml |
| Placebo | Placebo comparator | Drug: Salinea saline solution of 100 ml will be administered intravenously over a period of 20 min |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erythromycin | Drug | Erythromycin |
| Saline | Drug | Placebo |
Primary outcome
Change in food intake, assessed by caloric intake, after intravenous administration of erythromycin compared to placebo
Time frame: Caloric intake will be assessed 1 hour after the start of infusion and the start of ad libitum food intake
1 secondary outcome
Frequency of food intake correlated with motilin plasma levels
Time frame: Assessment will be done over a period of 5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Derived from this study: PubMed 29635488Deloose 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack, Prof principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erythromycin and Saline in people with Healthy and Obesity, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in food intake, assessed by caloric intake, after intravenous administration of erythromycin compared to placebo (time frame: Caloric intake will be assessed 1 hour after the start of infusion and the start of ad libitum food intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03024879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.