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The Effect of Motilin on the Frequency and Amount of Food Intake

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03024879
Recruitment Status : Unknown
Verified January 2017 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Enrolling by invitation
First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Healthy Obesity Drug: Erythromycin Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Influence of Erythromycin on ad Libitum Food Intake and the Evaluation of Motilin in Food Timing in Healthy Volunteers and Patients
Study Start Date : March 2014
Estimated Primary Completion Date : March 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Erythromycin
40 mg of erythromycin will be administered intravenously over a period of 20 min in a saline solution of 100 ml
Drug: Erythromycin
Placebo Comparator: Placebo
a saline solution of 100 ml will be administered intravenously over a period of 20 min
Drug: Saline

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Frequency of food intake correlated with motilin plasma levels [ Time Frame: Assessment will be done over a period of 5 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03024879

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Jan Tack, Prof Universitaire Ziekenhuizen Leuven

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT03024879    
Other Study ID Numbers: MotilinAndFoodIntake
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Food intake
Additional relevant MeSH terms:
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Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action