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

Overview

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.

Full Title of Study: “Influence of Erythromycin on ad Libitum Food Intake and the Evaluation of Motilin in Food Timing in Healthy Volunteers and Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2017

Interventions

  • Drug: Erythromycin
  • Drug: Saline

Arms, Groups and Cohorts

  • Active Comparator: Erythromycin
    • 40 mg of erythromycin will be administered intravenously over a period of 20 min in a saline solution of 100 ml
  • Placebo Comparator: Placebo
    • a saline solution of 100 ml will be administered intravenously over a period of 20 min

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Frequency of food intake correlated with motilin plasma levels
    • Time Frame: Assessment will be done over a period of 5 hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen KU Leuven
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jan Tack, Prof, Principal Investigator, Universitaire Ziekenhuizen KU Leuven

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