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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