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

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Unknown status

CT.gov ID

NCT03024879

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Frequency of food intake correlated with motilin plasma levels [Assessment will be done over a period of 5 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

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