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NCT03024879 Clinical Trial

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

Healthy Clinical Trial

Official title:
Influence of Erythromycin on ad Libitum Food Intake and the Evaluation of Motilin in Food Timing in Healthy Volunteers and Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03024879
Other study ID # MotilinAndFoodIntake
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received May 23, 2016
Last updated January 16, 2017
Start date March 2014

Study information
Verified date January 2017
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 15
Est. completion date
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Erythromycin

• Saline

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Frequency of food intake correlated with motilin plasma levels Assessment will be done over a period of 5 hours
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