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

January 16, 2017 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Caloric intake will be assessed 1 hour after the start of infusion and the start of ad libitum food intake

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Jan Tack, Prof, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

March 1, 2017

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

January 16, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MotilinAndFoodIntake

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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