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

NCT ID: NCT03024879

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Erythromycin

40 mg of erythromycin will be administered intravenously over a period of 20 min in a saline solution of 100 ml

Group Type ACTIVE_COMPARATOR

Erythromycin

Intervention Type DRUG

Placebo

a saline solution of 100 ml will be administered intravenously over a period of 20 min

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Interventions

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Erythromycin

Intervention Type DRUG

Saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Tack, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

References

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Deloose E, Biesiekierski JR, Vanheel H, Depoortere I, Tack J. Effect of motilin receptor activation on food intake and food timing. Am J Clin Nutr. 2018 Apr 1;107(4):537-543. doi: 10.1093/ajcn/nqx044.

Reference Type DERIVED
PMID: 29635488 (View on PubMed)

Other Identifiers

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MotilinAndFoodIntake

Identifier Type: -

Identifier Source: org_study_id

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