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Enrolling by Invitation

NCT Number: NCT03024879

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

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.

Enrolling by Invitation

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Key information

Conditions

Healthy Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythromycin

Drug

Saline

Drug

Primary outcomes

  1. 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 outcomes

  1. Frequency of food intake correlated with motilin plasma levels

    Time frame: Assessment will be done over a period of 5 hours

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Jan 19, 2017
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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