Effect of 10mg Domperidone on Gastric Emptying of a High-fat Meal and Appetite Sensations in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01347814
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : May 4, 2011
Irish Research Council
Information provided by:
University of Limerick

Brief Summary:
The purpose of this study is to determine whether domperidone was sufficient to accelerate gastric emptying of a high-fat solid meal and reduce satiety responses in a healthy adult population.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Domperidone 10mg Drug: Placebo Not Applicable

Detailed Description:

This study aims to investigate the effect of domperidone on gastric emptying and appetite sensations in healthy subjects. Domperidone is a dopamine 2 (D2) receptor antagonist with claims of gastrointestinal tract pro-kinetic activity. Accelerated gastric emptying (GE) may lead to reduced satiation, increased food intake and is associated with obesity and diabetes mellitus. It is hypothesized that domperidone will increase gastric emptying rate and reduce satiety responses to a high-fat meal.

The effect of acute oral administration of 10 mg domperidone on gastric emptying of a high-fat pancake test meal, and subjective appetite sensations by visual analogue scale will be measured for six hours postprandially in a randomized, placebo-controlled, single-blinded manner in 13 healthy subjects.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Does Domperidone, a D2-antagonist Alter Gastric Emptying Rates and Appetite Sensations in Healthy Adults?
Study Start Date : February 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Domperidone

Intervention Details:
  • Drug: Domperidone 10mg
    10mg domperidone tablet 30 minutes before a test-meal.
    Other Name: Motilium
  • Drug: Placebo
    Homeopathic (Sugar) pill-Placebo
    Other Name: Homeopathic medicine; Silicea, 6c, Weleda, Derbyshire, UK

Primary Outcome Measures :
  1. Gastric emptying half time [ Time Frame: 6.5 Hours post ingestion ]
    Determination of Gastric emptying of a high-fat test meal measured by octanoic acid breath test after acute administration of 10mg domperidone

Secondary Outcome Measures :
  1. Appetite sensations [ Time Frame: 6.5 hours post ingestion ]
    Determination of appetite sensations associated with ingestion of a high-fat test meal by visual analogue scale after acute administration of 10mg domperidone

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy adults aged 18-40 years

Exclusion Criteria:

  • History of gastrointestinal-related conditions, diabetes mellitus or cardiovascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01347814

Department of Physical Education & Sport Sciences, University of Limerick
Limerick, Ireland
Sponsors and Collaborators
University of Limerick
Irish Research Council
Principal Investigator: Amir Shafat University of Limerick

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Amir Shafat/Dr, University of Limerick Identifier: NCT01347814     History of Changes
Other Study ID Numbers: DompGastEmpt
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: May 2011

Keywords provided by University of Limerick:
gastric emptying
diabetes mellitus
Pharmacologic Actions
Physiological Effects of Drugs
Gastrointestinal Agents

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action