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

May 3, 2011 updated by: University of Limerick

Does Domperidone, a D2-antagonist Alter Gastric Emptying Rates and Appetite Sensations in Healthy Adults?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Limerick, Ireland
        • Department of Physical Education & Sport Sciences, University of Limerick

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

10 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults aged 18-40 years

Exclusion Criteria:

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

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: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6.5 Hours post ingestion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6.5 hours post ingestion

Collaborators and Investigators

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

Sponsor

University of Limerick

Collaborators

Irish Research Council

Investigators

  • Principal Investigator: Amir Shafat, University of Limerick

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

February 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

May 3, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimate)

May 4, 2011

Study Record Updates

Last Update Posted (Estimate)

May 4, 2011

Last Update Submitted That Met QC Criteria

May 3, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DompGastEmpt

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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