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

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT01347814
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-02
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-05
• Study First Submitted: 2011-05-03
• Study First Submitted QC: 2011-05-03
• Last Update Submitted: 2011-05-03
• Study First Posted: 2011-05-04
• Last Update Posted: 2011-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Healthy adults aged 18-40 years

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Gastric emptying half time	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

Name	Time	Method
Appetite sensations	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

Trial Locations

Locations (1)

Department of Physical Education & Sport Sciences, University of Limerick; 🇮🇪 Limerick, Ireland