Effect of Protein Composition on Gastric Emptying

Not Applicable

• Conditions: Cerebral Palsy; Gastric Dysmotility; Enteral Feeding

• Registration Number: NCT00345566
• Lead Sponsor: Ullevaal University Hospital

Brief Summary

The protein composition of nutrition may affect the rate of gastric emptying and gastric fysiology. This is espesially important in children with neurologic impariment, who commonly rely on tube feedings, have feeding problems, nausea, vomiting, gastroesophageal reflux and delayed gastric emptying. We aim to find out whether 4 different protein sources affect the rate of gastric emptying and electrofysiology in this group of children.

Detailed Description

Several factors in nutrition are known to affect gastric emptying rate, such as energy content, temperature, viscosity etc. In infants the protein composition affects gastric emptying. Children with cerebral pasly commonly have foregut dysmotility - with nausea, vomiting, feeding intolerance and gastroesophageal reflux. Tube feedings, usually based on cows milk are commonly used.

Our hypothesis is that the source and thus protein composition of feeding affects gastric emptying rate and electrofysiology.

Using four different tube feedings, standardized for content of fat, glucose and calories, we will measure gastric emptying rate using C13 octanoic acid as well as electrogastrography will be recorded. The protein modules are derived from casein, whey/casein mixture, hydrolyzed whey and aminoacids. Children with cerebral paresis and gastrostomy will be included. Each serves as his / her own control.

The primary endpoint is gastric emptying rate, the secondary endpoint electrogastrography.

Study Timeline

• Status Verified: 2006-06
• Study First Submitted: 2006-06-27
• Study First Submitted QC: 2006-06-27
• Last Update Submitted: 2006-06-27
• Study First Posted: 2006-06-28
• Last Update Posted: 2006-06-28
• Study Start: 2006-08
• Study Completion: 2007-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Cerebral paresis, user of tube feedings through gastrostomy -

Exclusion Criteria

Use of valproic acid (interferes with breath test). Age >16 y.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Gastric emptying, measured by octanoic acid breath test.

Secondary Outcome Measures

Name	Time	Method
Electrogastrography

Trial Locations

Locations (1)

Ullevaal university hospital; 🇳🇴 Oslo, Norway