Effect of Protein Composition on Gastric Emptying
Recruitment status was Not yet recruiting
Procedure: Nutrition composition
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Effect of the Protein Composition on the Gastric Emptying Rate in Children With Cerebral Paresis|
- Gastric emptying, measured by octanoic acid breath test.
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||December 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345566
|Contact: Groa B Johannesdottir, MDfirstname.lastname@example.org|
|Contact: Charlotte Brun, MDemail@example.com|
|Ullevaal university hospital|
|Oslo, Norway, 0407|
|Study Chair:||Ketil Stordal, PHD|