Effect of Protein Composition on Gastric Emptying
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 27, 2006 | ||||||||
| Last Updated Date | June 27, 2006 | ||||||||
| Start Date ICMJE | August 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Gastric emptying, measured by octanoic acid breath test. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Electrogastrography | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Protein Composition on Gastric Emptying | ||||||||
| Official Title ICMJE | Effect of the Protein Composition on the Gastric Emptying Rate in Children With Cerebral Paresis | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Nutrition composition | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Enrollment ICMJE | 25 | ||||||||
| Completion Date | December 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Cerebral paresis, user of tube feedings through gastrostomy - Exclusion Criteria: Use of valproic acid (interferes with breath test). Age >16 y. - |
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| Gender | Both | ||||||||
| Ages | 1 Year to 16 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00345566 | ||||||||
| Other Study ID Numbers ICMJE | UUSKBK28200706 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Ullevaal University Hospital | ||||||||
| Collaborators ICMJE | Numico Europe | ||||||||
| Investigators ICMJE |
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| Information Provided By | Ullevaal University Hospital | ||||||||
| Verification Date | June 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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