Cross-linked Emulsion Study
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|ClinicalTrials.gov Identifier: NCT01333020|
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : June 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Other: cross-linking of an emulsion drink||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||A Pilot Study on the Effect of Protein Cross-linking on Gastric Layering and Emptying of a Food Emulsion|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: transglutaminase cross-linking of emulsion
The impact of enzyme cross linking of the protein stabilising the test emulsion on gastric emptying rate will be assessed. In this crossover study the subjects will also consume ( on a separate day)an emulsion of the same formulation but not cross-linked.
Other: cross-linking of an emulsion drink
This study will assess whether a subtle change in food structure (cross-linking of interfacial protein) can alter gastric emptying rate.
- Rate of gastric emptying by MRI [ Time Frame: 20 minute intervals over 3 hours ]rate measured from MRI images of gastric contents
- Gastric emptying by C13 [ Time Frame: every 20 minutes over 3 hours ]compare gastric emptying rates measured by MRI with those measured by 13C acetic acid breath tests.
- mass spectrometry detection of GI tract hormones in saliva [ Time Frame: every 20 minutes over 3 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333020
|Norwich, Norfolk, United Kingdom, NR4 7UA|
|Principal Investigator:||Alan R Mackie, PhD||Quadram Institute|