Cross-linked Emulsion Study
This comparative pilot study is designed to compare the rates of gastric emptying and by inference rates of digestion of two food emulsions. Two types of milk protein stabilised food emulsion will be compared, one standard emulsion preparation and one emulsion preparation cross-linked with microbial transglutaminase. The information from this study will then be compared to data on satiety and endocrine hormones from a parallel study undertaken in Finland using the same two meal formulations. The drinks will be labeled with a stable isotope of carbon and samples of breath collected every 20 minutes after consumption of the drink. This will allow gastric residence time to be calculated. The pilot will also fulfill two secondary objectives. At the same time as the breath samples are collected MRI scans of the upper abdomen will be made so that gastric volumes can be measured in order to compare the two methods of measuring gastric emptying rates. Additionally, samples of saliva will also be collected after every MRI scan for subsequent mass spectrometry analysis. These are to assess the efficacy of mass spectrometry analysis for detection of the presence of specific digestion related hormones such as ghrelin.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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|
- Rate of gastric emptying by MRI [ Time Frame: 20 minute intervals over 3 hours ] [ Designated as safety issue: No ]rate measured from MRI images of gastric contents
- Gastric emptying by C13 [ Time Frame: every 20 minutes over 3 hours ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333020
|Norwich, Norfolk, United Kingdom, NR4 7UA|
|Principal Investigator:||Alan R Mackie, PhD||Institute of Food Research|